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Souvenir II Open Label Extension study.


- candidate number8558
- NTR NumberNTR2571
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-okt-2010
- Secondary IDsAlz.1.C/F Danone Research - Centre for Specialised Nutrition
- Public TitleSouvenir II Open Label Extension study.
- Scientific TitleAn 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.
- ACRONYMSouvenir II OLE
- hypothesisCollect 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) studiedAlzheimer's disease
- Inclusion criteria1. Completion of 24 week study visit Souvenir II study;
2. Availability of responsible caregiver;
3. Written informed consent of subject and caregiver.
- Exclusion criteria1. 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 receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-jul-2010
- planned closingdate31-dec-2011
- Target number of participants200
- InterventionsDuration 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 outcomeCompliance 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 outcomeN/A
- TimepointsV0 (screening & baseline);
V1 (week 12);
V3 (week 24).
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc Rico L. Wieggers
- CONTACT for SCIENTIFIC QUERIESPhD M. Groenendijk
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsScheltens et al., 2010.
Olde Rikkert et al. J of Alzheimers Dis. 2015 44: 471–480.
- Brief summaryIn 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)
- RECORD15-okt-2010 - 17-okt-2015


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