Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01513252 |
| Other study ID # |
RC31/11/231 |
| Secondary ID |
2011-A00764-37 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2011 |
| Est. completion date |
July 20, 2020 |
Study information
| Verified date |
May 2024 |
| Source |
University Hospital, Toulouse |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The MAPT PLUS study is a two-year extension of follow-up of the patients included in the MAPT
preventive study, after completion of the interventions. Subjects in the four groups of the
MAPT study will be prospectively followed. MAPT is a multicentre, randomised,
placebo-controlled study, using a 4-group design with 3 treatment groups (omega 3 alone,
multi-domain intervention alone, omega 3 plus multi-domain intervention, n=420 each) and a
placebo group (n=420). The MAPT PLUS study will be an extension of the MAPT study and
includes an annual follow-up for two years.
Description:
The MAPT PLUS study is a follow-up of subjects initially included in an interventional study.
The follow-up that we propose in this request for funding does not involve any intervention,
but aims to assess the long-term effect of the interventions previously carried out during
the three years of the MAPT study.
* Description of the interventions to which subjects are exposed during the first 3 years of
follow-up (MAPT study) :
In the MAPT study, subjects are randomized into 4 groups:
- V0137 CA group: 2 soft capsules of V0137 CA once a day (2 x 400 mg/day);
- Multi-domain intervention group (nutrition, physical activity, cognitive stimulation,
social activities) + placebo, 2 soft capsules once a day ;
- Multi-domain intervention group (nutrition, physical activity, cognitive stimulation,
social activities) + V0137 CA, 2 soft capsules once a day ;
- Placebo group: 2 soft capsules of placebo once a day. * Description of the multidomain
intervention : The multi-domain intervention consists of collective training sessions
and a yearly personalized preventive consultation which aims to detect risk factors
(sensory disturbances, difficulty in walking, nutritional disturbances, vascular risk
factors) and to set up management in collaboration with the general practitioner.
The collective sessions take place in groups of 6 to 8 subjects. In the first month, two
sessions a week are scheduled, and in the second month, one session a week. The first two
months correspond to the intensive programme. Each session comprises 1 hour of cognitive
training, 45 minutes of information on physical activity and 15 minutes of dietary advice.
From the third month, sessions are held monthly and aim to consolidate the key messages and
to stimulate adherence to the programme. The sessions are shorter (1 hour review of one of
the domains of the intensive programme). " Booster " sessions (2 hours) are delivered at 12
and 24 months after the first sessions of the intensive programme. Twenty-minute individual
interviews also take place every 6 months with the leader of the training sessions (6
interviews in the course of 3 years).
