Loading clinical trials...
Loading clinical trials...
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
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.
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).
Age
70 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Bordeaux
Bordeaux, France
CH Castres-Mazamet
Castres, France
CHRU Dijon
Dijon, France
CHIVA
Foix, France
LAVAUR
Lavaur, France
CHU Limoges
Limoges, France
Lyon-Sud Hospital
Lyon, France
Chg Montauban
Montauban, France
CHU Montpellier
Montpellier, France
Nice
Nice, France
Start Date
December 1, 2011
Primary Completion Date
April 15, 2016
Completion Date
July 20, 2020
Last Updated
June 3, 2024
1,028
ACTUAL participants
Gröber and Buschke test
BEHAVIORAL
Lead Sponsor
University Hospital, Toulouse
NCT06645847
NCT05875038
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions