CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,680 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00672685
NCT00672685N/ACompleted

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

University Hospital, Toulouse·interventional·Posted May 6, 2008·Updated Apr 17, 2015

In Brief

A clinical study evaluating omega-3, multi-domain intervention, and 1 other intervention for Frail Elderly Subjects. Completed, enrolled 1,680 participants across 13 sites in 2 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Monaco
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 6, 2008
Enrollment StartMay 1, 2008
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 18.2 years ago

Interventions

omega-3dietary

V0137 CA containing 400 mg docosahexaenoic acid (DHA) - 2 soft capsules once a day, i.e. 800 mg DHA per day for 36 months

multi-domain interventionbehavioral

multi-domain intervention = Nutrition, physical exercise, cognitive training and social activities, and preventive consultations

Placebodrug

OMEGA-3 placebo