|- 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.|
|- 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|
|- Type||2 or more arms, randomized|
|- 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;
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||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MSc Rico L. Wieggers|
|- CONTACT for SCIENTIFIC QUERIES||PhD M. Groenendijk|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|Danone Research B.V. |
|- Publications||Shah et al., J Nutr Health Aging, 2011;15; Suppl 1:S30.|
|- 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 - 14-mei-2013|