No registrations found.
ID
Source
Brief title
Health condition
early Alzheimer's Disease
Souvenaid
daily clinical practice
IADL
Sponsors and support
Zoetermeer, The Netherlands
Zoetermeer, The Netherlands
Intervention
Outcome measures
Primary outcome
IADL (Amsterdam IADL Questionnaire).
Secondary outcome
Compliance.
Background summary
Currently 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 Alzheimer’s Disease. The AWARE study is an open-label observational multi-centre study in real world daily clinical practice in The Netherlands.
Study objective
The 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 patients’ functioning on instrumental activities of daily living (IADL) as perceived by the caregiver.
Study design
1. Baseline;
2. 6 months;
3. 12 months.
Intervention
1 Souvenaid per day.
Postbus 445
Karina Roozen
Zoetermeer 2700 AK
The Netherlands
+31 (0)6 55860755
karina.roozen@nutricia.com
Postbus 445
Karina Roozen
Zoetermeer 2700 AK
The Netherlands
+31 (0)6 55860755
karina.roozen@nutricia.com
Inclusion criteria
1. 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 criteria
1. 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. HCP’s uncertainty about medical status, willingness or ability of the patient to comply with protocol requirements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3685 |
| NTR-old | NTR3855 |
| Other | METC IRBN te Nijmegen : IRBN2012014 HdJ 1 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |