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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT00672685

Collaborator

(none)

1,680

Enrollment

Locations

Arms

Duration (Months)

129.2

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Frail Elderly Subjects	Dietary Supplement: omega-3 Behavioral: multi-domain intervention Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1680 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [Baseline, 6, 12, 24, 36 months]

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. [Baseline, 6, 12, 24, 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	University Hospital Bordeaux	Bordeaux	France	33000
2	Regional Hospital	Castres	France	81108
3	University Hospital of Dijon	Dijon	France	21033
4	Regional Hospital	Foix	France	09017
5	Regional Hospital	Lavaur	France	81500
6	University Hospital Limoges	Limoges	France	87000
7	UH of LYON SUD	Lyon	France	69495
8	Chg Montauban	Montauban	France	82000
9	University Hospital Montpellier	Montpellier	France	34000
10	University Hospital of Nice	Nice	France	06000
11	Regional Hospital	Tarbes	France	65000
12	University Hospital Toulouse	Toulouse	France	31300
13	Princesse Grace Hospital	Monaco	Monaco	98000