| - candidate number | 5368 |
| - NTR Number | NTR1683 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 23-feb-2009 |
| - Secondary IDs | Protocol Number Alz.1.C/C Danone Research – Centre for Specialised Nutrition |
| - Public Title | S-Connect. |
| - Scientific Title | A Randomized Controlled Trial to Assess the Efficacy of a Food in Patients with Mild to Moderate Alzheimer's Disease using Alzheimer's Disease Medication. |
| - ACRONYM | S-Connect |
| - hypothesis | Intervention with the food under study has a positive effect on cognitive performance in patients with mild to moderate Alzheimer's Disease. |
| - Healt Condition(s) or Problem(s) studied | Alzheimer's disease |
| - Inclusion criteria | 1. Diagnosis of probable AD according to the NINCDS-ADRDA criteria; 2. MMSE score 14-24; 3. Use of approved anti-AD medication on a stable dose for at least four months prior to baseline and anticipated stable use throughout the entire study period; 4. Age 50 years or older; 5. Availability of responsible caregiver; 6. Written informed consent of patient and caregiver. |
| - Exclusion criteria | 1. Diagnosis of significant neurological/ psychiatric disease other than AD; 2. Geriatric Depression Scale > 4 on 15-item scale; 3. 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). 4. 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-mrt-2009 |
| - planned closingdate | 1-sep-2010 |
| - Target number of participants | 500 |
| - Interventions | Duration of intervention: 24 weeks.
Intervention group: all participants in the intervention group will receive daily 125 ml of Souvenaid®. Souvenaid(r) is a 125ml (125kcal) once-a-day multi-nutrient drink. Souvenaid® contains FortasynTM Connect [a specific combination of nutrients]. 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 | Cognitive Performance (ADAS-cog) during 24 weeks of intervention. |
| - Secondary outcome | 1. ADCS-ADL; 2. Cognitive test battery; 3. CDR-SOB; 4. Nutritional blood parameters; 5. Tolerance and safety. All during 24 weeks of intervention. |
| - Timepoints | 0, 12 and 24 weeks. |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | MSc Rico L. Wieggers |
| - CONTACT for SCIENTIFIC QUERIES | PhD M. Groenendijk |
| - Sponsor/Initiator | Danone Research B.V. |
| - Funding (Source(s) of Monetary or Material Support) | Danone Research B.V. |
| - Publications | N/A |
| - Brief summary | In this trial the Efficacy of intervention with a Food on cognitive performance will be compared with a control product in Patients with Mild to Moderate Alzheimer's Disease using Alzheimer's Disease Medication. |
| - Main changes (audit trail) | |
| - RECORD | 23-feb-2009 - 30-apr-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl