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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 January 2013
• Main ID: NCT00672685
• Date of registration: 02/05/2008
• Primary sponsor: University Hospital, Toulouse
• Public title: Omega-3 Fatty Acids and/or Multi-domain Intervention in the Prevention of Age-related Cognitive Decline MAPT
• Scientific 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
• Date of first enrolment: May 2008
• Target sample size: 1680
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00672685
• 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

Countries of recruitment

France, Monaco

Contacts

• Name: Bruno Vellas, MD-PhD
• Affiliation: Toulouse University Hospital Centre

Key inclusion & exclusion 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.



Age minimum: 70 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Frail Elderly Subjects

Intervention(s)

Behavioral: multi-domain intervention

Dietary Supplement: omega-3

Drug: Placebo

Primary Outcome(s)

Changes in memory function scores at 36 months determined by Gröber & Buscke test [Time Frame: Baseline, 6, 12, 24, 36 months]

Secondary Outcome(s)

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]

Secondary ID(s)

07 116 03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors