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

NCT00672685 | Completed

• 1 other identifier: 07 116 03
• Study Type: interventional
• Target: 1,680
• Locations: 2 countries
• Sites: 13

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)

Conditions

Frail Elderly Subjects

Keywords

Cognitive decline; omega-3 fatty acids; nutrition; physical exercise; cognitive training; social activities; frailty

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 6, 12, 24, 36 months

Secondary Outcomes (1)

• 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.

  Baseline, 6, 12, 24, 36 months

Study Arms (4)

1

EXPERIMENTAL

Omega-3 group without any intervention

Dietary Supplement: omega-3

2

EXPERIMENTAL

Omega-3 combined group (Omega-3 + multi-domain intervention)

Dietary Supplement: omega-3; Behavioral: multi-domain intervention

3

EXPERIMENTAL

Placebo combined group (Placebo + multi-domain intervention)

Behavioral: multi-domain intervention; Drug: Placebo

4

PLACEBO COMPARATOR

Placebo group without any intervention

Drug: Placebo

Interventions

omega-3 DIETARY_SUPPLEMENT

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

Also known as: Omega-3 fatty acids

1; 2

multi-domain intervention BEHAVIORAL

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

2; 3

Placebo DRUG

OMEGA-3 placebo

3; 4

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (13)

University Hospital Bordeaux

Bordeaux, 33000, France

Location

Regional Hospital

Castres, 81108, France

Location

University Hospital of Dijon

Dijon, 21033, France

Location

Regional Hospital

Foix, 09017, France

Location

Regional Hospital

Lavaur, 81500, France

Location

University Hospital Limoges

Limoges, 87000, France

Location

UH of LYON SUD

Lyon, 69495, France

Location

Chg Montauban

Montauban, 82000, France

Location

University Hospital Montpellier

Montpellier, 34000, France

Location

University Hospital of Nice

Nice, 06000, France

Location

Regional Hospital

Tarbes, 65000, France

Location

University Hospital Toulouse

Toulouse, 31300, France

Location

Princesse Grace Hospital

Monaco, 98000, Monaco

Location

Related Publications (23)

• Coley N, Hoevenaar-Blom MP, Shourick J, van Charante EPM, van Dalen JW, van Gool WA, Richard E, Andrieu S; preDIVA study group and the MAPT/IHU HealthAge Open Science group. Searching for responders to multidomain dementia prevention in late life: A pooled analysis of individual participant data from the MAPT and preDIVA trials. Alzheimers Dement. 2025 Feb;21(2):e14472. doi: 10.1002/alz.14472. Epub 2025 Jan 17.

  PMID: 39821948 DERIVED

• de Assuncao Cortez Correa LC, Raffin J, Vellas B, Guerra RO, de Souto Barreto P. Sex-specific associations of neurodegeneration and inflammatory biomarkers with intrinsic capacity in older adults: Findings from the 4-year longitudinal Multidomain Alzheimer's Prevention Trial (MAPT). Maturitas. 2025 Feb;193:108191. doi: 10.1016/j.maturitas.2024.108191. Epub 2025 Jan 3.

  PMID: 39754932 DERIVED

• Aggarwal G, Morley JE, Vellas B, Nguyen AD, Butler AA; MAPT/DSA Group. Low circulating adropin concentrations predict increased risk of cognitive decline in community-dwelling older adults. Geroscience. 2024 Feb;46(1):897-911. doi: 10.1007/s11357-023-00824-3. Epub 2023 May 26.

  PMID: 37233882 DERIVED

• Giudici KV, de Souto Barreto P, Guyonnet S, Morley JE, Nguyen AD, Aggarwal G, Parini A, Li Y, Bateman RJ, Vellas B; MAPT/DSA Group. TNFR-1 and GDF-15 Are Associated With Plasma Neurofilament Light Chain and Progranulin Among Community-Dwelling Older Adults: A Secondary Analysis of the MAPT Study. J Gerontol A Biol Sci Med Sci. 2023 Mar 30;78(4):569-578. doi: 10.1093/gerona/glac244.

  PMID: 36508390 DERIVED

• 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.

  PMID: 35606646 DERIVED

• 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.

  PMID: 35489133 DERIVED

• Gonzalez-Bautista E, de Souto Barreto P, Salinas-Rodriguez A, Manrique-Espinoza B, Sourdet S, Rolland Y, Rodriguez-Manas L, Andrieu S, Vellas B; MAPT/DSA Group. Development and Validation of a Cutoff for the Chair Stand Test as a Screening for Mobility Impairment in the Context of the Integrated Care for Older People Program. J Gerontol A Biol Sci Med Sci. 2023 Jan 26;78(1):104-110. doi: 10.1093/gerona/glac055.

  PMID: 35226732 DERIVED

• 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.

  PMID: 35193041 DERIVED

• 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.

  PMID: 35037052 DERIVED

• He L, de Souto Barreto P, Sanchez Sanchez JL, Rolland Y, Guyonnet S, Parini A, Lucas A, Vellas B; MAPT/DSA Group. Prospective Associations of Plasma Growth Differentiation Factor 15 With Physical Performance and Cognitive Functions in Older Adults. J Gerontol A Biol Sci Med Sci. 2022 Dec 29;77(12):2420-2428. doi: 10.1093/gerona/glac020.

  PMID: 35037034 DERIVED

• 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.

  PMID: 35034116 DERIVED

• 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.

  PMID: 34859035 DERIVED

• 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.

  PMID: 34674803 DERIVED

• 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.

  PMID: 34585216 DERIVED

• 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.

  PMID: 34560903 DERIVED

• 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.

  PMID: 34352166 DERIVED

• 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.

  PMID: 34274071 DERIVED

• 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.

  PMID: 33032662 DERIVED

• 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.

  PMID: 31641729 DERIVED

• 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.

  PMID: 31628118 DERIVED

• 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.

  PMID: 29033827 DERIVED

• 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.

  PMID: 28359749 DERIVED

• 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.

  PMID: 19328438 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity; Frailty

Interventions

Docosahexaenoic Acids; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Bruno Vellas, MD-PhD

  Toulouse University Hospital Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

FR (12); MO (1)