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An observational study to evaluate the use of Souvenaid in real world daily clinical practice in patients with early Alzheimerís Disease.


- candidate number14376
- NTR NumberNTR3855
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-feb-2013
- Secondary IDsIRBN2012014 HdJ 1 METC IRBN te Nijmegen
- Public TitleAn observational study to evaluate the use of Souvenaid in real world daily clinical practice in patients with early Alzheimerís Disease.
- Scientific TitleAn observational study to evaluate the use of Souvenaid in real world daily clinical practice in patients with early Alzheimerís Disease.
- ACRONYMAWARE
- hypothesisThe primary endpoint is to evaluate the use of Souvenaid in patients with early AD in real world clinical practice by assessing the effect of Souvenaid on patientsí functioning on instrumental activities of daily living (IADL) as perceived by the caregiver.
- Healt Condition(s) or Problem(s) studiedAlzheimer's disease, Daily clinical practice, IADL, Souvenaid
- Inclusion criteria1. The patient is diagnosed with early AD as judged by the HCP (based on criteria used in the memory clinic);
2. The patient has a MMSE score of >20;
3. The HCP has decided to prescribe Souvenaid (up to 1 month ago);
4. A responsible caregiver of the patient is available;
5. The patient and caregiver are willing to give written approval of collecting anonymous data.
- Exclusion criteria1. The patient participates in any other study involving investigational or marketed products concomitantly or has participated in such a study within two weeks prior to entry into the study;
2. HCPís uncertainty about medical status, willingness or ability of the patient to comply with protocol requirements.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 20-feb-2013
- planned closingdate31-okt-2014
- Target number of participants315
- Interventions1 Souvenaid per day.
- Primary outcomeIADL (Amsterdam IADL Questionnaire).
- Secondary outcomeCompliance.
- Timepoints1. Baseline;
2. 6 months;
3. 12 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Karina Roozen
- CONTACT for SCIENTIFIC QUERIES Karina Roozen
- Sponsor/Initiator Nutricia Netherlands
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Netherlands
- PublicationsN/A
- Brief summaryCurrently recorded and published data regarding the use of Souvenaid result from controlled clinical trials in controlled patient populations. This observational study AWARE is developed to evaluate the use of Souvenaid in real world daily clinical practice in patients with early Alzheimerís Disease. The AWARE study is an open-label observational multi-centre study in real world daily clinical practice in The Netherlands.
- Main changes (audit trail)
- RECORD13-feb-2013 - 10-mrt-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl