Clinical trial · Observational
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
NCT02249468CI-TRIAL-00026234terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stop the study for futility based on recommendation from Independent Data Committee.
Summary
Brief summary (as posted)
Difference in nutritional status between patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people in an Asian population
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitively Healthy People | — | UNRESOLVED | — |
| Mild and Moderate Alzheimer's Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Mild and Moderate Alzheimer's Disease
- label
- Cognitively intact healthy people
Primary outcomes (16)
- measure
- Uridine
- timeFrame
- 1 day
- description
- To look at nutritional Status in the blood
- measure
- Serum Phospholipids and Fatty Acid Profile
- timeFrame
- 1 day
- description
- Serum Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid To look at nutritional Status in the blood
- measure
- Red Blood Cell Phospholipids and fatty acid profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.