<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/NCT03036254</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 15-0192</org_study_id>
    <nct_id>NCT03036254</nct_id>
  </id_info>
  <brief_title>Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk</brief_title>
  <official_title>Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An urgent need exists to identify effective interventions to arrest or reverse dementia and&#xD;
      cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will&#xD;
      investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive&#xD;
      functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive&#xD;
      impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen&#xD;
      therapy effects on cognition in diabetes. The potential to preserve, or even enhance,&#xD;
      cognition in elderly at high risk of cognitive decline and dementia has major implications&#xD;
      for the affected individuals and their support systems that bear the social and financial&#xD;
      burdens of long-term caregiving.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This resubmission responds to &quot;PAR-16-365-Pilot Clinical Trials for the Spectrum of&#xD;
      Alzheimer's Disease and Age-related Cognitive Decline (R01)&quot;. It will examine the efficacy of&#xD;
      hyperbaric oxygen therapy (HBOT) in improving cognitive functioning in cognitively impaired&#xD;
      elderly with diabetes (T2D), who have high risk for dementia. It is a collaboration of the&#xD;
      Icahn School of Medicine at Mount Sinai, NY, the University of Wisconsin, the Sagol Center&#xD;
      for Hyperbaric Medicine and Research at Asaf Harofeh Medical Center, Israel-one of the&#xD;
      world's largest and busiest hyperbaric units-and the Sheba Medical Center, Israel.&#xD;
&#xD;
      HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at&#xD;
      a pressure above the ambient atmosphere. The combined action of hyperoxia and hyperbaric&#xD;
      pressure leads to significant improvements in tissue oxygenation, resulting in&#xD;
      cerebrovascular benefits with improved ischemic damage and cerebral blood flow. Recently, the&#xD;
      researchers of this group published compelling evidence from clinical trials indicating HBOT&#xD;
      neurotherapeutic effects in stroke, with better cognitive function and elevated brain&#xD;
      activity in SPECT. New preliminary data suggests potential neurotherapeutic effects of HBOT&#xD;
      on T2D elderly with mild cognitive impairment (MCI), showing better cognitive performance and&#xD;
      brain activity. The researchers propose a randomized controlled clinical trial examining the&#xD;
      short (12 weeks) and long-term (12 months) efficacy of HBOT. The researchers will test&#xD;
      hypotheses that HBOT compared to a sham condition improves cognitive function and increases&#xD;
      cerebral blood flow and glucose utilization in MCI patients with T2D. Such patients are at&#xD;
      high dementia risk and enriched in cerebrovascular disease, and thus have high potential for&#xD;
      benefitting from HBOT. Aim 1 examines the potential beneficial effects of HBOT on cognition&#xD;
      (with a primary composite measure of executive functions and episodic memory, both affected&#xD;
      by T2D). Aim 2 examines effects of HBOT on ischemic injury which will be measured by CBF at&#xD;
      the level of capillaries in gray matter (by MRI arterial spin labeling), and in macrovessels&#xD;
      (by a novel 4D Flow MRI technology developed by the researchers of this group). Aim 3 focuses&#xD;
      on effects of HBOT on cerebral glucose utilization using [F18]FDG-PET. Finally, Aim 4&#xD;
      investigates mediation by the biomarkers, i.e. whether their inclusion in a mediation model&#xD;
      will attenuate the effect of HBOT on cognition, suggesting them as underlying mechanisms.&#xD;
      This study will be performed in Israel, where there is optimal infrastructure and expertise&#xD;
      for all the study components at significantly lower costs. HBOT can be widely deployed in the&#xD;
      US so if successful, this pilot study will provide the basis for a multi-center large-scale&#xD;
      clinical trial for definitive evidence of its benefits to cognition in T2D patients at high&#xD;
      dementia risk. Despite advances in the understanding of risk factors and the pathologic basis&#xD;
      for dementia, treatments are of very limited effects. As the proportion of elderly increases,&#xD;
      the accelerating prevalence of T2D and dementia amplifies this application's public health&#xD;
      impact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 8, 2017</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cognitive outcome</measure>
    <time_frame>baseline and 12 months</time_frame>
    <description>A balanced composite sum of z-scores of 4 executive function tests: (For Trails B, subjects draw lines connecting alternating numbers and letters; for Mazes, subjects draw lines from start to finish in mazes of increasing complexity; for Digit-Symbol, numbers and abstract symbols are paired in a legend, and subjects fill in the symbols for a series of numbers; and Category Fluency totals words for two categories, animals, and for fruit and vegetables. ) And 4 episodic memory tests (immediate and delayed recall - ADAS word list- Subjects read aloud 10 unrelated words on printed cards, and are asked to immediately recall as many as possible, in three learning trials. Delayed recall tests recall of the 10 words, after 15 minutes. Logical Memory subtest of the Wechsler Memory Scale-III is a paragraph recall test. The 1st story for immediate recall and for delayed recall, 15 minutes later will be used.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in secondary cognitive outcomes</measure>
    <time_frame>baseline and 12 months</time_frame>
    <description>The sum z-scores for 3 computer-based tests (not language dependent), developed through NIH; EXAMINER assessing executive abilities: http://examiner.ucsf.edu).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CDR-SB</measure>
    <time_frame>baseline and 12 months</time_frame>
    <description>Clinical Dementia Rating-Sum of Boxes (CDR-SB), which summarizes impairment in 6 domains (memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care) based on subject and informant interviews. Scores in each of these are combined to obtain a composite score ranging from 0 (no symptoms of dementia) through 3 (severe symptoms of dementia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADL questionnaire</measure>
    <time_frame>baseline and 12 months</time_frame>
    <description>The Barthel scale or Barthel ADL index used to measure performance in ADL with scoring from 0-20. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IADL questionnaire</measure>
    <time_frame>baseline and 12 months</time_frame>
    <description>The Lawton instrumental activities of daily living scale contains 8 items, with a summary score from 0 (low function) to 8 (high function).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">154</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>HBOT intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham intervention</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Except for pressure, all the conditions of the HBOT intervention are provided in the sham intervention (nurse measures vitals and asks about health before entering the chamber, time in the chamber, number of sessions per week and overall, nurse in the chamber at all times, mask on the face, etc.).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HBOT intervention</intervention_name>
    <description>HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at a pressure.&#xD;
HBOT intervention arm - 3 months of HBOT treatment, 9 months observation&#xD;
all participants receive HBOT treatment for 3 months at year 2</description>
    <arm_group_label>HBOT intervention</arm_group_label>
    <arm_group_label>Sham intervention</arm_group_label>
    <other_name>Hyperbaric oxygen therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham intervention</intervention_name>
    <description>Sham was selected as the control condition rather than &quot;usual care&quot; to equate intervention groups with respect to other variables that could influence cognition and functional status, such as a new challenge (completing an activity program), peer socialization, and attention from staff.</description>
    <arm_group_label>Sham intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of T2D&#xD;
&#xD;
          -  Diagnosis of MCI&#xD;
&#xD;
          -  &gt; the age of 65&#xD;
&#xD;
          -  Hebrew fluency&#xD;
&#xD;
          -  An informant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brain disease that affects cognition (e.g. Parkinson's disease, schizophrenia).&#xD;
&#xD;
          -  Stroke&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Chest pathology incompatible with HBOT&#xD;
&#xD;
          -  Inner ear disease&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Cholinesterase inhibitors&#xD;
&#xD;
          -  Subjects with an indication for HBOT&#xD;
&#xD;
          -  Counter-indication for MRI or PET&#xD;
&#xD;
          -  Individuals with severe cataracts must have cataract operations before enrolling in&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michal Schnaider-Beeri, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mary Sano, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michal Schnaider-Beeri, PhD</last_name>
    <phone>212-659-8807</phone>
    <email>michal.beeri@mssm.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ori Benari, M.Sc</last_name>
    <phone>(778) 382-7546</phone>
    <email>Ori.BenAri@sheba.health.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca West, PhD</last_name>
      <phone>212-659-5603</phone>
      <email>rebecca.west@mssm.edu</email>
    </contact>
    <contact_backup>
      <last_name>Michal Schnaider-Beeri, PhD</last_name>
      <phone>212-659-8807</phone>
      <email>michal.beeri@mssm.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Michal Schnaider-Beeri, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53076</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Bendlin, PhD</last_name>
      <phone>608-265-2483</phone>
      <email>bbb@medicine.wisc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jennifer Oh, M.A.</last_name>
      <phone>(608)265-9161</phone>
      <email>jmoh@medicine.wisc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Barbara Bendlin, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ramit Ravona, PhD</last_name>
      <phone>972-3-5303825</phone>
      <email>ramitrs@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Keren Koifman, BA</last_name>
      <email>Keren.Koifman@sheba.health.gov.il</email>
    </contact_backup>
    <investigator>
      <last_name>Ramit Ravona, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Assaf HaRofeh Medical Center</name>
      <address>
        <city>Tzrifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shai Efrati, MD</last_name>
      <phone>972-(0)8-977-9393/5</phone>
      <email>efratishai@013.net</email>
    </contact>
    <contact_backup>
      <last_name>Osha Meir, BA</last_name>
      <phone>972-8-9779393</phone>
    </contact_backup>
    <investigator>
      <last_name>Shai Efrati, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Michal Beeri</investigator_full_name>
    <investigator_title>Professor, Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified MRI and PET scans and cognitive scores will be made available for investigative collaborations. We expect to share these data with a large number of investigators throughout the world.</ipd_description>
  </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/NCT03036254
org study id: GCO 15-0192
nct id: NCT03036254
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
An urgent need exists to identify effective interventions to arrest or reverse dementia and
      cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will
      investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive
      functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive
      impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen
      therapy effects on cognition in diabetes. The potential to preserve, or even enhance,
      cognition in elderly at high risk of cognitive decline and dementia has major implications
      for the affected individuals and their support systems that bear the social and financial
      burdens of long-term caregiving.
This resubmission responds to "PAR-16-365-Pilot Clinical Trials for the Spectrum of
      Alzheimer's Disease and Age-related Cognitive Decline (R01)". It will examine the efficacy of
      hyperbaric oxygen therapy (HBOT) in improving cognitive functioning in cognitively impaired
      elderly with diabetes (T2D), who have high risk for dementia. It is a collaboration of the
      Icahn School of Medicine at Mount Sinai, NY, the University of Wisconsin, the Sagol Center
      for Hyperbaric Medicine and Research at Asaf Harofeh Medical Center, Israel-one of the
      world's largest and busiest hyperbaric units-and the Sheba Medical Center, Israel.

      HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at
      a pressure above the ambient atmosphere. The combined action of hyperoxia and hyperbaric
      pressure leads to significant improvements in tissue oxygenation, resulting in
      cerebrovascular benefits with improved ischemic damage and cerebral blood flow. Recently, the
      researchers of this group published compelling evidence from clinical trials indicating HBOT
      neurotherapeutic effects in stroke, with better cognitive function and elevated brain
      activity in SPECT. New preliminary data suggests potential neurotherapeutic effects of HBOT
      on T2D elderly with mild cognitive impairment (MCI), showing better cognitive performance and
      brain activity. The researchers propose a randomized controlled clinical trial examining the
      short (12 weeks) and long-term (12 months) efficacy of HBOT. The researchers will test
      hypotheses that HBOT compared to a sham condition improves cognitive function and increases
      cerebral blood flow and glucose utilization in MCI patients with T2D. Such patients are at
      high dementia risk and enriched in cerebrovascular disease, and thus have high potential for
      benefitting from HBOT. Aim 1 examines the potential beneficial effects of HBOT on cognition
      (with a primary composite measure of executive functions and episodic memory, both affected
      by T2D). Aim 2 examines effects of HBOT on ischemic injury which will be measured by CBF at
      the level of capillaries in gray matter (by MRI arterial spin labeling), and in macrovessels
      (by a novel 4D Flow MRI technology developed by the researchers of this group). Aim 3 focuses
      on effects of HBOT on cerebral glucose utilization using [F18]FDG-PET. Finally, Aim 4
      investigates mediation by the biomarkers, i.e. whether their inclusion in a mediation model
      will attenuate the effect of HBOT on cognition, suggesting them as underlying mechanisms.
      This study will be performed in Israel, where there is optimal infrastructure and expertise
      for all the study components at significantly lower costs. HBOT can be widely deployed in the
      US so if successful, this pilot study will provide the basis for a multi-center large-scale
      clinical trial for definitive evidence of its benefits to cognition in T2D patients at high
      dementia risk. Despite advances in the understanding of risk factors and the pathologic basis
      for dementia, treatments are of very limited effects. As the proportion of elderly increases,
      the accelerating prevalence of T2D and dementia amplifies this application's public health
      impact.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Cognitive outcome
time frame: baseline and 12 months
description: A balanced composite sum of z-scores of 4 executive function tests: (For Trails B, subjects draw lines connecting alternating numbers and letters; for Mazes, subjects draw lines from start to finish in mazes of increasing complexity; for Digit-Symbol, numbers and abstract symbols are paired in a legend, and subjects fill in the symbols for a series of numbers; and Category Fluency totals words for two categories, animals, and for fruit and vegetables. ) And 4 episodic memory tests (immediate and delayed recall - ADAS word list- Subjects read aloud 10 unrelated words on printed cards, and are asked to immediately recall as many as possible, in three learning trials. Delayed recall tests recall of the 10 words, after 15 minutes. Logical Memory subtest of the Wechsler Memory Scale-III is a paragraph recall test. The 1st story for immediate recall and for delayed recall, 15 minutes later will be used.)
measure: Change in secondary cognitive outcomes
time frame: baseline and 12 months
description: The sum z-scores for 3 computer-based tests (not language dependent), developed through NIH; EXAMINER assessing executive abilities: http://examiner.ucsf.edu).
measure: CDR-SB
time frame: baseline and 12 months
description: Clinical Dementia Rating-Sum of Boxes (CDR-SB), which summarizes impairment in 6 domains (memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care) based on subject and informant interviews. Scores in each of these are combined to obtain a composite score ranging from 0 (no symptoms of dementia) through 3 (severe symptoms of dementia).
measure: ADL questionnaire
time frame: baseline and 12 months
description: The Barthel scale or Barthel ADL index used to measure performance in ADL with scoring from 0-20. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
measure: IADL questionnaire
time frame: baseline and 12 months
description: The Lawton instrumental activities of daily living scale contains 8 items, with a summary score from 0 (low function) to 8 (high function).
arm group label: HBOT intervention
arm group type: Experimental
description: The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 30 minutes.
arm group label: Sham intervention
arm group type: Sham Comparator
description: Except for pressure, all the conditions of the HBOT intervention are provided in the sham intervention (nurse measures vitals and asks about health before entering the chamber, time in the chamber, number of sessions per week and overall, nurse in the chamber at all times, mask on the face, etc.).
intervention type: Device
intervention name: HBOT intervention
description: HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at a pressure.
HBOT intervention arm - 3 months of HBOT treatment, 9 months observation
all participants receive HBOT treatment for 3 months at year 2
arm group label: HBOT intervention
arm group label: Sham intervention
other name: Hyperbaric oxygen therapy
intervention type: Device
intervention name: Sham intervention
description: Sham was selected as the control condition rather than "usual care" to equate intervention groups with respect to other variables that could influence cognition and functional status, such as a new challenge (completing an activity program), peer socialization, and attention from staff.
arm group label: Sham intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Michal Schnaider-Beeri, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Mary Sano, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Michal Schnaider-Beeri, PhD
phone: 212-659-8807
email: michal.beeri@mssm.edu
last name: Ori Benari, M.Sc
phone: (778) 382-7546
email: Ori.BenAri@sheba.health.gov.il
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Israel
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Michal Beeri
investigator title: Professor, Psychiatry
mesh term: Dementia
mesh term: Diabetes Mellitus
sharing ipd: Yes
ipd description: De-identified MRI and PET scans and cognitive scores will be made available for investigative collaborations. We expect to share these data with a large number of investigators throughout the world.