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

Difference in nutritional status between patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people in an Asian population

Study Overview

• Status: Terminated
• Conditions: Mild and Moderate Alzheimer's Disease; Cognitively Healthy People

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 191

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people

Description

Inclusion Criteria:

• Age ≥ 50 years old
• Asian ethnicity
• Group 1: Cognitively intact healthy volunteers defined by Cumulative Illness Rating Scale for Geriatrics rating of ≤ 2 for all categories except for the category "psychiatric illness" which should have a rating of 0 and a CDR of 0 within 1 year prior to the visit.

OR

Group 2a: AD patients clinically diagnosed with mild AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-1

OR

Group 2b: AD patients clinically diagnosed with moderate AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-2

- Written informed consent provided according to local regulations.

Exclusion Criteria:

• Group 1 only: Current diagnosis of AD or other dementias according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al.,1984 )
• Group 2 only: Change in dose within 2 months prior to visit of AD medication (e.g. donepezil, rivastigmine, galantamine or memantine)

Group 1 and 2:

• Diagnosis of significant neurological disease (for Groups 2a and 2b: other than AD), including vascular dementia according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria, cerebral tumour, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, seizures, major depression, schizophrenia and other entities
• Use of vitamins supplements (only vitamins supplements C and D are allowed) for 3 months prior to the visit
• Use of vitamin B injections
• Alcohol or drug abuse as per investigator's judgement
• Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Mild and Moderate Alzheimer's Disease
Cognitively intact healthy people

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uridine	To look at nutritional Status in the blood	1 day
Serum Phospholipids and Fatty Acid Profile	Serum Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid To look at nutritional Status in the blood	1 day
Red Blood Cell Phospholipids and fatty acid profile	Red Blood Cell Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid To look at nutritional Status in the blood	1 day
Plasma polar lipid profile	Plasma polar lipid profile including several types of phospholipids and their specific species; and cholesterol-esters To look at nutritional Status in the blood	1 day
Choline	To look at nutritional Status in the blood	1 day
Homocysteine	To look at nutritional Status in the blood	1 day
Vitamin B6	To look at nutritional Status in the blood	1 day
Folate	To look at nutritional Status in the blood	1 day
Vitamin B12	To look at nutritional Status in the blood	1 day
Selenium	To look at nutritional Status in the blood	1 day
Vitamin E	To look at nutritional Status in the blood	1 day
Vitamin D	To look at nutritional Status in the blood	1 day
HbA1C (haemoglobin A1C )	Other blood parameters	1 day
Liver Function - Alanine Aminotransferase and Aspartate Aminotransferase	Other blood parameters	1 day
Kidney function - Creatinine	Other blood parameters	1 day
Inflammatory marker	C-reactive protein analysed using high sensitive C-reactive protein	1 day

Collaborators and Investigators

• Sponsor: Danone Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: August 27, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: Alz.1.C/O/0