Alzheimer¡¯s Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Main inclusion criteria: 1. Diagnosis of probable or possible AD with evidence of the pathophysiological process according to the recently revised criteria; 2. MMSE score ≥ 20; 3. MRI or CT scan within two years before baseline showing no evidence of any other potential cause of dementia other than AD; 4. Age ≥ 50 years; 5. Availability of responsible caregiver; 6. Written informed consent of patient and caregiver.
Exclusion criteria
Exclusion criteria: Main exclusion criteria: 1. Diagnosis of significant neurological and/or psychiatric disease other than AD; 2. History or expected need during the study of approved anti-AD medication; 3. Geriatric Depression Scale > 6 on 15-item scale; 4. Hachinski Ischemia Scale score > 5; 5. Use within two months prior to baseline of: A. Omega-3 fatty acid containing supplements; B. Oily fish (when consumed more than twice a week). 6. Alcohol or drug abuse in opinion of the investigator; 7. Contraindications to magnetic resonance imaging (MRI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The main 31P-MRS outcome parameters are the total level of Phosphomonoesters (PME), total level of Phosphodiesters (PDE), and the ratio between PME and PDE; 2. 1H-MRS outcome parameters: Absolute and relative brain tissue levels of several metabolites. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood parameters: Nutritional blood parameters. | — |
Contacts
Danone Research – Centre for Specialised Nutrition PO Box 7005