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Souvenir II.


- candidate number6486
- NTR NumberNTR1975
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-sep-2009
- Secondary IDsProtocol Alz.1.C/D Danone Research – Centre for
- Public TitleSouvenir II.
- Scientific TitleA randomized controlled trial to assess the efficacy of a Food for Special Medical Purposes (FSMP) in patients with mild Alzheimer’s Disease.
- ACRONYMSouvenir II
- hypothesisDietary management of nutrient deficiencies with the medical food under study has a positive effect on memory performance in patients with mild Alzheimer’s Disease.
- Healt Condition(s) or Problem(s) studiedAlzheimer
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-apr-2011
- Target number of participants226
- Interventions1. 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 outcomeMemory performance (NTB) during 24 weeks of intervention.
- Secondary outcomeCognition (NTB), DAD, EEG (exploratory MEG in a subset of subjects), Nutritional blood parameters, tolerance and safety during 24 weeks of intervention.
- Timepoints0, 12 and 24 weeks.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESPhD M. Groenendijk
- CONTACT for SCIENTIFIC QUERIESMSc Rico L. Wieggers
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsScheltens et al. J Alzheimers Dis. 2012 31(1):225-36.
- Brief summaryIn 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.
- Main changes (audit trail)01-Apr-2011: Secondary outcome added: exploratory MEG in a subset of subjects - NM
- RECORD16-sep-2009 - 20-mrt-2013


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