No registrations found.
ID
Source
Brief title
Health condition
Alzheimer¡¯s Disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Blood parameters: Nutritional blood parameters.
Background summary
In this trial the effect of intervention with a Medical Food on phospholipid metabolism in the brain will be compared with a control product in subjects with mild Alzheimer's disease dementia. The study is performed in 1 centre in the Netherlands.
Study objective
A 4 week intervention with the study product will affect MRS detectable brain metabolites related to phospholipid metabolism.
Study design
Baseline (day 0);
Visit 2 (day 28).
Intervention
Duration of intervention: 4 weeks.
Intervention group:
All participants in the intervention group will receive daily 125 ml of Souvenaid®. Souvenaid® is a 125ml (125kcal) once-a-day drink that contains the specific nutrient combination FortasynTM Connect.
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 FortasynTM Connect.
PO Box 7005
Rico L. Wieggers
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 800/+31 (0)646 237 293
rico.wieggers@danone.com
PO Box 7005
Rico L. Wieggers
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 800/+31 (0)646 237 293
rico.wieggers@danone.com
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3195 |
| NTR-old | NTR3346 |
| Other | Danone : Alz.1.C/H |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |