NCT01513252

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,028

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2016

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

4.4 years

First QC Date

December 30, 2011

Last Update Submit

May 31, 2024

Conditions

Frail Elderly

Keywords

Cognitive declinepreventionomega-3 fatty acidsnutrition exercisecognitive trainingsocial activitiesfrailty

Outcome Measures

Primary Outcomes (2)

  • 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)

    2 years

  • 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.

    2 years

Secondary Outcomes (2)

  • MRI test

    2 years

  • Cost-effectiveness Evaluation

    2 years

Study Arms (1)

1

EXPERIMENTAL

Gröber and Buschke test

Behavioral: Gröber and Buschke test

Interventions

Gröber and Buschke testBEHAVIORAL

spontaneous delayed recall score after a 5 years follow-up

1

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Bordeaux

Bordeaux, France

Location

CH Castres-Mazamet

Castres, France

Location

CHRU Dijon

Dijon, France

Location

CHIVA

Foix, France

Location

LAVAUR

Lavaur, France

Location

CHU Limoges

Limoges, France

Location

Lyon-Sud Hospital

Lyon, France

Location

Chg Montauban

Montauban, 82000, France

Location

CHU Montpellier

Montpellier, France

Location

Nice

Nice, France

Location

Tarbes

Tarbes, France

Location

UH Toulouse - La Grave

Toulouse, 31059, France

Location

CH Princesse Grâce

Monaco, Monaco

Location

Related Publications (6)

  • 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.

    PMID: 37872582DERIVED

  • 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.

    PMID: 33666880DERIVED

  • 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.

    PMID: 33076983DERIVED

  • 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.

    PMID: 31558366DERIVED

  • 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.

    PMID: 30498824DERIVED

  • 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.

    PMID: 30207586DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionFrailty

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bruno Vellas, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2011

First Posted

January 20, 2012

Study Start

December 1, 2011

Primary Completion

April 15, 2016

Study Completion

July 20, 2020

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations

FR(12)MO(1)