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Frail Elderly SubjectsMAPTNCT00672685

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

A study testing omega-3 and multi-domain intervention in people with Frail Elderly Subjects, run by University Hospital, Toulouse at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Frail Elderly Subjects
What is being tested?
omega-3 and multi-domain intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,680 participants
Where
13 sitesin 2 countries
Study dates
May 2008to Apr 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 13Show fewer
  • 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.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

France12 sites

  • University Hospital Bordeaux

    Bordeaux, 33000

  • Regional Hospital

    Castres, 81108

  • University Hospital of Dijon

    Dijon, 21033

  • Regional Hospital

    Foix, 09017

  • Regional Hospital

    Lavaur, 81500

  • University Hospital Limoges

    Limoges, 87000

  • UH of LYON SUD

    Lyon, 69495

  • Chg Montauban

    Montauban, 82000

  • University Hospital Montpellier

    Montpellier, 34000

  • University Hospital of Nice

    Nice, 06000

  • Regional Hospital

    Tarbes, 65000

  • University Hospital Toulouse

    Toulouse, 31300

Other trials in France

Monaco1 site

  • Princesse Grace Hospital

    Monaco, 98000

Other trials in Monaco

About this study

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

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.

Read more

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)
Read the 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).
Being tested
omega-3, multi-domain intervention, Placebo
Keywords
Cognitive decline, omega-3 fatty acids, nutrition, physical exercise, cognitive training, social activities, frailty
Medical subject headings
Cognitive Dysfunction, Motor Activity, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • omega-3Dietary supplement

    Also called Omega-3 fatty acids

    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 interventionBehavioural

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

  • PlaceboDrug

    OMEGA-3 placebo

Study groups in NCT00672685
Study groupRoleWhat they receive
1ExperimentalOmega-3 group without any intervention
Receives: Dietary Supplement: omega-3
2ExperimentalOmega-3 combined group (Omega-3 + multi-domain intervention)
Receives: Dietary Supplement: omega-3; Behavioral: multi-domain intervention
3ExperimentalPlacebo combined group (Placebo + multi-domain intervention)
Receives: Behavioral: multi-domain intervention; Drug: Placebo
4Placebo comparatorPlacebo group without any intervention
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, 6, 12, 24, 36 months

Secondary outcomes (1)

  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.

    Measured: Baseline, 6, 12, 24, 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,680 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00672685
Sponsor's protocol ID
07 116 03
Acronym
MAPT
Status last verified
Apr 2015
First submitted
2 May 2008
Last updated
17 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39821948

  • 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.

    PubMed 39754932

  • 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.

    PubMed 37233882

  • 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.

    PubMed 36508390

  • 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.

    PubMed 35606646

  • 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.

    PubMed 35489133

  • 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.

    PubMed 35226732

  • 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.

    PubMed 35193041

  • 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.

    PubMed 35037052

  • 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.

    PubMed 35037034

  • 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.

    PubMed 35034116

  • 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.

    PubMed 34859035

  • 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.

    PubMed 34674803

  • 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.

    PubMed 34585216

  • 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.

    PubMed 34560903

Questions about this trial

What is this clinical trial studying?

A study testing omega-3 and multi-domain intervention in people with Frail Elderly Subjects, run by University Hospital, Toulouse at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00672685, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.

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