<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/NCT02249468</url>
  </required_header>
  <id_info>
    <org_study_id>Alz.1.C/O/0</org_study_id>
    <nct_id>NCT02249468</nct_id>
  </id_info>
  <brief_title>An Exploratory Study to Compare the Differences in Nutritional Status Between Patients With Mild and Moderate Alzheimer's Disease (AD) and Cognitively Intact Healthy People in an Asian Population</brief_title>
  <official_title>An Exploratory Study to Compare the Differences in Nutritional Status Between Patients With Mild and Moderate Alzheimer's Disease (AD) and Cognitively Intact Healthy People in an Asian Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danone Nutricia Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danone Nutricia Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Difference in nutritional status between patients with mild and moderate Alzheimer's Disease&#xD;
      (AD) and cognitively intact healthy people in an Asian population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of the current Asian nutritional status study is to get more insight into&#xD;
      the nutritional status of AD patients in an Asian population in Asia. Plasma levels of&#xD;
      several micronutrients and the fatty acid profile will be compared between patients with mild&#xD;
      and moderate AD and cognitively intact healthy controls in an Asian population&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Stop the study for futility based on recommendation from Independent Data Committee.&#xD;
  </why_stopped>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Uridine</measure>
    <time_frame>1 day</time_frame>
    <description>To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Phospholipids and Fatty Acid Profile</measure>
    <time_frame>1 day</time_frame>
    <description>Serum Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid&#xD;
To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Red Blood Cell Phospholipids and fatty acid profile</measure>
    <time_frame>1 day</time_frame>
    <description>Red Blood Cell Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid&#xD;
To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma polar lipid profile</measure>
    <time_frame>1 day</time_frame>
    <description>Plasma polar lipid profile including several types of phospholipids and their specific species; and cholesterol-esters&#xD;
To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Choline</measure>
    <time_frame>1 day</time_frame>
    <description>To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Homocysteine</measure>
    <time_frame>1 day</time_frame>
    <description>To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin B6</measure>
    <time_frame>1 day</time_frame>
    <description>To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Folate</measure>
    <time_frame>1 day</time_frame>
    <description>To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin B12</measure>
    <time_frame>1 day</time_frame>
    <description>To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Selenium</measure>
    <time_frame>1 day</time_frame>
    <description>To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin E</measure>
    <time_frame>1 day</time_frame>
    <description>To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin D</measure>
    <time_frame>1 day</time_frame>
    <description>To look at nutritional Status in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HbA1C (haemoglobin A1C )</measure>
    <time_frame>1 day</time_frame>
    <description>Other blood parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver Function - Alanine Aminotransferase and Aspartate Aminotransferase</measure>
    <time_frame>1 day</time_frame>
    <description>Other blood parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kidney function - Creatinine</measure>
    <time_frame>1 day</time_frame>
    <description>Other blood parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammatory marker</measure>
    <time_frame>1 day</time_frame>
    <description>C-reactive protein analysed using high sensitive C-reactive protein</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">191</enrollment>
  <condition>Mild and Moderate Alzheimer's Disease</condition>
  <condition>Cognitively Healthy People</condition>
  <arm_group>
    <arm_group_label>Mild and Moderate Alzheimer's Disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitively intact healthy people</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy&#xD;
        people&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 50 years old&#xD;
&#xD;
          -  Asian ethnicity&#xD;
&#xD;
          -  Group 1: Cognitively intact healthy volunteers defined by Cumulative Illness Rating&#xD;
             Scale for Geriatrics rating of ≤ 2 for all categories except for the category&#xD;
             &quot;psychiatric illness&quot; which should have a rating of 0 and a CDR of 0 within 1 year&#xD;
             prior to the visit.&#xD;
&#xD;
        OR&#xD;
&#xD;
        Group 2a: AD patients clinically diagnosed with mild AD (according to the National&#xD;
        Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and&#xD;
        Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-1&#xD;
&#xD;
        OR&#xD;
&#xD;
        Group 2b: AD patients clinically diagnosed with moderate AD (according to the National&#xD;
        Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and&#xD;
        Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-2&#xD;
&#xD;
        - Written informed consent provided according to local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Group 1 only: Current diagnosis of AD or other dementias according to National&#xD;
             Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease&#xD;
             and Related Disorders criteria (McKhann et al.,1984 )&#xD;
&#xD;
          -  Group 2 only: Change in dose within 2 months prior to visit of AD medication (e.g.&#xD;
             donepezil, rivastigmine, galantamine or memantine)&#xD;
&#xD;
        Group 1 and 2:&#xD;
&#xD;
          -  Diagnosis of significant neurological disease (for Groups 2a and 2b: other than AD),&#xD;
             including vascular dementia according to National Institute of Neurological and&#xD;
             Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders&#xD;
             criteria, cerebral tumour, Huntington's Disease, Parkinson's Disease, normal pressure&#xD;
             hydrocephalus, seizures, major depression, schizophrenia and other entities&#xD;
&#xD;
          -  Use of vitamins supplements (only vitamins supplements C and D are allowed) for 3&#xD;
             months prior to the visit&#xD;
&#xD;
          -  Use of vitamin B injections&#xD;
&#xD;
          -  Alcohol or drug abuse as per investigator's judgement&#xD;
&#xD;
          -  Investigator's uncertainty about the willingness or ability of the patient to comply&#xD;
             with the protocol requirements&#xD;
&#xD;
          -  Participation in any other studies involving investigational or marketed products&#xD;
             concomitantly or within two weeks prior to entry into the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 2, 2017</last_update_submitted>
  <last_update_submitted_qc>March 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT02249468
org study id: Alz.1.C/O/0
nct id: NCT02249468
lead sponsor: 
has dmc: No
Difference in nutritional status between patients with mild and moderate Alzheimer's Disease
      (AD) and cognitively intact healthy people in an Asian population
The main objective of the current Asian nutritional status study is to get more insight into
      the nutritional status of AD patients in an Asian population in Asia. Plasma levels of
      several micronutrients and the fatty acid profile will be compared between patients with mild
      and moderate AD and cognitively intact healthy controls in an Asian population
observational model: Case-Control
time perspective: Prospective
measure: Uridine
time frame: 1 day
description: To look at nutritional Status in the blood
measure: Serum Phospholipids and Fatty Acid Profile
time frame: 1 day
description: Serum Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid
To look at nutritional Status in the blood
measure: Red Blood Cell Phospholipids and fatty acid profile
time frame: 1 day
description: Red Blood Cell Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid
To look at nutritional Status in the blood
measure: Plasma polar lipid profile
time frame: 1 day
description: Plasma polar lipid profile including several types of phospholipids and their specific species; and cholesterol-esters
To look at nutritional Status in the blood
measure: Choline
time frame: 1 day
description: To look at nutritional Status in the blood
measure: Homocysteine
time frame: 1 day
description: To look at nutritional Status in the blood
measure: Vitamin B6
time frame: 1 day
description: To look at nutritional Status in the blood
measure: Folate
time frame: 1 day
description: To look at nutritional Status in the blood
measure: Vitamin B12
time frame: 1 day
description: To look at nutritional Status in the blood
measure: Selenium
time frame: 1 day
description: To look at nutritional Status in the blood
measure: Vitamin E
time frame: 1 day
description: To look at nutritional Status in the blood
measure: Vitamin D
time frame: 1 day
description: To look at nutritional Status in the blood
measure: HbA1C (haemoglobin A1C )
time frame: 1 day
description: Other blood parameters
measure: Liver Function - Alanine Aminotransferase and Aspartate Aminotransferase
time frame: 1 day
description: Other blood parameters
measure: Kidney function - Creatinine
time frame: 1 day
description: Other blood parameters
measure: Inflammatory marker
time frame: 1 day
description: C-reactive protein analysed using high sensitive C-reactive protein
arm group label: Mild and Moderate Alzheimer's Disease
arm group label: Cognitively intact healthy people
Plasma samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Alzheimer Disease