No registrations found.
ID
Source
Brief title
Health condition
Alzheimer’s Disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Memory performance (NTB) during 24 weeks of intervention.
Secondary outcome
Cognition (NTB), DAD, EEG (exploratory MEG in a subset of subjects), Nutritional blood parameters, tolerance and safety during 24 weeks of intervention.
Exploratory MEG in a subset of subjects.
Background summary
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.
Study objective
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.
Study design
0, 12 and 24 weeks.
Intervention
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.
PO Box 7005
M. Groenendijk
Wageningen 6700 CA
The Netherlands
+31 (0) 317 467 800
martine.groenendijk@danone.com
PO Box 7005
M. Groenendijk
Wageningen 6700 CA
The Netherlands
+31 (0) 317 467 800
martine.groenendijk@danone.com
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
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 | NL1863 |
| NTR-old | NTR1975 |
| Other | Danone Research – Centre for : Protocol Alz.1.C/D |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
De Waal et al. PLoS ONE. 2014 9(1): e86558.