Ignite Creation Date:
2024-05-05 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00672685
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2008-05-02
Brief Title:
Omega-3 Fatty Acids andor Multi-domain Intervention in the Prevention of Age-related Cognitive Decline
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAPT
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 Alzheimers 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
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
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 mgday of docosahexaenoic acid V0137CA nutritional supplement
Omega-3 multi-domain intervention group 800 mgday 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
Omega-3 group 800 mgday of docosahexaenoic acid V0137CA nutritional supplement
Omega-3 multi-domain intervention group 800 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None