|- candidate number||8558|
|- NTR Number||NTR2571|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-okt-2010|
|- Secondary IDs||Alz.1.C/F Danone Research - Centre for Specialised Nutrition|
|- Public Title||Souvenir II Open Label Extension study.|
|- Scientific Title||An open label extension study to evaluate long term use of a Food for Special Medical Purposes (FSMP) in patients with mild Alzheimer’s disease who completed the Souvenir II study.|
|- ACRONYM||Souvenir II OLE|
|- hypothesis||Collect long term data on compliance and safety of the study product in patients with mild Alzheimer’s disease who completed the Souvenir II study.|
|- Healt Condition(s) or Problem(s) studied||Alzheimer's disease|
|- Inclusion criteria||1. Completion of 24 week study visit Souvenir II study;|
2. Availability of responsible caregiver;
3. Written informed consent of subject and caregiver.
|- Exclusion criteria||1. Use of other investigational products;|
2. Alcohol or drug abuse in opinion of the investigator;
3. Investigator’s uncertainty about willingness, ability, or medical status of subject to comply with protocol requirements.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||15-jul-2010|
|- planned closingdate||31-dec-2011|
|- Target number of participants||200|
|- Interventions||Duration of intervention: 24 weeks.|
Intervention: All participants 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].
|- Primary outcome||Compliance and safety:|
1. Compliance as measured by the daily study product intake and product evaluation on taste and convenience;
2. Safety as measured by the number of (Serious) Adverse Events.
|- Secondary outcome||N/A|
|- Timepoints||V0 (screening & baseline);|
V1 (week 12);
V3 (week 24).
|- 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)
|Nutricia Research - Centre for Specialised Nutrition |
|- Publications||Scheltens et al., 2010.|
Olde Rikkert et al. J of Alzheimers Dis. 2015 44: 471–480.
|- Brief summary||In this trial the compliance and safety with a Medical Food will be monitored in Alzheimer’s Disease. The study is performed in 31 centers in the Netherlands, Belgium, Germany, Spain, Italy and France.|
|- Main changes (audit trail)|
|- RECORD||15-okt-2010 - 17-okt-2015|