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.
ID
Bron
Verkorte titel
Aandoening
Alzheimer’s Disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Compliance and safety:<br>
1. Compliance as measured by the daily study product intake and product evaluation on taste and convenience;<br>
2. Safety as measured by the number of (Serious) Adverse Events.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
V0 (screening & baseline);
V1 (week 12);
V3 (week 24).
Onderzoeksproduct en/of interventie
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].
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Completion of 24 week study visit Souvenir II study;
2. Availability of responsible caregiver;
3. Written informed consent of subject and caregiver.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2456 |
| NTR-old | NTR2571 |
| Ander register | Danone Research - Centre for Specialised Nutrition : Alz.1.C/F |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
Olde Rikkert et al. J of Alzheimers Dis. 2015 44: 471–480.