Long-term Effects of Interventional Strategies to Prevent Cognitive Decline in Elderly. (MAPT-PLUS)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A 2-years Extension Study of MAPT Trial : Evaluation of the Long Term Effects of Interventional Strategies to Prevent the Decline in Cognitive Functioning in Frail Older Adults|
- Gröber and Buschke test (spontaneous delayed recall score) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Assessment of cognitive and functional performances according to the spontaneous delayed recall score(Gröber and Buschke test)
- Cognitive and functional performance (Gröber and Buschke test-spontaneous delayed recall score) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Assessment of cognitive and functional performances by using the Gröber and Buschke test (spontaneous delayed recall score)at 5 years after the participation to the MAPT study.
- MRI test [ Time Frame: 2 years ] [ Designated as safety issue: No ]Evaluation of the long-term impact of MAPT study interventions on changes in markers of cerebral atrophy (overall brain volume of specific brain structures such as the hippocampus)
- Cost-effectiveness Evaluation [ Time Frame: 2 years ] [ Designated as safety issue: No ]Evaluation of the long-term impact of the MAPT interventions in terms of cost-effectiveness ratio by using a medico-economic data collection
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Gröber and Buschke test
Behavioral: Gröber and Buschke test
spontaneous delayed recall score after a 5 years follow-up
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513252
|UH Toulouse - La Grave||Recruiting|
|Toulouse, France, 31059|
|Contact: Bruno VELLAS, PR 33 5 61 77 64 25 firstname.lastname@example.org|
|Contact: Sophie GILLETTE, PHD 33 5 61 77 64 05 email@example.com|
|Principal Investigator:||Bruno Vellas, MD||University Hospital, Toulouse|