A 4 week intervention with the study product will affect MRS detectable brain metabolites related to phospholipid metabolism.
ID
Bron
Verkorte titel
Aandoening
Alzheimer¡¯s Disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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;<br>
2. 1H-MRS outcome parameters: Absolute and relative brain tissue levels of several metabolites.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
A 4 week intervention with the study product will affect MRS detectable brain metabolites related to phospholipid metabolism.
Onderzoeksopzet
Baseline (day 0);
Visit 2 (day 28).
Onderzoeksproduct en/of interventie
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.
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)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
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 | NL3195 |
| NTR-old | NTR3346 |
| Ander register | Danone : Alz.1.C/H |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |