| - candidate number | 6486 |
| - NTR Number | NTR1975 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 16-sep-2009 |
| - Secondary IDs | Protocol Alz.1.C/D Danone Research – Centre for |
| - 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. |
| - ACRONYM | Souvenir II |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Alzheimer |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-sep-2009 |
| - planned closingdate | 1-apr-2011 |
| - Target number of participants | 226 |
| - Interventions | 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 | 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. |
| - Timepoints | 0, 12 and 24 weeks. |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | PhD M. Groenendijk |
| - CONTACT for SCIENTIFIC QUERIES | MSc Rico L. Wieggers |
| - Sponsor/Initiator | Danone Research B.V. |
| - Funding (Source(s) of Monetary or Material Support) | Danone Research B.V. |
| - Publications | Scheltens et al. J Alzheimers Dis. 2012 31(1):225-36. |
| - Brief 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. |
| - Main changes (audit trail) | 01-Apr-2011: Secondary outcome added: exploratory MEG in a subset of subjects - NM |
| - RECORD | 16-sep-2009 - 20-mrt-2013 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl