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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02249468
• Date of registration: 27/08/2014
• Prospective Registration: Yes
• Primary sponsor: PTSH Holding Singapore Pte Ltd
• Public 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
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 191
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02249468
• Study type: Observational
• Phase: N/A

Countries of recruitment

Singapore

Key inclusion & exclusion criteria

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



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cognitively Healthy People

Mild and Moderate Alzheimer's Disease

Primary Outcome(s)

Inflammatory marker [Time Frame: 1 day]

Vitamin D [Time Frame: 1 day]

HbA1C (haemoglobin A1C ) [Time Frame: 1 day]

Serum Phospholipids and Fatty Acid Profile [Time Frame: 1 day]

Vitamin E [Time Frame: 1 day]

Choline [Time Frame: 1 day]

Kidney function - Creatinine [Time Frame: 1 day]

Red Blood Cell Phospholipids and fatty acid profile [Time Frame: 1 day]

Folate [Time Frame: 1 day]

Liver Function - Alanine Aminotransferase and Aspartate Aminotransferase [Time Frame: 1 day]

Selenium [Time Frame: 1 day]

Vitamin B12 [Time Frame: 1 day]

Homocysteine [Time Frame: 1 day]

Plasma polar lipid profile [Time Frame: 1 day]

Uridine [Time Frame: 1 day]

Vitamin B6 [Time Frame: 1 day]

Secondary ID(s)

Alz.1.C/O/0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors