Long-term Effects of Interventional Strategies to Prevent Cognitive Decline in Elderly. (MAPT-PLUS)

May 31, 2024 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

1028

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • BORDEAUX
      • Castres, France
        • CH Castres-Mazamet
      • Dijon, France
        • CHRU Dijon
      • Foix, France
        • CHIVA
      • Lavaur, France
        • LAVAUR
      • Limoges, France
        • CHU Limoges
      • Lyon, France
        • Lyon-Sud Hospital
      • Montauban, France, 82000
        • Chg Montauban
      • Montpellier, France
        • CHU Montpellier
      • Nice, France
        • NICE
      • Tarbes, France
        • Tarbes
      • Toulouse, France, 31059
        • UH Toulouse - La Grave
  • Monaco
      • Monaco, Monaco
        • CH Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Subjects who meet the following criteria will be included in the MAPT PLUS study :

  • frail elderly subjects participating in the MAPT study and still followed at 3 years,
  • subjects capable of understanding the protocol, complying with its requirements and attending the follow-up visits proposed as part of the extended phase of the MAPT study,
  • subjects capable of giving their written informed consent and complying with the requirements of the study,
  • subjects covered by a health insurance system.

Exclusion Criteria:

Subjects who fulfill at least one of the following criteria will not be included in the MAPT PLUS study :

  • known presence of dementia or Alzheimer's disease (DSM IV criteria) diagnosed during the MAPT follow-up,
  • known presence of severe diseases that are life-threatening in the short term,
  • visual or hearing impairments that are incompatible with performance and/or interpretation of the neuropsychological tests,
  • history and/or presence of any disorder (severe depression or generalized anxiety) which, according to the investigator, is likely to interfere with the results of the study or to expose the subject to a supplementary risk,
  • participation in another clinical study during the period of the present study,
  • subjects who have refused cognitive evaluation during the MAPT follow-up,
  • subjects deprived of their freedom by administrative or judicial decision, or under guardianship,
  • with regard to performance of MRI: presence of a pacemaker or metallic materials, claustrophobia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Gröber and Buschke test
Behavioral: Gröber and Buschke test
spontaneous delayed recall score after a 5 years follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Bruno Vellas, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

April 15, 2016

Study Completion (Actual)

July 20, 2020

Study Registration Dates

First Submitted

December 30, 2011

First Submitted That Met QC Criteria

January 16, 2012

First Posted (Estimated)

January 20, 2012

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/11/231
  • 2011-A00764-37 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Frail Elderly

Clinical Trials on Gröber and Buschke test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe