xml: <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/NCT05975723</url>
    </required_header>
    <id_info>
      <org_study_id>AARG-22-928604</org_study_id>
      <nct_id>NCT05975723</nct_id>
    </id_info>
    <brief_title>MIND Diet and Cognitive Function in Adults With MCI</brief_title>
    <official_title>Effect of MIND Diet Intervention on Cognitive Function in Adults With Mild Cognitive Impairment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhejiang University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To examine the effects of a 1-year cluster-randomized controlled intervention of MIND diet on&#xD;
        cognitive function among 240 participants with mild cognitive function (MCI) aged 50 years&#xD;
        and above from 4 communities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The current study is a 1-year cluster-randomized controlled intervention trial designed to&#xD;
        examine whether the a localized modified Mediterranean-Dietary Approaches to Stop&#xD;
        Hypertension (DASH) dietary intervention for neurodegenerative delay (MIND) diet will improve&#xD;
        cognitive function among 240 participants with MCI from 4 communities. The modified MIND diet&#xD;
        recommends 11 brain healthy food groups (green leafy vegetables, dark red and yellow&#xD;
        vegetables, other vegetables, nuts, berries, beans, whole grains, seafood, poultry,&#xD;
        olive/tea-seed oil and green tea) and limits intake of 4 unhealthy food groups (red meat and&#xD;
        products, animal oil, pastries and sweets, and fried/fast food). This study will randomly&#xD;
        assign 240 MCI participants to two groups: A) MIND diet intervention group and B) control&#xD;
        group, and estimate the cognitive and biological impacts of the 1-year intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 26, 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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>
      <masking_description>Single (outcomes assessor)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Global Cognition measured by comprehensive Neuropsychological Test Battery (NTB)</measure>
      <time_frame>Up to one year</time_frame>
      <description>Global cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB). The z-score calculation will use the population mean and standard deviation, and a higher z-score indicates better cognitive performance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Domain-specific Cognition</measure>
      <time_frame>Up to one year</time_frame>
      <description>NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction. The z-score calculation will use the population mean and standard deviation, and a higher z-score indicates better cognitive performance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB)</measure>
      <time_frame>Up to one year</time_frame>
      <description>The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL)</measure>
      <time_frame>Up to one year</time_frame>
      <description>The Alzheimer's Disease Cooperative Study Activities of Daily Living-Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL) is scored from 0 to 53. Higher scores reflect better performance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>Up to one year</time_frame>
      <description>The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Montreal Cognitive Assessment (MoCA) score</measure>
      <time_frame>Up to one year</time_frame>
      <description>MoCA will be assessed to determine cognitive change.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in dietary behaviour measured using a food frequency questionnaire</measure>
      <time_frame>Up to one year</time_frame>
      <description>To evaluate the behavioural effect of dietary changes of the MIND diet intervention package.&#xD;
  Exploratory aim 1b: Changes in plasma levels of carotenoids, fatty acids, and vitamins (including folic acid). To evaluate the effect on nutritional biomarkers of the MIND diet intervention.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in depressive status measured using the Geriatric Depression Scale (GDS)</measure>
      <time_frame>Up to one year</time_frame>
      <description>To evaluate the effect on the depressive status of the MIND diet intervention. A higher GDS score indicates more severe depressive symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7)</measure>
      <time_frame>Up to one year</time_frame>
      <description>To evaluate the effect on the anxiety status of the MIND diet intervention. A higher GAD-7 score indicates more severe anxious symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in plasma metabolic profiles measured using metabolome analysis</measure>
      <time_frame>Up to one year</time_frame>
      <description>To evaluate the effect on plasma metabolites of the MIND diet intervention. We will assay the metabolome using liquid chromatography-mass spectrometry (LC-MS) and construct an overall metabolic score of the diet as the outcome.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in plasma inflammatory biomarkers</measure>
      <time_frame>Up to one year</time_frame>
      <description>To evaluate the effect on systematic inflammation of the MIND diet intervention. We will assay interferon-γ, Interleukin (IL)-10, IL-12p70, IL-13, IL-1β, IL-2, IL-4, IL-6, IL-8, Tumor Necrosis Factor alpha, and C-Reaction Protein and construct an overall plasma inflammatory biomarker score as the outcome.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in the intestinal microbiome</measure>
      <time_frame>Up to one year</time_frame>
      <description>To evaluate the effect on intestinal microbiome biodiversity and abundance in specific species in faecal samples of the MIND diet intervention. We will assay microbiome using 16-S ribosomal RNA (rRNA) sequencing and construct an overall intestinal microbiome score as the outcome.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Cognitive Function</condition>
    <condition>Cognitive Decline</condition>
    <arm_group>
      <arm_group_label>MIND diet intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the MIND diet group will receive an education program on a localized MIND diet for 1-year, and will be routinely followed up and given advice on other healthy lifestyles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in the control group will be routinely followed up and given general advice on healthy lifestyle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MIND diet education</intervention_name>
      <description>An intensified education program following a localized modified MIND diet for 1 year, which recommends 11 brain healthy food groups (green leafy vegetables, dark red and yellow vegetables, other vegetables, nuts, berries, beans, whole grains, seafood, poultry, olive/tea-seed oil and green tea) and limits intake of 4 unhealthy food groups (red meat and products, animal oil, pastries and sweets, and fried/fast food).</description>
      <arm_group_label>MIND diet intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Routine follow-up and general advice</intervention_name>
      <description>Routine follow-up administered by trained staff.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>MIND diet intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At risk of cognitive decline: cognitive performance at the mean level or slightly&#xD;
               lower than expected for age with no dementia (AD8&gt;=3 and/or 5-min MoCA &lt; 11)&#xD;
  &#xD;
            -  Free of physical disabilities that preclude participation in the study&#xD;
  &#xD;
            -  Willing to complete all study-related activities for 24 months&#xD;
  &#xD;
            -  Willing to be randomized to either intervention group&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Allergic to more than one type of food (nuts, berries, olive oil, or fish)&#xD;
  &#xD;
            -  Diagnosed of dementia, severe diabetes mellitus, cardiovascular disease, cancer,&#xD;
               thyroid disease, kidney disease, or liver disease&#xD;
  &#xD;
            -  Diagnosed of major depression or other neuropsychological diseases&#xD;
  &#xD;
            -  Severe loss of vision, hearing or communicative ability&#xD;
  &#xD;
            -  Substance abuse within 6 months or heavy alcohol consumption (&gt; 2 drinks/day for&#xD;
               women; &gt; 3 drinks/day for men).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Changzheng Yuan, ScD</last_name>
      <role>Study Chair</role>
      <affiliation>Zhejiang University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Changzheng Yuan, ScD</last_name>
      <phone>86-17326860291</phone>
      <email>chy478@zju.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xin Xu, PhD</last_name>
      <phone>86-13575760802</phone>
      <email>xuxinsummer@zju.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310058</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Changzheng Yuan, ScD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Chen H, Dhana K, Huang Y, Huang L, Tao Y, Liu X, Melo van Lent D, Zheng Y, Ascherio A, Willett W, Yuan C. Association of the Mediterranean Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet With the Risk of Dementia. JAMA Psychiatry. 2023 Jun 1;80(6):630-638. doi: 10.1001/jamapsychiatry.2023.0800.</citation>
      <PMID>37133875</PMID>
    </reference>
    <reference>
      <citation>Huang L, Tao Y, Chen H, Chen X, Shen J, Zhao C, Xu X, He M, Zhu D, Zhang R, Yang M, Zheng Y, Yuan C. Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Function and its Decline: A Prospective Study and Meta-analysis of Cohort Studies. Am J Clin Nutr. 2023 Jul;118(1):174-182. doi: 10.1016/j.ajcnut.2023.04.025. Epub 2023 Apr 25.</citation>
      <PMID>37105521</PMID>
    </reference>
    <reference>
      <citation>Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.</citation>
      <PMID>26086182</PMID>
    </reference>
    <reference>
      <citation>Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.</citation>
      <PMID>33434704</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhejiang University</investigator_affiliation>
      <investigator_full_name>Changzheng Yuan</investigator_full_name>
      <investigator_title>Professor</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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>When applicable, electronic data will be made available after trial completion.</ipd_description>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>When the final research data published, the data and other related resources would be shared in the Global Alzheimer's Association Interactive Network (GAAIN).</ipd_time_frame>
      <ipd_access_criteria>Review &amp; Approval by the Publications and Presentation Committee.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975723
  org study id: AARG-22-928604
  nct id: NCT05975723
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To examine the effects of a 1-year cluster-randomized controlled intervention of MIND diet on
        cognitive function among 240 participants with mild cognitive function (MCI) aged 50 years
        and above from 4 communities.
  The current study is a 1-year cluster-randomized controlled intervention trial designed to
        examine whether the a localized modified Mediterranean-Dietary Approaches to Stop
        Hypertension (DASH) dietary intervention for neurodegenerative delay (MIND) diet will improve
        cognitive function among 240 participants with MCI from 4 communities. The modified MIND diet
        recommends 11 brain healthy food groups (green leafy vegetables, dark red and yellow
        vegetables, other vegetables, nuts, berries, beans, whole grains, seafood, poultry,
        olive/tea-seed oil and green tea) and limits intake of 4 unhealthy food groups (red meat and
        products, animal oil, pastries and sweets, and fried/fast food). This study will randomly
        assign 240 MCI participants to two groups: A) MIND diet intervention group and B) control
        group, and estimate the cognitive and biological impacts of the 1-year intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: Single (outcomes assessor)
  measure: Change in Global Cognition measured by comprehensive Neuropsychological Test Battery (NTB)
  time frame: Up to one year
  description: Global cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB). The z-score calculation will use the population mean and standard deviation, and a higher z-score indicates better cognitive performance.
  measure: Change in Domain-specific Cognition
  time frame: Up to one year
  description: NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction. The z-score calculation will use the population mean and standard deviation, and a higher z-score indicates better cognitive performance.
  measure: Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
  time frame: Up to one year
  description: The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance.
  measure: Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL)
  time frame: Up to one year
  description: The Alzheimer's Disease Cooperative Study Activities of Daily Living-Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL) is scored from 0 to 53. Higher scores reflect better performance.
  measure: Change in Pittsburgh Sleep Quality Index (PSQI)
  time frame: Up to one year
  description: The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality.
  measure: Change in Montreal Cognitive Assessment (MoCA) score
  time frame: Up to one year
  description: MoCA will be assessed to determine cognitive change.
  measure: Change in dietary behaviour measured using a food frequency questionnaire
  time frame: Up to one year
  description: To evaluate the behavioural effect of dietary changes of the MIND diet intervention package.
  Exploratory aim 1b: Changes in plasma levels of carotenoids, fatty acids, and vitamins (including folic acid). To evaluate the effect on nutritional biomarkers of the MIND diet intervention.
  measure: Change in depressive status measured using the Geriatric Depression Scale (GDS)
  time frame: Up to one year
  description: To evaluate the effect on the depressive status of the MIND diet intervention. A higher GDS score indicates more severe depressive symptoms.
  measure: Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7)
  time frame: Up to one year
  description: To evaluate the effect on the anxiety status of the MIND diet intervention. A higher GAD-7 score indicates more severe anxious symptoms.
  measure: Changes in plasma metabolic profiles measured using metabolome analysis
  time frame: Up to one year
  description: To evaluate the effect on plasma metabolites of the MIND diet intervention. We will assay the metabolome using liquid chromatography-mass spectrometry (LC-MS) and construct an overall metabolic score of the diet as the outcome.
  measure: Changes in plasma inflammatory biomarkers
  time frame: Up to one year
  description: To evaluate the effect on systematic inflammation of the MIND diet intervention. We will assay interferon-γ, Interleukin (IL)-10, IL-12p70, IL-13, IL-1β, IL-2, IL-4, IL-6, IL-8, Tumor Necrosis Factor alpha, and C-Reaction Protein and construct an overall plasma inflammatory biomarker score as the outcome.
  measure: Changes in the intestinal microbiome
  time frame: Up to one year
  description: To evaluate the effect on intestinal microbiome biodiversity and abundance in specific species in faecal samples of the MIND diet intervention. We will assay microbiome using 16-S ribosomal RNA (rRNA) sequencing and construct an overall intestinal microbiome score as the outcome.
  arm group label: MIND diet intervention
  arm group type: Experimental
  description: Participants in the MIND diet group will receive an education program on a localized MIND diet for 1-year, and will be routinely followed up and given advice on other healthy lifestyles.
  arm group label: Control group
  arm group type: Active Comparator
  description: Participants in the control group will be routinely followed up and given general advice on healthy lifestyle.
  intervention type: Behavioral
  intervention name: MIND diet education
  description: An intensified education program following a localized modified MIND diet for 1 year, which recommends 11 brain healthy food groups (green leafy vegetables, dark red and yellow vegetables, other vegetables, nuts, berries, beans, whole grains, seafood, poultry, olive/tea-seed oil and green tea) and limits intake of 4 unhealthy food groups (red meat and products, animal oil, pastries and sweets, and fried/fast food).
  arm group label: MIND diet intervention
  intervention type: Behavioral
  intervention name: Routine follow-up and general advice
  description: Routine follow-up administered by trained staff.
  arm group label: Control group
  arm group label: MIND diet intervention
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Changzheng Yuan, ScD
  role: Study Chair
  affiliation: Zhejiang University
  last name: Changzheng Yuan, ScD
  phone: 86-17326860291
  email: chy478@zju.edu.cn
  last name: Xin Xu, PhD
  phone: 86-13575760802
  email: xuxinsummer@zju.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Chen H, Dhana K, Huang Y, Huang L, Tao Y, Liu X, Melo van Lent D, Zheng Y, Ascherio A, Willett W, Yuan C. Association of the Mediterranean Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet With the Risk of Dementia. JAMA Psychiatry. 2023 Jun 1;80(6):630-638. doi: 10.1001/jamapsychiatry.2023.0800.
  PMID: 37133875
  citation: Huang L, Tao Y, Chen H, Chen X, Shen J, Zhao C, Xu X, He M, Zhu D, Zhang R, Yang M, Zheng Y, Yuan C. Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Function and its Decline: A Prospective Study and Meta-analysis of Cohort Studies. Am J Clin Nutr. 2023 Jul;118(1):174-182. doi: 10.1016/j.ajcnut.2023.04.025. Epub 2023 Apr 25.
  PMID: 37105521
  citation: Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.
  PMID: 26086182
  citation: Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.
  PMID: 33434704
  responsible party type: Principal Investigator
  investigator affiliation: Zhejiang University
  investigator full name: Changzheng Yuan
  investigator title: Professor
  mesh term: Cognitive Dysfunction
  sharing ipd: Yes
  ipd description: When applicable, electronic data will be made available after trial completion.
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: When the final research data published, the data and other related resources would be shared in the Global Alzheimer's Association Interactive Network (GAAIN).
  ipd access criteria: Review & Approval by the Publications and Presentation Committee.