Dietary management of nutrient deficiencies with the medical food under study has a positive effect on memory performance in patients with mild Alzheimer’s Disease.
ID
Bron
Verkorte titel
Aandoening
Alzheimer’s Disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Memory performance (NTB) during 24 weeks of intervention.
Achtergrond van het onderzoek
In this trial the efficacy of intervention with a Medical Food on memory performance will be compared with a control product in Patients with mild Alzheimer’s Disease. The study is performed in 28 centers in the Netherlands, Belgium, Germany, Spain and Italy.
Doel van het onderzoek
Dietary management of nutrient deficiencies with the medical food under study has a positive effect on memory performance in patients with mild Alzheimer’s Disease.
Onderzoeksopzet
0, 12 and 24 weeks.
Onderzoeksproduct en/of interventie
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 Connect [a specific combination of nutrients];
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 FortasynTM Connect.
Publiek
PO Box 7005
M. Groenendijk
Wageningen 6700 CA
The Netherlands
+31 (0) 317 467 800
martine.groenendijk@danone.com
Wetenschappelijk
PO Box 7005
M. Groenendijk
Wageningen 6700 CA
The Netherlands
+31 (0) 317 467 800
martine.groenendijk@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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 | NL1863 |
| NTR-old | NTR1975 |
| Ander register | Danone Research – Centre for : Protocol Alz.1.C/D |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
De Waal et al. PLoS ONE. 2014 9(1): e86558.