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

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).

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.