No registrations found.
ID
Source
Brief title
Health condition
Alzheimer's Disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cognitive Performance (ADAS-cog) during 24 weeks of intervention.
Secondary outcome
1. ADCS-ADL;
2. Cognitive test battery;
3. CDR-SOB;
4. Nutritional blood parameters;
5. Tolerance and safety.
All during 24 weeks of intervention.
Background summary
In this trial the Efficacy of intervention with a Food on cognitive
performance will be compared with a control product in Patients with Mild to Moderate Alzheimer's Disease using Alzheimer's Disease Medication.
Study objective
Intervention with the food under study has a positive effect on
cognitive performance in patients with mild to moderate Alzheimer's Disease.
Study design
0, 12 and 24 weeks.
Intervention
Duration of intervention: 24 weeks.
Intervention group: all participants in the intervention group will receive daily 125 ml of Souvenaid®. Souvenaid(r) is a 125ml (125kcal) once-a-day multi-nutrient drink.
Souvenaid® contains FortasynTM Connect [a specific combination of nutrients].
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
1. Diagnosis of probable AD according to the NINCDS-ADRDA criteria;
2. MMSE score 14-24;
3. Use of approved anti-AD medication on a stable dose for at least four months prior to baseline and anticipated stable use throughout the entire study period;
4. Age 50 years or older;
5. Availability of responsible caregiver;
6. Written informed consent of patient and caregiver.
Exclusion criteria
1. Diagnosis of significant neurological/ psychiatric disease other than AD;
2. Geriatric Depression Scale > 4 on 15-item scale;
3. 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).
4. Alcohol or drug abuse in opinion of the investigator.
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 | NL1603 |
| NTR-old | NTR1683 |
| Other | Danone Research – Centre for Specialised Nutrition : Protocol Number Alz.1.C/C |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |