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

Terminated

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

• Registration Number: NCT02249468
• Lead Sponsor: Danone Nutricia Research

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-25
• Study Start: 2014-10
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 191

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore