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Frail ElderlyMAPT-PLUSNCT01513252

Long-term Effects of Interventional Strategies to Prevent Cognitive Decline in Elderly.

A study testing Gröber and Buschke test in people with Frail Elderly, run by University Hospital, Toulouse at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Frail Elderly
What is being tested?
Gröber and Buschke test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,028 participants
Where
13 sitesin 2 countries
Study dates
Dec 2011to 20 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 9Show fewer
  • 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.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

France12 sites

  • Bordeaux

    Bordeaux

  • CH Castres-Mazamet

    Castres

  • CHRU Dijon

    Dijon

  • CHIVA

    Foix

  • LAVAUR

    Lavaur

  • CHU Limoges

    Limoges

  • Lyon-Sud Hospital

    Lyon

  • Chg Montauban

    Montauban, 82000

  • CHU Montpellier

    Montpellier

  • Nice

    Nice

  • Tarbes

    Tarbes

  • UH Toulouse - La Grave

    Toulouse, 31059

Other trials in France

Monaco1 site

  • CH Princesse Grâce

    Monaco

Other trials in Monaco

About this study

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

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.

Read the 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).

Conditions
Frail Elderly
Being tested
Gröber and Buschke test
Keywords
Cognitive decline, prevention, omega-3 fatty acids, nutrition exercise, cognitive training, social activities, frailty
Medical subject headings
Cognitive Dysfunction, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gröber and Buschke testBehavioural

    spontaneous delayed recall score after a 5 years follow-up

Study groups in NCT01513252
Study groupRoleWhat they receive
1ExperimentalGröber and Buschke test
Receives: Behavioral: Gröber and Buschke test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gröber and Buschke test (spontaneous delayed recall score)

    Assessment of cognitive and functional performances according to the spontaneous delayed recall score(Gröber and Buschke test)

    Measured: 2 years

  2. Cognitive and functional performance (Gröber and Buschke test-spontaneous delayed recall score)

    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.

    Measured: 2 years

Secondary outcomes (2)

  1. MRI test

    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)

    Measured: 2 years

  2. Cost-effectiveness Evaluation

    Evaluation of the long-term impact of the MAPT interventions in terms of cost-effectiveness ratio by using a medico-economic data collection

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2012 (estimated)
  2. Study startDec 2011
  3. Primary completion15 Apr 2016
  4. Study completion20 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,028 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513252
Sponsor's protocol ID
RC31/11/231
Other IDs
2011-A00764-37
Acronym
MAPT-PLUS
Status last verified
May 2024
First submitted
30 Dec 2011
Last updated
3 Jun 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Delrieu J, Vellas B, Guyonnet S, Cantet C, Ovod V, Li Y, Bollinger J, Bateman R, Andrieu S; MAPT/DSA group. Cognitive impact of multidomain intervention and omega 3 according to blood Abeta42/40 ratio: a subgroup analysis from the randomized MAPT trial. Alzheimers Res Ther. 2023 Oct 23;15(1):183. doi: 10.1186/s13195-023-01325-3.

    PubMed 37872582

  • Takano E, Maltais M, Kondo I, Rolland Y; MAPT/DSA group. Bidirectional relationship between depressive symptoms and physical performance in community-dwelling older people with subjective memory complaints. Eur Geriatr Med. 2021 Oct;12(5):973-980. doi: 10.1007/s41999-021-00473-9. Epub 2021 Mar 5.

    PubMed 33666880

  • Delrieu J, Voisin T, Saint-Aubert L, Carrie I, Cantet C, Vellas B, Payoux P, Andrieu S. The impact of a multi-domain intervention on cerebral glucose metabolism: analysis from the randomized ancillary FDG PET MAPT trial. Alzheimers Res Ther. 2020 Oct 19;12(1):134. doi: 10.1186/s13195-020-00683-6.

    PubMed 33076983

  • Delrieu J, Payoux P, Carrie I, Cantet C, Weiner M, Vellas B, Andrieu S. Multidomain intervention and/or omega-3 in nondemented elderly subjects according to amyloid status. Alzheimers Dement. 2019 Nov;15(11):1392-1401. doi: 10.1016/j.jalz.2019.07.008. Epub 2019 Sep 23.

    PubMed 31558366

  • Pothier K, de Souto Barreto P, Maltais M, Rolland Y, Vellas B. Shifting from Declines to Improvements: Associations between a Meaningful Walking Speed Change and Cognitive Evolution over Three Years in Older Adults. J Nutr Health Aging. 2018;22(10):1183-1188. doi: 10.1007/s12603-018-1059-8.

    PubMed 30498824

  • Lilamand M, Cesari M, Cantet C, Payoux P, Andrieu S, Vellas B; the MAPT/DSA study group. Relationship Between Brain Amyloid Deposition and Instrumental Activities of Daily Living in Older Adults: A Longitudinal Study from the Multidomain Alzheimer Prevention Trial. J Am Geriatr Soc. 2018 Oct;66(10):1940-1947. doi: 10.1111/jgs.15497. Epub 2018 Sep 12.

    PubMed 30207586

Questions about this trial

What is this clinical trial studying?

A study testing Gröber and Buschke test in people with Frail Elderly, run by University Hospital, Toulouse at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gröber and Buschke test (spontaneous delayed recall score) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01513252, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.

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