|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR1975 |
|
Date of registration:
|
16/09/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Souvenir II.
|
|
Scientific title:
|
A randomized controlled trial to assess the efficacy of a Food for Special Medical Purposes (FSMP) in patients with mild Alzheimer?s Disease. - Souvenir II |
|
Date of first enrolment:
|
1/9/2009 |
|
Target sample size:
|
226 |
|
Recruitment status: |
complete |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1975 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
M.
Groenendijk |
|
Address:
|
Danone Research ? Centre for Specialised Nutrition
PO Box 7005
6700 CA
Wageningen
The Netherlands |
|
Telephone:
|
+31 (0) 317 467 800 |
|
Email:
|
martine.groenendijk@danone.com |
|
Affiliation:
|
|
|
|
Name:
|
Rico L.
Wieggers |
|
Address:
|
Danone Research ? Centre for Specialised Nutrition
PO Box 7005
6700 CA
Wageningen
The Netherlands |
|
Telephone:
|
+31 (0)317 467 800/+31 (0)646 237 293 |
|
Email:
|
rico.wieggers@danone.com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Alzheimer
|
|
Intervention(s)
|
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.
|
|
Primary Outcome(s)
|
|
Memory performance (NTB) during 24 weeks of intervention.
|
|
Secondary Outcome(s)
|
|
Cognition (NTB), DAD, EEG (exploratory MEG in a subset of subjects), Nutritional blood parameters, tolerance and safety during 24 weeks of intervention.
|
|
Secondary ID(s)
|
|
Protocol Alz.1.C/D
|
|
Source(s) of Monetary Support
|
|
Danone Research B.V.
|
|