<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/NCT03263247</url>
  </required_header>
  <id_info>
    <org_study_id>MCI cognitive training</org_study_id>
    <nct_id>NCT03263247</nct_id>
  </id_info>
  <brief_title>Cognitive Training in Patients With MCI Using fMRI</brief_title>
  <official_title>Randomized Double Blind Study on the Efficacy of Cognitive Training in Patients With Mild Cognitive Impairment Using fMRI.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>São Paulo State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ricardo Nitrini</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sonia Brucki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maira Okada de Oliveira</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Edson Amaro Junior</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maria da Graca M Martin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rodolfo dos Anjos</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Camila Carneiro Pedroza</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ana Carolina Cruz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aline Gisele Gonçalves</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Leticia Nery Celino de Souza Pak</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Letícia Ferreira da Mota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Paulo Rodrigo Bazán</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Isabella Maria Bello Avolio</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>São Paulo State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current project aims to investigate the efficacy of the visual imaging training (VIT) and&#xD;
      alphabet search training in comparison to an active control intervention, namely&#xD;
      psychoeducation information (PI) using fMRI in patients with amnestic mild cognitive&#xD;
      impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to&#xD;
      biomarkers (PET PIB, PET FDG and liquor).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will include 30 subjects with amnestic mild cognitive impairment (MCI) single domain or&#xD;
      multiple domain clinical diagnostic, over 60 years old, recruited through the Cognitive and&#xD;
      Behavioral Neurology Group ambulatory of University of Sao Paulo General Hospital. We will&#xD;
      also include 30 healthy subjects, over 60 years old, recruited in the community. All the&#xD;
      participants will be evaluated by neurologists specialized in cognitive neurology and&#xD;
      subjected to a neuropsychological assessment. The 30 participants with MCI and 30 healthy&#xD;
      subjects will be divided in 6 groups: the G1 MCI group (N=10) will receive 4 sessions of&#xD;
      visual imaging training; the G2 control group (N=10) will receive 4 sessions of visual&#xD;
      imaging training; the G3 MCI group (N=10) will receive psychoeducation intervention; the G4&#xD;
      control group (N=20) will receive psychoeducation intervention; the G5 MCI group (N=10) will&#xD;
      receive cognitive training with alphabet search training and the G6 control group will&#xD;
      receive cognitive training with alphabet search training. This will be a longitudinal,&#xD;
      randomized, double blind study. MCI patients will be grouped according to biomarkers (PET&#xD;
      PIB, PET FDG and liquor).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in functional magnetic resonance imaging (fMRI)</measure>
    <time_frame>Baseline and after 4 weeks of intervention fMRI correlates of behavioral performance</time_frame>
    <description>fMRI correlates of behavioral performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in memory and language measures</measure>
    <time_frame>Baseline and after 4 weeks of intervention - generalization</time_frame>
    <description>Improvement in Logical Memory Test I and II results and naming tests</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in perception of memory performance</measure>
    <time_frame>Baseline, within four weeks after intervention</time_frame>
    <description>Multifactorial Memory Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Visual Imaging Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive visual imaging training to facilitate learning of written information.&#xD;
Intervention: Visual Imaging Training in individual sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive information about memory functioning and aging.&#xD;
Intervention: behavioral: Psychoeducation in individual sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alphabet Search</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive alphabet search training.&#xD;
Intervention: Alphabet Search in individual sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Memory Training</intervention_name>
    <arm_group_label>Visual Imaging Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <arm_group_label>Psychoeducation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alphabet search</intervention_name>
    <arm_group_label>Alphabet Search</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Portuguese as native and preferred language; A minimum of 4 years of education;&#xD;
             MRI-compatible; Right-handed individuals; Normal corrected vision and hearing;&#xD;
             Estimated intelligence average or above (≥ 80 IQ); Amnestic Mild Cognitive Impairment&#xD;
             identified by a doctor and neuropsychological tests; Able to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of neurological disorder; History of serious systemic disease; History of&#xD;
             severe mental illness; Current untreated alcohol or substance abuse; Medical&#xD;
             conditions that compromise in any way the central nervous system; Presence of visual&#xD;
             impairment and / or hearing to preclude cognitive testing; Presence of&#xD;
             contraindications to MRI exam; Findings in structural MRI that can interfere with the&#xD;
             results of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>São Paulo State University</investigator_affiliation>
    <investigator_full_name>Eliane Mioto</investigator_full_name>
    <investigator_title>Prof. Dr Eliane C Miotto</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- 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/NCT03263247
org study id: MCI cognitive training
nct id: NCT03263247
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The current project aims to investigate the efficacy of the visual imaging training (VIT) and
      alphabet search training in comparison to an active control intervention, namely
      psychoeducation information (PI) using fMRI in patients with amnestic mild cognitive
      impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to
      biomarkers (PET PIB, PET FDG and liquor).
We will include 30 subjects with amnestic mild cognitive impairment (MCI) single domain or
      multiple domain clinical diagnostic, over 60 years old, recruited through the Cognitive and
      Behavioral Neurology Group ambulatory of University of Sao Paulo General Hospital. We will
      also include 30 healthy subjects, over 60 years old, recruited in the community. All the
      participants will be evaluated by neurologists specialized in cognitive neurology and
      subjected to a neuropsychological assessment. The 30 participants with MCI and 30 healthy
      subjects will be divided in 6 groups: the G1 MCI group (N=10) will receive 4 sessions of
      visual imaging training; the G2 control group (N=10) will receive 4 sessions of visual
      imaging training; the G3 MCI group (N=10) will receive psychoeducation intervention; the G4
      control group (N=20) will receive psychoeducation intervention; the G5 MCI group (N=10) will
      receive cognitive training with alphabet search training and the G6 control group will
      receive cognitive training with alphabet search training. This will be a longitudinal,
      randomized, double blind study. MCI patients will be grouped according to biomarkers (PET
      PIB, PET FDG and liquor).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Changes in functional magnetic resonance imaging (fMRI)
time frame: Baseline and after 4 weeks of intervention fMRI correlates of behavioral performance
description: fMRI correlates of behavioral performance
measure: Changes in memory and language measures
time frame: Baseline and after 4 weeks of intervention - generalization
description: Improvement in Logical Memory Test I and II results and naming tests
measure: Changes in perception of memory performance
time frame: Baseline, within four weeks after intervention
description: Multifactorial Memory Questionnaire
arm group label: Visual Imaging Training
arm group type: Experimental
description: Participants will receive visual imaging training to facilitate learning of written information.
Intervention: Visual Imaging Training in individual sessions
arm group label: Psychoeducation
arm group type: Active Comparator
description: Participants will receive information about memory functioning and aging.
Intervention: behavioral: Psychoeducation in individual sessions
arm group label: Alphabet Search
arm group type: Experimental
description: Participants will receive alphabet search training.
Intervention: Alphabet Search in individual sessions
intervention type: Behavioral
intervention name: Memory Training
arm group label: Visual Imaging Training
intervention type: Behavioral
intervention name: Psychoeducation
arm group label: Psychoeducation
intervention type: Behavioral
intervention name: Alphabet search
arm group label: Alphabet Search
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: São Paulo State University
investigator full name: Eliane Mioto
investigator title: Prof. Dr Eliane C Miotto
mesh term: Cognitive Dysfunction