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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00672685
First received: May 2, 2008
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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,

    • 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)

Condition Intervention
Frail Elderly Subjects
Dietary Supplement: omega-3
Behavioral: multi-domain intervention
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Changes in memory function scores at 36 months determined by Gröber & Buscke test [ Time Frame: Baseline, 6, 12, 24, 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1680
Study Start Date: May 2008
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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

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).
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00672685

Locations
France
University Hospital Bordeaux
Bordeaux, France, 33000
Regional Hospital
Castres, France, 81108
University Hospital of Dijon
Dijon, France, 21033
Regional Hospital
Foix, France, 09017
Regional Hospital
Lavaur, France, 81500
University Hospital Limoges
Limoges, France, 87000
UH of LYON SUD
Lyon, France, 69495
Chg Montauban
Montauban, France, 82000
University Hospital Montpellier
Montpellier, France, 34000
University Hospital of Nice
Nice, France, 06000
Regional Hospital
Tarbes, France, 65000
University Hospital Toulouse
Toulouse, France, 31300
Monaco
Princesse Grace Hospital
Monaco, Monaco, 98000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Bruno Vellas, MD-PhD Toulouse University Hospital Centre
  More Information

No publications provided by University Hospital, Toulouse

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00672685     History of Changes
Other Study ID Numbers: 07 116 03
Study First Received: May 2, 2008
Last Updated: July 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Cognitive decline
omega-3 fatty acids
nutrition
physical exercise
cognitive training
social activities
frailty

ClinicalTrials.gov processed this record on September 30, 2014