Omega-3 Fatty Acids and/or Multi-domain Intervention in the Prevention of Age-related Cognitive Decline (MAPT)

April 16, 2015 updated by: University Hospital, Toulouse

Assessment of the Efficacy of Omega-3 Fatty Acids Supplementation, Multi-domain Intervention or Their Combination on the Change of Cognitive Functions in Frail Elderly Subjects

Epidemiological and fundamental research carried out in recent years has highlighted the role played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing age and Alzheimer's disease. In addition, it has been recognized for some years, following several convergent studies on the prevention of cognitive decline, that nutrition, physical exercise, cognitive training and social activities play a significant role in the maintenance of cognitive faculties. At present, there are a number of epidemiological arguments in favour of a protective role of each of these factors taken in isolation. It can be postulated that a multi-domain intervention may potentiate the protective role of omega-3 fatty acids.

The main objective of this study is to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise, cognitive stimulation, social activities), or their combination on the change of cognitive functions in frail elderly subjects aged of 70 years and older over 3 years.

Secondary objectives:

  • To assess the efficacy of each treatment strategy on the change of functional capacities and the prevention of dependency,
  • To study the long-term safety and tolerability of V0137,
  • To study compliance and adhesion to the multi-domain intervention programme,

Ancillary studies :

To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : : impact of multidomain intervention on brain metabolism (FDG-PET))

  • To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain intervention ) of MAPT study on brain atrophy (MRI),
  • To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans (MAPT AV45),
  • To determine if sleep disorders at early stage of Alzheimer 's disease could be predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)
  • To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA scans (MAPT-DXA)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-centre , randomised, placebo-controlled study in parallel groups in 1680 frail elderly subjects over the age of 70 years, living at home, monitored for a period of 3 years. The subjects will be randomised into one of the following 4 groups:

  • Omega-3 group: 800 mg/day of docosahexaenoic acid (V0137CA nutritional supplement)
  • Omega-3 + multi-domain intervention group: 800 mg/day of docosahexaenoic acid ( V0137CA)
  • Placebo + multi-domain intervention group
  • Placebo group The multi-domain intervention includes training / information sessions in the following 4 areas: nutrition, physical activity, cognitive training and social activities, and preventive consultations.

Selected subjects will present at least one of the following frailty criteria:

  • Loss of one Instrumental Activity Daily Living (IADL)
  • Subjective memory complaints to a physician
  • Slow walking speed. Follow-up visits will occur every six months for 3 years for both dispensing of supplement and compliance (months 6, 12, 18, 24, 30 and 36) and neuropsychological and functional assessment (months 6, 12, 24, 36).

Study Type

Interventional

Enrollment (Actual)

1680

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, 33000
        • University Hospital Bordeaux
      • Castres, France, 81108
        • Regional Hospital
      • Dijon, France, 21033
        • University Hospital of Dijon
      • Foix, France, 09017
        • Regional Hospital
      • Lavaur, France, 81500
        • Regional Hospital
      • Limoges, France, 87000
        • University Hospital Limoges
      • Lyon, France, 69495
        • UH of LYON SUD
      • Montauban, France, 82000
        • Chg Montauban
      • Montpellier, France, 34000
        • University hospital Montpellier
      • Nice, France, 06000
        • University hospital of Nice
      • Tarbes, France, 65000
        • Regional Hospital
      • Toulouse, France, 31300
        • University Hospital toulouse
  • Monaco
      • Monaco, Monaco, 98000
        • Princesse Grace Hospital

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects of both sex, aged of 70 years or over,
  • subjects with at least one of the following frailty criteria: a subjective memory complaint, expressed to their attending physician, an inability to perform one of instrumental activities of daily living, a slow walking with a speed ≤ 0.77 m/s, i.e 5 seconds to walk 4 meters.
  • subjects with an MMSE score of greater than or equal to 24,
  • subjects capable of understanding the protocol, complying with its requirements and attending the study visits,
  • subjects with sufficient availability to take part in the multi-domain intervention programme,
  • subjects who, in the opinion of the investigator, are liable to comply with the treatment during the study;
  • subjects capable of giving their written informed consent
  • Covered by a health insurance system

Exclusion Criteria:

  • Criteria related to diseases:

    • known presence of dementia or Alzheimer's disease (DSM IV criteria),
    • deterioration in global cognitive function (MMSE < 24),
    • dependency for basic activities of daily living (ADL<6),
    • presence of serious diseases, which could be life-threatening in the short term,
    • history or presence of any disease that could compromise the subject's participation in the multi-domain intervention sessions,

  • Criteria related to treatments:

    o taking of supplements containing omega-3 (apart from food) within the past 6 months and/or taking omega-3 at inclusion.

  • Criteria related to subjects:

    • visual or hearing impairments incompatible with performance and/or interpretation of the neuropsychological tests,
    • history or presence of any previous pathologies that could, in the opinion of the investigator, interfere with the results of the study or expose the subject to an additional risk,
    • subjects deprived of their freedom by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution,
    • participation in another clinical study in the previous month or participation scheduled during the study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Omega-3 group without any intervention
Dietary supplement: omega-3
V0137 CA containing 400 mg docosahexaenoic acid (DHA) - 2 soft capsules once a day, i.e. 800 mg DHA per day for 36 months
Other Names:
  • Omega-3 fatty acids
Experimental: 2
Omega-3 combined group (Omega-3 + multi-domain intervention)
Dietary supplement: omega-3
V0137 CA containing 400 mg docosahexaenoic acid (DHA) - 2 soft capsules once a day, i.e. 800 mg DHA per day for 36 months
Other Names:
  • Omega-3 fatty acids
Behavioral: multi-domain intervention
multi-domain intervention = Nutrition, physical exercise, cognitive training and social activities, and preventive consultations
Experimental: 3
Placebo combined group (Placebo + multi-domain intervention)
Behavioral: multi-domain intervention
multi-domain intervention = Nutrition, physical exercise, cognitive training and social activities, and preventive consultations
Drug: Placebo
OMEGA-3 placebo
Placebo Comparator: 4
Placebo group without any intervention
Drug: Placebo
OMEGA-3 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score
Time Frame: Baseline, 6, 12, 24, 36 months
Baseline, 6, 12, 24, 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in other cognitive functions. Changes in functional capacities. To study the long-term safety and tolerability of V0137 CA treatment. To study compliance and adhesion to the "multi-domain" intervention program.
Time Frame: Baseline, 6, 12, 24, 36 months
Baseline, 6, 12, 24, 36 months

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-PhD, Toulouse University Hospital Centre

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

May 1, 2008

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07 116 03

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.

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