Long-term Effects of Interventional Strategies to Prevent Cognitive Decline in Elderly. (MAPT-PLUS)
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|ClinicalTrials.gov Identifier: NCT01513252|
Recruitment Status : Unknown
Verified May 2018 by University Hospital, Toulouse.
Recruitment status was: Recruiting
First Posted : January 20, 2012
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Frail Elderly||Behavioral: Gröber and Buschke test||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Gröber and Buschke test
Behavioral: Gröber and Buschke test
spontaneous delayed recall score after a 5 years follow-up
- Gröber and Buschke test (spontaneous delayed recall score) [ Time Frame: 2 years ]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 ]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 ]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 ]Evaluation of the long-term impact of the MAPT interventions in terms of cost-effectiveness ratio by using a medico-economic data collection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513252
|Principal Investigator:||Bruno Vellas, MD||University Hospital, Toulouse|