Clinical trial NCT02249468: 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: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mild and Moderate Alzheimer's Disease
Cognitively Healthy People
Lead sponsor: Danone Nutricia Research
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 191
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people

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

Eligibility 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

Primary outcomes:
measure: Uridine
timeFrame: 1 day
measure: Serum Phospholipids and Fatty Acid Profile
timeFrame: 1 day
measure: Red Blood Cell Phospholipids and fatty acid profile
timeFrame: 1 day
measure: Plasma polar lipid profile
timeFrame: 1 day
measure: Choline
timeFrame: 1 day
measure: Homocysteine
timeFrame: 1 day
measure: Vitamin B6
timeFrame: 1 day
measure: Folate
timeFrame: 1 day
measure: Vitamin B12
timeFrame: 1 day
measure: Selenium
timeFrame: 1 day
measure: Vitamin E
timeFrame: 1 day
measure: Vitamin D
timeFrame: 1 day
measure: HbA1C (haemoglobin A1C )
timeFrame: 1 day
measure: Liver Function - Alanine Aminotransferase and Aspartate Aminotransferase
timeFrame: 1 day
measure: Kidney function - Creatinine
timeFrame: 1 day
measure: Inflammatory marker
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References: