Alzheimer’s Disease
Conditions
Interventions
1. Duration of intervention: 24 weeks
2. Intervention group: All participants in the intervention group will receive daily 125 ml of Souvenaid®. Souvenaid® is a 125ml (125kcal) once-a-day milk-based drink. Souvenaid® contains FortasynTM C
3. Control group: All participants in the control group will receive daily 125 ml of a control product. The control product is iso-caloric, similar in flavour, appearance, and composition without Fort
Sponsors
Danone Research, Centre For Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of probable AD according to the NINCDS-ADRDA criteria; 2. MRI or CT scan within two years before baseline showing no evidence of any other potential cause of dementia other than AD; 3. MMSE ≥ 20; 4. Age ≥ 50 years; 5. Written informed consent; 6. Availability of a responsible caregiver.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of significant neurological disease other than AD; 2. Use within 3 months prior to baseline, or expected need during the study of approved anti-AD medication; 3. Geriatric Depression Scale> 4 on 15-item scale; 4. 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); C. Alcohol or drug abuse in opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Memory performance (NTB) during 24 weeks of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognition (NTB), DAD, EEG (exploratory MEG in a subset of subjects), Nutritional blood parameters, tolerance and safety during 24 weeks of intervention. Exploratory MEG in a subset of subjects. | — |
Contacts
Public ContactM. Groenendijk
Danone Research – Centre for Specialised Nutrition PO Box 7005
Outcome results
None listed