Back to resultsOmega-3 Fatty Acids and/or Multi-domain Intervention in the Prevention of Age-related Cognitive Decline (MAPT)
Primary Purpose
Frail Elderly Subjects
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
omega-3
multi-domain intervention
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Frail Elderly Subjects focused on measuring Cognitive decline, omega-3 fatty acids, nutrition, physical exercise, cognitive training, social activities, frailty
Eligibility 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.
Sites / Locations
- University Hospital Bordeaux
- Regional Hospital
- University Hospital of Dijon
- Regional Hospital
- Regional Hospital
- University Hospital Limoges
- UH of LYON SUD
- Chg Montauban
- University Hospital Montpellier
- University Hospital of Nice
- Regional Hospital
- University Hospital Toulouse
- Princesse Grace Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Omega-3 group without any intervention
Omega-3 combined group (Omega-3 + multi-domain intervention)
Placebo combined group (Placebo + multi-domain intervention)
Placebo group without any intervention
Outcomes
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
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.
Full Information
NCT ID
NCT00672685
First Posted
May 2, 2008
Last Updated
April 16, 2015
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT00672685
Brief Title
Omega-3 Fatty Acids and/or Multi-domain Intervention in the Prevention of Age-related Cognitive Decline
Acronym
MAPT
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 Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. 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)
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Subjects
Keywords
Cognitive decline, omega-3 fatty acids, nutrition, physical exercise, cognitive training, social activities, frailty
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1680 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Omega-3 group without any intervention
Arm Title
2
Arm Type
Experimental
Arm Description
Omega-3 combined group (Omega-3 + multi-domain intervention)
Arm Title
3
Arm Type
Experimental
Arm Description
Placebo combined group (Placebo + multi-domain intervention)
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo group without any intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3
Other Intervention Name(s)
Omega-3 fatty acids
Intervention Description
V0137 CA containing 400 mg docosahexaenoic acid (DHA) - 2 soft capsules once a day, i.e. 800 mg DHA per day for 36 months
Intervention Type
Behavioral
Intervention Name(s)
multi-domain intervention
Intervention Description
multi-domain intervention = Nutrition, physical exercise, cognitive training and social activities, and preventive consultations
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
OMEGA-3 placebo
Primary Outcome Measure Information:
Title
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
Time Frame
Baseline, 6, 12, 24, 36 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Vellas, MD-PhD
Organizational Affiliation
Toulouse University Hospital Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Regional Hospital
City
Castres
ZIP/Postal Code
81108
Country
France
Facility Name
University Hospital of Dijon
City
Dijon
ZIP/Postal Code
21033
Country
France
Facility Name
Regional Hospital
City
Foix
ZIP/Postal Code
09017
Country
France
Facility Name
Regional Hospital
City
Lavaur
ZIP/Postal Code
81500
Country
France
Facility Name
University Hospital Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
UH of LYON SUD
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
Chg Montauban
City
Montauban
ZIP/Postal Code
82000
Country
France
Facility Name
University Hospital Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
University Hospital of Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Regional Hospital
City
Tarbes
ZIP/Postal Code
65000
Country
France
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Princesse Grace Hospital
City
Monaco
ZIP/Postal Code
98000
Country
Monaco
12. IPD Sharing Statement
Citations:
PubMed Identifier
35606646
Citation
Pages A, Costa N, Mounie M, Cestac P, De Souto Barreto P, Rolland Y, Vellas B, Molinier L, Juillard-Condat B; MAPT/DSA Group. Healthcare Costs Associated with Potentially Inappropriate Medication Prescribing Detected by Computer Algorithm Among Older Patients. Drugs Aging. 2022 May;39(5):367-375. doi: 10.1007/s40266-022-00938-x. Epub 2022 May 24.
Results Reference
derived
PubMed Identifier
35489133
Citation
Rouch L, Rolland Y, Hanon O, Vidal JS, Cestac P, Sallerin B, Andrieu S, Vellas B, Barreto PS; MAPT/DSA Group. Blood pressure, antihypertensive drugs, and incident frailty: The Multidomain Alzheimer Preventive Trial (MAPT). Maturitas. 2022 Aug;162:8-14. doi: 10.1016/j.maturitas.2022.03.001. Epub 2022 Mar 15.
Results Reference
derived
PubMed Identifier
35193041
Citation
Pages A, Costa N, Gonzalez-Bautista E, Mounie M, Juillard-Condat B, Molinier L, Cestac P, Rolland Y, Vellas B, De Souto Barreto P; MAPT/DSA Group. Screening for deficits on intrinsic capacity domains and associated healthcare costs. Arch Gerontol Geriatr. 2022 May-Jun;100:104654. doi: 10.1016/j.archger.2022.104654. Epub 2022 Feb 7.
Results Reference
derived
PubMed Identifier
35037052
Citation
Raffin J, Angioni D, Giudici KV, Valet P, Aggarwal G, Nguyen AD, Morley JE, Guyonnet S, Rolland Y, Vellas B, de Souto Barreto P; MAPT/DSA Group. Physical Activity, Body Mass Index, and Blood Progranulin in Older Adults: Cross-Sectional Associations in the MAPT Study. J Gerontol A Biol Sci Med Sci. 2022 Jun 1;77(6):1141-1149. doi: 10.1093/gerona/glac018.
Results Reference
derived
PubMed Identifier
35034116
Citation
Giudici KV, Guyonnet S, Morley JE, Nguyen AD, Aggarwal G, Parini A, Li Y, Bateman RJ, Vellas B, de Souto Barreto P; MAPT/DSA Group. Interactions Between Weight Loss and Plasma Neurodegenerative Markers for Determining Cognitive Decline Among Community-Dwelling Older Adults. J Gerontol A Biol Sci Med Sci. 2022 Jun 1;77(6):1159-1168. doi: 10.1093/gerona/glac015.
Results Reference
derived
PubMed Identifier
34859035
Citation
Lu WH, Giudici KV, Rolland Y, Guyonnet S, Mangin JF, Vellas B, de Souto Barreto P. Associations Between Nutritional Deficits and Physical Performance in Community-Dwelling Older Adults. Front Nutr. 2021 Nov 11;8:771470. doi: 10.3389/fnut.2021.771470. eCollection 2021.
Results Reference
derived
PubMed Identifier
34674803
Citation
Raffin J, Rolland Y, He L, Perus L, Mangin JF, Gabelle A, Virecoulon Giudici K, Vellas B, de Souto Barreto P; MAPT/DSA Group. Cross-sectional and longitudinal interaction effects of physical activity and APOE-epsilon4 on white matter integrity in older adults: The MAPT study. Maturitas. 2021 Oct;152:10-19. doi: 10.1016/j.maturitas.2021.06.010. Epub 2021 Jun 30.
Results Reference
derived
PubMed Identifier
34585216
Citation
Costa N, Mounie M, Pages A, Derumeaux H, Rapp T, Guyonnet S, Coley N, Cantet C, Carrie I, Andrieu S, Molinier L. The Cost-Effectiveness of Three Prevention Strategies in Alzheimer's Disease: Results from the Multidomain Alzheimer Preventive Trial (MAPT). J Prev Alzheimers Dis. 2021;8(4):425-435. doi: 10.14283/jpad.2021.47.
Results Reference
derived
PubMed Identifier
34560903
Citation
Coley N, Coniasse-Brioude D, Igier V, Fournier T, Poulain JP, Andrieu S; ACCEPT study group. Disparities in the participation and adherence of older adults in lifestyle-based multidomain dementia prevention and the motivational role of perceived disease risk and intervention benefits: an observational ancillary study to a randomised controlled trial. Alzheimers Res Ther. 2021 Sep 24;13(1):157. doi: 10.1186/s13195-021-00904-6.
Results Reference
derived
PubMed Identifier
34352166
Citation
Conejero I, Dubois J, Gutierrez LA, Delrieu J, Arbus C, Garcia M, Lopez-Castroman J, Courtet P, Gabelle A. Amyloid Burden and Depressive Symptom Trajectories in Older Adults at Risk of Developing Cognitive Decline. J Clin Psychiatry. 2021 Aug 3;82(5):20m13410. doi: 10.4088/JCP.20m13410.
Results Reference
derived
PubMed Identifier
34274071
Citation
Gonzalez-Bautista E, de Souto Barreto P, Andrieu S, Rolland Y, Vellas B; MAPT/DSA group (members are listed under 'Contributors'). Screening for intrinsic capacity impairments as markers of increased risk of frailty and disability in the context of integrated care for older people: Secondary analysis of MAPT. Maturitas. 2021 Aug;150:1-6. doi: 10.1016/j.maturitas.2021.05.011. Epub 2021 Jun 4.
Results Reference
derived
PubMed Identifier
33032662
Citation
He L, de Souto Barreto P, Aggarwal G, Nguyen AD, Morley JE, Li Y, Bateman RJ, Vellas B; MAPT/DSA Group. Plasma Abeta and neurofilament light chain are associated with cognitive and physical function decline in non-dementia older adults. Alzheimers Res Ther. 2020 Oct 8;12(1):128. doi: 10.1186/s13195-020-00697-0.
Results Reference
derived
PubMed Identifier
31641729
Citation
Gallini A, Yrondi A, Cantet C, Poncet M, Vellas B, Schmitt L, Andrieu S. Red Blood Cell Omega-3 Fatty Acid Composition and Psychotropic Drug Use in Older Adults: Results from the MAPT Study. J Nutr Health Aging. 2019;23(9):805-812. doi: 10.1007/s12603-019-1252-4.
Results Reference
derived
PubMed Identifier
31628118
Citation
Guerville F, de Souto Barreto P, Taton B, Bourdel-Marchasson I, Rolland Y, Vellas B; Multidomain Alzheimer Preventive Trial (MAPT)/Data Sharing Alzheimer (DSA) Group. Estimated Glomerular Filtration Rate Decline and Incident Frailty in Older Adults. Clin J Am Soc Nephrol. 2019 Nov 7;14(11):1597-1604. doi: 10.2215/CJN.03750319. Epub 2019 Oct 18.
Results Reference
derived
PubMed Identifier
29033827
Citation
Gabelle A, Gutierrez LA, Jaussent I, Navucet S, Grasselli C, Bennys K, Marelli C, David R, Andrieu S, Berr C, Vellas B, Dauvilliers Y. Excessive Sleepiness and Longer Nighttime in Bed Increase the Risk of Cognitive Decline in Frail Elderly Subjects: The MAPT-Sleep Study. Front Aging Neurosci. 2017 Sep 28;9:312. doi: 10.3389/fnagi.2017.00312. eCollection 2017.
Results Reference
derived
PubMed Identifier
28359749
Citation
Andrieu S, Guyonnet S, Coley N, Cantet C, Bonnefoy M, Bordes S, Bories L, Cufi MN, Dantoine T, Dartigues JF, Desclaux F, Gabelle A, Gasnier Y, Pesce A, Sudres K, Touchon J, Robert P, Rouaud O, Legrand P, Payoux P, Caubere JP, Weiner M, Carrie I, Ousset PJ, Vellas B; MAPT Study Group. Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol. 2017 May;16(5):377-389. doi: 10.1016/S1474-4422(17)30040-6. Epub 2017 Mar 27.
Results Reference
derived
PubMed Identifier
19328438
Citation
Gillette-Guyonnet S, Andrieu S, Dantoine T, Dartigues JF, Touchon J, Vellas B; MAPT Study Group. Commentary on "A roadmap for the prevention of dementia II. Leon Thal Symposium 2008." The Multidomain Alzheimer Preventive Trial (MAPT): a new approach to the prevention of Alzheimer's disease. Alzheimers Dement. 2009 Mar;5(2):114-21. doi: 10.1016/j.jalz.2009.01.008.
Results Reference
derived
Learn more about this trial
Omega-3 Fatty Acids and/or Multi-domain Intervention in the Prevention of Age-related Cognitive Decline
We'll reach out to this number within 24 hrs