Intervention with the food under study has a positive effect on cognitive performance in patients with mild to moderate Alzheimer's Disease.
ID
Bron
Verkorte titel
Aandoening
Alzheimer's Disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Cognitive Performance (ADAS-cog) during 24 weeks of intervention.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Intervention with the food under study has a positive effect on
cognitive performance in patients with mild to moderate Alzheimer's Disease.
Onderzoeksopzet
0, 12 and 24 weeks.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1603 |
| NTR-old | NTR1683 |
| Ander register | Danone Research – Centre for Specialised Nutrition : Protocol Number Alz.1.C/C |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |