No registrations found.
ID
Source
Brief title
Health condition
Alzheimer’s Disease
Sponsors and support
Intervention
Outcome measures
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
Background 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.
Study objective
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.
Study design
V0 (screening & baseline);
V1 (week 12);
V3 (week 24).
Intervention
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].
PO Box 7005
Rico L. Wieggers
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 800/+31 (0)646 237 293
rico.wieggers@danone.com
PO Box 7005
Rico L. Wieggers
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 800/+31 (0)646 237 293
rico.wieggers@danone.com
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.
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 | NL2456 |
| NTR-old | NTR2571 |
| Other | Danone Research - Centre for Specialised Nutrition : Alz.1.C/F |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
Olde Rikkert et al. J of Alzheimers Dis. 2015 44: 471–480.