<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02977819</url>
  </required_header>
  <id_info>
    <org_study_id>C16-38</org_study_id>
    <secondary_id>2016-A01767-44</secondary_id>
    <nct_id>NCT02977819</nct_id>
  </id_info>
  <brief_title>Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training</brief_title>
  <acronym>Age-Well</acronym>
  <official_title>Interventional Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training and Foreign Language Learning on Behavioral, Biological and Neuroimaging Measures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As the number of older people in Europe grows, increasing healthy life years is a priority.&#xD;
      As people live longer, ensuring good mental as well as physical health into later years is&#xD;
      becoming ever more important. Cognitive decline, dementia (e.g. Alzheimer's Disease, AD),&#xD;
      sleep disturbances and depression, all related to psychological distress and anxiety, are&#xD;
      significant drivers of reduced quality of life in older adults. This project builds on&#xD;
      evidence that meditation practice have the potential to downregulate these adverse factors&#xD;
      and positively impact mental and neurological conditions including AD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Understanding of the neurocognitive mechanisms of meditation is still limited. Meditation can&#xD;
      be conceptualized as &quot;a set of complex emotional and attentional regulation strategies&#xD;
      developed for a variety of purposes including the development of emotional well-being and&#xD;
      balance&quot;. Affective (emotional) and cognitive (attentional) control are therefore the most&#xD;
      likely mechanisms by which meditation could impact aging and AD. Specifically, meditation&#xD;
      could enhance the controlling role of mid-brain structures and the executive network over&#xD;
      structures involved in memory, emotions, and regulation of the immune system. This would lead&#xD;
      to better emotional and cognitive control which in turn would be associated with improved&#xD;
      mental and physical health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 24, 2016</start_date>
  <completion_date type="Anticipated">November 23, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 23, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimate the effect of an 18-month meditation intervention in non-meditating senior participants on the volume of the anterior cingulate cortex compared to a passive control intervention</measure>
    <time_frame>Visit 1 inclusion - Visit 3 Month 18</time_frame>
    <description>change in anterior cingulate cortex volume (T1-weighted MRI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate the effect of an 18-month meditation intervention in non-meditating senior participants on the perfusion of the anterior cingulate cortex compared to a passive control intervention</measure>
    <time_frame>Visit 1 inclusion - Visit 3 Month 18</time_frame>
    <description>change in anterior cingulate cortex perfusion (early PET-Amyvid® scan)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate the effect of an 18-month meditation intervention in non-meditating seniors on the volume of the insula compared to an 18 months intervention of learning a foreign language</measure>
    <time_frame>Visit 1 inclusion - Visit 3 Month 18</time_frame>
    <description>change in insula volume (T1-weighted MRI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate the effect of an 18-month meditation intervention in non-meditating seniors on the perfusion of the insula compared to an 18 months intervention of learning a foreign language</measure>
    <time_frame>Visit 1 inclusion - Visit 3 Month 18</time_frame>
    <description>change in insula perfusion (early PET-Amyvid® scan)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison between meditation intervention and language learning intervention on the global metacognitive composite score</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>consisting in the mean of the attentional, constructive and deconstructive subscores (main behavioural outcome) Each composite score is computed by averaging its respective standardised scale scores (range (-3) - (4) , Higher score of the meditation composite score mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite score per cognitive area assessed by the neuropsychological tests and the questionnaires</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>composite scores will be computed as z-scores calculated from all the cognitive scores obtained for the corresponding cognitive function that will have a normal distribution and will not have a floor or ceiling effect. Additional exploratory analyses will be conducted on all individual behavioural measures obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical neuroimaging using MRI: grey and white matter volume in all brain voxels</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>grey and white matter volume in all brain voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>hippocampal and hippocampal subfield volumes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical neuroimaging using MRI: brain perfusion in all brain voxels</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>brain perfusion in all brain voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical neuroimaging using MRI: fractional anisotropy and mean diffusivity in all brain voxels</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>fractional anisotropy and mean diffusivity in all brain voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical neuroimaging using MRI: number, size, type and location of white matter lesions</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>number, size, type and location of white matter lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical neuroimaging using MRI: magnetic susceptibility index in all brain voxels</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>magnetic susceptibility index in all brain voxels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical neuroimaging using MRI: brain functional connectivity measures in all brain voxels at rest in a non-meditative state</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>brain functional connectivity measures in all brain voxels at rest in a non-meditative state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta-amyloid charge (of the radiopharmarceutical Amyvid®) measured in each voxel of the brain and gross mean in gray matter</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>measured in each voxel of the brain and gross mean in gray matter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum)</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum) by TEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical neuroimaging using fMRI: Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task.</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical neuroimaging using fMRI: Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task.</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical neuroimaging using PET-scan and Amyvid® radiotracer</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Brain amyloid load (of the PET-Amyvid® radiotracer) measured in global grey matter mask</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjectives sleep measures with sleep quality index z-score mean of the scores at questionnaires</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Epworth scale, Leeds Sleep evaluation questionnaire, Pittsburg Sleep Quality Scale, St Mary's hospital questionnaire, Berlin Questionnaire, and Insomnia severity index.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean duration of sleep</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Data collected by actimetrics record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fragmentation indices during activity and resting states</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Data collected by actimetrics record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>regularity of the rest-activity cycle</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Data collected by actimetrics record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean z-score of total sleep time</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Data collected during polysomnographic sleep record with Somno-Art device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean z-score of sleep onset latency</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Data collected during polysomnographic sleep record with Somno-Art device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean z-score of sleep efficiency</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Data collected during polysomnographic sleep record with Somno-Art device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological blood tests</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>tau, phosphotau, Ab 40, 42, APOE4, NFL, BDNF, GWAS, cytokines, CRP, cortisol, serotonine, SDHEA, SHBG, E2, testosterone, glycemie, insuline, BNP, tPA, PAI-1, peroxyredoxine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telomerase properties by blood tests</measure>
    <time_frame>visit 1 baseline -Visit 3 18 months</time_frame>
    <description>Telomerasic activity, telomerase length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lymphocytic immunophenotyping</measure>
    <time_frame>visit 1 baseline -Visit 3 18 months</time_frame>
    <description>biological blood tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in partner perceptions of participant mindfulness measured by Five-Facet Mindfulness Questionnaire (FFMQ-15, range 15-75, higher scores indicate greater mindfulness)</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in partner perceptions of participant compassion towards others measured by Compassionate Love Scale (Range 21-147, higher scores indicate greater compassion)</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in partner perceptions of participant depression measured by the Geriatric Depression Scale (range 0-15, higher scores indicate greater depressive symptoms)</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores to evaluate the impact on volunteers' relatives</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>scores to hetero questionnaires fulfilled by relatives and qualitative data from interviews with the participants on one hand and with the teachers on the other hand</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in partner perceptions of participant anxiety measured by trait subscale of the state-trait anxiety inventory (trait-STAI, range 20-80, higher scores indicate greater anxiety symptoms)</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in partner perceptions of participant prosocialness measured by Prosocialness scale (range 16-80, higher scores indicate greater prosocialness)</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in partner perceptions of participant's cognitive difficulties in everyday life, measured by Mc Nair CDS (range 0-156, higher score indicates greater cognitive difficulties)</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neural signature of meditative practices using brain medical imaging (neuronal activity in each cerebral voxel (fMRI) at rest and during the emotional task, in a mindfulness meditative state versus not; in compasional meditative state or not)</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>only for meditation experts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and acceptance</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>recording adverse events, measurement of anxiety, depression, satisfaction, and well-being using questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of the practice of the meditation practice and language learning at long-term (29 months post-intervention)</measure>
    <time_frame>up to 35 months post intervention (because V4 = 29 months post intervention with a window of 6 months</time_frame>
    <description>questionnaire about the practice (meditation or foreign language)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral measures (questionnaires) to evaluate the psychological impact of the confinement</measure>
    <time_frame>up to 35 months post intervention</time_frame>
    <description>composite score per function (anxiety, stress, auto-compassion...)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Cognitive Aging</condition>
  <arm_group>
    <arm_group_label>Meditation program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Meditation courses and at-home practice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>English learning courses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>English learning courses and at-home practice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Follow-up without Meditation courses or English Learning courses</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meditation practice</intervention_name>
    <description>18 months</description>
    <arm_group_label>Meditation program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Learning English as a foreign language</intervention_name>
    <description>18 months</description>
    <arm_group_label>English learning courses</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Inclusion Criteria :&#xD;
&#xD;
             For all participants&#xD;
&#xD;
               -  Age ≥ 65 years ;&#xD;
&#xD;
               -  To be autonomous&#xD;
&#xD;
               -  Live in their home;&#xD;
&#xD;
               -  Educational level ≥ 7 years (from the Preparatory Course (First grade) included);&#xD;
&#xD;
               -  To be registered to the social security system ;&#xD;
&#xD;
               -  To be motivated to effectively participate in the project and to sign the consent&#xD;
                  form in agreement with the local ethic committee ;&#xD;
&#xD;
               -  Neuropsychological performances within the normal range (according to age, sex,&#xD;
                  and educational level), as assessed by the diagnostic battery.&#xD;
&#xD;
             For participants without previous meditation practice&#xD;
&#xD;
               -  French mother tongue;&#xD;
&#xD;
               -  Available for the trial duration (24 months);&#xD;
&#xD;
               -  Retired since 1 year or more;&#xD;
&#xD;
               -  No preference regarding the intervention group ;&#xD;
&#xD;
               -  Not having regularly or intensively practiced meditation or comparable practices&#xD;
                  (yoga, Qi Gong, Alexander technique) as follows :&#xD;
&#xD;
                    -  more than one day per week for more than six months consecutively over the&#xD;
                       last 10 years,&#xD;
&#xD;
                    -  intensively (internship or retreat &gt; five consecutive days) over the past 10&#xD;
                       years,&#xD;
&#xD;
                    -  more than 25 days of retreats (cumulatively) prior to the last 10 years ;&#xD;
&#xD;
               -  Not speaking English fluently.&#xD;
&#xD;
             For expert meditators :&#xD;
&#xD;
               -  Formal meditation practice &gt; 10 000 hours in the whole life, including at least 6&#xD;
                  cumulated months of retreat;&#xD;
&#xD;
               -  Daily meditation practice (at least 6 days/week, 45 minutes/day);&#xD;
&#xD;
               -  Mindfulness meditation practice (i.e. mindfulness, samatha/vipassana, zazen&#xD;
                  (zen), shikantaza (zen), focused attention, mahamudra/Dzogchen, and&#xD;
                  compassion/loving jindness (tonglen, metta/karuna, bodhichitta)&#xD;
&#xD;
          2. Exclusion criteria :&#xD;
&#xD;
               -  Contraindication to MRI or PET Amyvid® ;&#xD;
&#xD;
               -  For security reasons realted with the use of Amyvid®, a blood sampling allowing&#xD;
                  to measure hepatic and renal functions will be performed at the V1 visit before&#xD;
                  the PET-Amyvid® scan. In case anomalies are detected of grade 3 or higher&#xD;
                  severity, the PET-Amyvid® scan will not be performed.&#xD;
&#xD;
               -  Hypersensitivity to Amyvid®&#xD;
&#xD;
               -  History or presence of a major neurological or psychiatric disorder (including an&#xD;
                  addiction to alcohol or drugs);&#xD;
&#xD;
               -  History of cerebral disease (vascular, degenerative, physical malformation,&#xD;
                  tumor, or head trauma with loss of consciousness for more than an hour);&#xD;
&#xD;
               -  Presence of a chronic disease or acute unstable illness (respiratory,&#xD;
                  cardiovascular, digestive, renal, metabolic, hematologic, endocrine or&#xD;
                  infectious);&#xD;
&#xD;
               -  Current or recent medication that may interfere with cognitive action or&#xD;
                  radiological measures (psychotropic drugs, antihistamines, anti-Parkinsonian&#xD;
                  drugs, benzodiazepines, non-steroidal anti-inflammatory agents, antiepileptics,&#xD;
                  central analgesic and muscle relaxants);&#xD;
&#xD;
               -  Under legal guardianship or incapacitation;&#xD;
&#xD;
               -  Inclusion in another biomedical research protocol at baseline, if including use&#xD;
                  of a radiolabel for radiological measures;&#xD;
&#xD;
               -  Physical of behavioural inhabilities to perform the follow-up visits as planned&#xD;
                  in the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>De La Sayette Vincent</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Caen - France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chételat Gaël</last_name>
    <role>Study Director</role>
    <affiliation>GIP Cyceron Caen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GIP Cyceron</name>
      <address>
        <city>Caen</city>
        <state>Calvados</state>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Poisnel G, Arenaza-Urquijo E, Collette F, Klimecki OM, Marchant NL, Wirth M, de La Sayette V, Rauchs G, Salmon E, Vuilleumier P, Frison E, Maillard A, Vivien D, Lutz A, Chetelat G; Medit-Ageing Research Group. The Age-Well randomized controlled trial of the Medit-Ageing European project: Effect of meditation or foreign language training on brain and mental health in older adults. Alzheimers Dement (N Y). 2018 Dec 14;4:714-723. doi: 10.1016/j.trci.2018.10.011. eCollection 2018.</citation>
    <PMID>30581977</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data access of AGE-WELL and SCD-WELL studies of the MEDIT-AGEING project for which Institut national de la santé et de la recherche médicale (Inserm) is the sponsor. The Material can be mobilized, under the conditions and modalities defined in the Charter, by any research team belonging to an Academic signatory to the Consortium Agreement concluded for the needs of the Project or by any research team belonging to an Academic outside the Consortium Agreement, French or foreign, for carrying out SRP relating to the scientific theme of mental health and wellbeing in older people.&#xD;
The Material may also be mobilized, by non-academic third parties for the realization of SRP relating to the scientific theme of mental health and wellbeing in older people, under conditions, in particular financial, which will be established by separate agreement between Inserm and by the said third party.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>December 2020</ipd_time_frame>
    <ipd_access_criteria>specific information (quantity of Data available on a given date, number of patients included in the Cohort meeting the specific selection criteria for SRP requests, etc.) necessary for the conception of the SRP request;&#xD;
the price list for the mobilization of Data within the framework of the SRP.&#xD;
the list of services likely to be performed by the signatories of the Consortium Agreement for the purposes of the SRP request, as well as the associated price list;&#xD;
a quote for services not included in the price list.</ipd_access_criteria>
    <ipd_url>https://silversantestudy.fr/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02977819
org study id: C16-38
secondary id: 2016-A01767-44
nct id: NCT02977819
lead sponsor: 
has dmc: Yes
As the number of older people in Europe grows, increasing healthy life years is a priority.
      As people live longer, ensuring good mental as well as physical health into later years is
      becoming ever more important. Cognitive decline, dementia (e.g. Alzheimer's Disease, AD),
      sleep disturbances and depression, all related to psychological distress and anxiety, are
      significant drivers of reduced quality of life in older adults. This project builds on
      evidence that meditation practice have the potential to downregulate these adverse factors
      and positively impact mental and neurological conditions including AD.
Understanding of the neurocognitive mechanisms of meditation is still limited. Meditation can
      be conceptualized as "a set of complex emotional and attentional regulation strategies
      developed for a variety of purposes including the development of emotional well-being and
      balance". Affective (emotional) and cognitive (attentional) control are therefore the most
      likely mechanisms by which meditation could impact aging and AD. Specifically, meditation
      could enhance the controlling role of mid-brain structures and the executive network over
      structures involved in memory, emotions, and regulation of the immune system. This would lead
      to better emotional and cognitive control which in turn would be associated with improved
      mental and physical health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Estimate the effect of an 18-month meditation intervention in non-meditating senior participants on the volume of the anterior cingulate cortex compared to a passive control intervention
time frame: Visit 1 inclusion - Visit 3 Month 18
description: change in anterior cingulate cortex volume (T1-weighted MRI)
measure: Estimate the effect of an 18-month meditation intervention in non-meditating senior participants on the perfusion of the anterior cingulate cortex compared to a passive control intervention
time frame: Visit 1 inclusion - Visit 3 Month 18
description: change in anterior cingulate cortex perfusion (early PET-Amyvid® scan)
measure: Estimate the effect of an 18-month meditation intervention in non-meditating seniors on the volume of the insula compared to an 18 months intervention of learning a foreign language
time frame: Visit 1 inclusion - Visit 3 Month 18
description: change in insula volume (T1-weighted MRI)
measure: Estimate the effect of an 18-month meditation intervention in non-meditating seniors on the perfusion of the insula compared to an 18 months intervention of learning a foreign language
time frame: Visit 1 inclusion - Visit 3 Month 18
description: change in insula perfusion (early PET-Amyvid® scan)
measure: Comparison between meditation intervention and language learning intervention on the global metacognitive composite score
time frame: up to 35 months post intervention
description: consisting in the mean of the attentional, constructive and deconstructive subscores (main behavioural outcome) Each composite score is computed by averaging its respective standardised scale scores (range (-3) - (4) , Higher score of the meditation composite score mean better outcome)
measure: Composite score per cognitive area assessed by the neuropsychological tests and the questionnaires
time frame: up to 35 months post intervention
description: composite scores will be computed as z-scores calculated from all the cognitive scores obtained for the corresponding cognitive function that will have a normal distribution and will not have a floor or ceiling effect. Additional exploratory analyses will be conducted on all individual behavioural measures obtained.
measure: Medical neuroimaging using MRI: grey and white matter volume in all brain voxels
time frame: up to 35 months post intervention
description: grey and white matter volume in all brain voxels
measure: Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes
time frame: up to 35 months post intervention
description: hippocampal and hippocampal subfield volumes
measure: Medical neuroimaging using MRI: brain perfusion in all brain voxels
time frame: up to 35 months post intervention
description: brain perfusion in all brain voxels
measure: Medical neuroimaging using MRI: fractional anisotropy and mean diffusivity in all brain voxels
time frame: up to 35 months post intervention
description: fractional anisotropy and mean diffusivity in all brain voxels
measure: Medical neuroimaging using MRI: number, size, type and location of white matter lesions
time frame: up to 35 months post intervention
description: number, size, type and location of white matter lesions
measure: Medical neuroimaging using MRI: magnetic susceptibility index in all brain voxels
time frame: up to 35 months post intervention
description: magnetic susceptibility index in all brain voxels
measure: Medical neuroimaging using MRI: brain functional connectivity measures in all brain voxels at rest in a non-meditative state
time frame: up to 35 months post intervention
description: brain functional connectivity measures in all brain voxels at rest in a non-meditative state
measure: Beta-amyloid charge (of the radiopharmarceutical Amyvid®) measured in each voxel of the brain and gross mean in gray matter
time frame: up to 35 months post intervention
description: measured in each voxel of the brain and gross mean in gray matter
measure: Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum)
time frame: up to 35 months post intervention
description: Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum) by TEP
measure: Medical neuroimaging using fMRI: Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task.
time frame: up to 35 months post intervention
description: Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task.
measure: Medical neuroimaging using fMRI: Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task.
time frame: up to 35 months post intervention
description: Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task.
measure: Medical neuroimaging using PET-scan and Amyvid® radiotracer
time frame: up to 35 months post intervention
description: Brain amyloid load (of the PET-Amyvid® radiotracer) measured in global grey matter mask
measure: Subjectives sleep measures with sleep quality index z-score mean of the scores at questionnaires
time frame: up to 35 months post intervention
description: Epworth scale, Leeds Sleep evaluation questionnaire, Pittsburg Sleep Quality Scale, St Mary's hospital questionnaire, Berlin Questionnaire, and Insomnia severity index.
measure: Mean duration of sleep
time frame: up to 35 months post intervention
description: Data collected by actimetrics record
measure: fragmentation indices during activity and resting states
time frame: up to 35 months post intervention
description: Data collected by actimetrics record
measure: regularity of the rest-activity cycle
time frame: up to 35 months post intervention
description: Data collected by actimetrics record
measure: Mean z-score of total sleep time
time frame: up to 35 months post intervention
description: Data collected during polysomnographic sleep record with Somno-Art device
measure: Mean z-score of sleep onset latency
time frame: up to 35 months post intervention
description: Data collected during polysomnographic sleep record with Somno-Art device
measure: Mean z-score of sleep efficiency
time frame: up to 35 months post intervention
description: Data collected during polysomnographic sleep record with Somno-Art device
measure: Biological blood tests
time frame: up to 35 months post intervention
description: tau, phosphotau, Ab 40, 42, APOE4, NFL, BDNF, GWAS, cytokines, CRP, cortisol, serotonine, SDHEA, SHBG, E2, testosterone, glycemie, insuline, BNP, tPA, PAI-1, peroxyredoxine
measure: Telomerase properties by blood tests
time frame: visit 1 baseline -Visit 3 18 months
description: Telomerasic activity, telomerase length
measure: lymphocytic immunophenotyping
time frame: visit 1 baseline -Visit 3 18 months
description: biological blood tests
measure: Difference in partner perceptions of participant mindfulness measured by Five-Facet Mindfulness Questionnaire (FFMQ-15, range 15-75, higher scores indicate greater mindfulness)
time frame: up to 35 months post intervention
description: Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant.
measure: Difference in partner perceptions of participant compassion towards others measured by Compassionate Love Scale (Range 21-147, higher scores indicate greater compassion)
time frame: up to 35 months post intervention
description: Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
measure: Difference in partner perceptions of participant depression measured by the Geriatric Depression Scale (range 0-15, higher scores indicate greater depressive symptoms)
time frame: up to 35 months post intervention
description: Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
measure: Scores to evaluate the impact on volunteers' relatives
time frame: up to 35 months post intervention
description: scores to hetero questionnaires fulfilled by relatives and qualitative data from interviews with the participants on one hand and with the teachers on the other hand
measure: Difference in partner perceptions of participant anxiety measured by trait subscale of the state-trait anxiety inventory (trait-STAI, range 20-80, higher scores indicate greater anxiety symptoms)
time frame: up to 35 months post intervention
description: Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
measure: Difference in partner perceptions of participant prosocialness measured by Prosocialness scale (range 16-80, higher scores indicate greater prosocialness)
time frame: up to 35 months post intervention
description: Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
measure: Difference in partner perceptions of participant's cognitive difficulties in everyday life, measured by Mc Nair CDS (range 0-156, higher score indicates greater cognitive difficulties)
time frame: up to 35 months post intervention
description: Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
measure: Neural signature of meditative practices using brain medical imaging (neuronal activity in each cerebral voxel (fMRI) at rest and during the emotional task, in a mindfulness meditative state versus not; in compasional meditative state or not)
time frame: up to 35 months post intervention
description: only for meditation experts
measure: Safety and acceptance
time frame: up to 35 months post intervention
description: recording adverse events, measurement of anxiety, depression, satisfaction, and well-being using questionnaires
measure: evaluation of the practice of the meditation practice and language learning at long-term (29 months post-intervention)
time frame: up to 35 months post intervention (because V4 = 29 months post intervention with a window of 6 months
description: questionnaire about the practice (meditation or foreign language)
measure: Behavioral measures (questionnaires) to evaluate the psychological impact of the confinement
time frame: up to 35 months post intervention
description: composite score per function (anxiety, stress, auto-compassion...)
arm group label: Meditation program
arm group type: Experimental
description: Meditation courses and at-home practice
arm group label: English learning courses
arm group type: Active Comparator
description: English learning courses and at-home practice
arm group label: No intervention
arm group type: No Intervention
description: Follow-up without Meditation courses or English Learning courses
intervention type: Other
intervention name: Meditation practice
description: 18 months
arm group label: Meditation program
intervention type: Other
intervention name: Learning English as a foreign language
description: 18 months
arm group label: English learning courses
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: De La Sayette Vincent
role: Principal Investigator
affiliation: CHU Caen - France
last name: Chételat Gaël
role: Study Director
affiliation: GIP Cyceron Caen
facility: 
country: France
citation: Poisnel G, Arenaza-Urquijo E, Collette F, Klimecki OM, Marchant NL, Wirth M, de La Sayette V, Rauchs G, Salmon E, Vuilleumier P, Frison E, Maillard A, Vivien D, Lutz A, Chetelat G; Medit-Ageing Research Group. The Age-Well randomized controlled trial of the Medit-Ageing European project: Effect of meditation or foreign language training on brain and mental health in older adults. Alzheimers Dement (N Y). 2018 Dec 14;4:714-723. doi: 10.1016/j.trci.2018.10.011. eCollection 2018.
PMID: 30581977
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Data access of AGE-WELL and SCD-WELL studies of the MEDIT-AGEING project for which Institut national de la santé et de la recherche médicale (Inserm) is the sponsor. The Material can be mobilized, under the conditions and modalities defined in the Charter, by any research team belonging to an Academic signatory to the Consortium Agreement concluded for the needs of the Project or by any research team belonging to an Academic outside the Consortium Agreement, French or foreign, for carrying out SRP relating to the scientific theme of mental health and wellbeing in older people.
The Material may also be mobilized, by non-academic third parties for the realization of SRP relating to the scientific theme of mental health and wellbeing in older people, under conditions, in particular financial, which will be established by separate agreement between Inserm and by the said third party.
ipd info type: Study Protocol
ipd time frame: December 2020
ipd access criteria: specific information (quantity of Data available on a given date, number of patients included in the Cohort meeting the specific selection criteria for SRP requests, etc.) necessary for the conception of the SRP request;
the price list for the mobilization of Data within the framework of the SRP.
the list of services likely to be performed by the signatories of the Consortium Agreement for the purposes of the SRP request, as well as the associated price list;
a quote for services not included in the price list.
ipd url: https://silversantestudy.fr/