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About
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.
Full 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:
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).
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Inclusion criteria
Subjects who meet the following criteria will be included in the MAPT PLUS study :
Exclusion criteria
Subjects who fulfill at least one of the following criteria will not be included in the MAPT PLUS study :
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1,028 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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