Cognitively Healthy People Clinical Trial
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
| Verified date | March 2017 |
| Source | PTSH Holding Singapore Pte Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Difference in nutritional status between patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people in an Asian population
| Status | Terminated |
| Enrollment | 191 |
| Est. completion date | November 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Singapore | National University Hospital | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| PTSH Holding Singapore Pte Ltd |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Uridine | To look at nutritional Status in the blood | 1 day | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Choline | To look at nutritional Status in the blood | 1 day | |
| Primary | Homocysteine | To look at nutritional Status in the blood | 1 day | |
| Primary | Vitamin B6 | To look at nutritional Status in the blood | 1 day | |
| Primary | Folate | To look at nutritional Status in the blood | 1 day | |
| Primary | Vitamin B12 | To look at nutritional Status in the blood | 1 day | |
| Primary | Selenium | To look at nutritional Status in the blood | 1 day | |
| Primary | Vitamin E | To look at nutritional Status in the blood | 1 day | |
| Primary | Vitamin D | To look at nutritional Status in the blood | 1 day | |
| Primary | HbA1C (haemoglobin A1C ) | Other blood parameters | 1 day | |
| Primary | Liver Function - Alanine Aminotransferase and Aspartate Aminotransferase | Other blood parameters | 1 day | |
| Primary | Kidney function - Creatinine | Other blood parameters | 1 day | |
| Primary | Inflammatory marker | C-reactive protein analysed using high sensitive C-reactive protein | 1 day |