Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training

NCT02977819 | Completed DMC

• 2 other identifiers: C16-382016-A01767-44
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

As the number of older people in Europe grows, increasing healthy life years is a priority. As people live longer, ensuring good mental as well as physical health into later years is becoming ever more important. Cognitive decline, dementia (e.g. Alzheimer's Disease, AD), sleep disturbances and depression, all related to psychological distress and anxiety, are significant drivers of reduced quality of life in older adults. This project builds on evidence that meditation practice have the potential to downregulate these adverse factors and positively impact mental and neurological conditions including AD.

Conditions

Cognitive Aging

Outcome Measures

Primary Outcomes (4)

• Estimate the effect of an 18-month meditation intervention in non-meditating senior participants on the volume of the anterior cingulate cortex compared to a passive control intervention

  change in anterior cingulate cortex volume (T1-weighted MRI)

  Visit 1 inclusion - Visit 3 Month 18

• Estimate the effect of an 18-month meditation intervention in non-meditating senior participants on the perfusion of the anterior cingulate cortex compared to a passive control intervention

  change in anterior cingulate cortex perfusion (early PET-Amyvid® scan)

  Visit 1 inclusion - Visit 3 Month 18

• Estimate the effect of an 18-month meditation intervention in non-meditating seniors on the volume of the insula compared to an 18 months intervention of learning a foreign language

  change in insula volume (T1-weighted MRI)

  Visit 1 inclusion - Visit 3 Month 18

• Estimate the effect of an 18-month meditation intervention in non-meditating seniors on the perfusion of the insula compared to an 18 months intervention of learning a foreign language

  change in insula perfusion (early PET-Amyvid® scan)

  Visit 1 inclusion - Visit 3 Month 18

Secondary Outcomes (35)

• Comparison between meditation intervention and language learning intervention on the global metacognitive composite score

  up to 35 months post intervention

• Composite score per cognitive area assessed by the neuropsychological tests and the questionnaires

  up to 35 months post intervention

• Medical neuroimaging using MRI: grey and white matter volume in all brain voxels

  up to 35 months post intervention

• Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes

  up to 35 months post intervention

• Medical neuroimaging using MRI: brain perfusion in all brain voxels

  up to 35 months post intervention

Study Arms (3)

Meditation program

EXPERIMENTAL

Meditation courses and at-home practice

Other: Meditation practice

English learning courses

ACTIVE COMPARATOR

English learning courses and at-home practice

Other: Learning English as a foreign language

No intervention

NO INTERVENTION

Follow-up without Meditation courses or English Learning courses

Interventions

Meditation practice OTHER

18 months

Meditation program

Learning English as a foreign language OTHER

18 months

English learning courses

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• For all participants
• Age ≥ 65 years ;
• To be autonomous
• Live in their home;
• Educational level ≥ 7 years (from the Preparatory Course (First grade) included);
• To be registered to the social security system ;
• To be motivated to effectively participate in the project and to sign the consent form in agreement with the local ethic committee ;
• Neuropsychological performances within the normal range (according to age, sex, and educational level), as assessed by the diagnostic battery.
• For participants without previous meditation practice
• French mother tongue;
• Available for the trial duration (24 months);
• Retired since 1 year or more;
• No preference regarding the intervention group ;
• Not having regularly or intensively practiced meditation or comparable practices (yoga, Qi Gong, Alexander technique) as follows :
• more than one day per week for more than six months consecutively over the last 10 years,

You may not qualify if:

• Contraindication to MRI or PET Amyvid® ;
• For security reasons realted with the use of Amyvid®, a blood sampling allowing to measure hepatic and renal functions will be performed at the V1 visit before the PET-Amyvid® scan. In case anomalies are detected of grade 3 or higher severity, the PET-Amyvid® scan will not be performed.
• Hypersensitivity to Amyvid®
• History or presence of a major neurological or psychiatric disorder (including an addiction to alcohol or drugs);
• History of cerebral disease (vascular, degenerative, physical malformation, tumor, or head trauma with loss of consciousness for more than an hour);
• Presence of a chronic disease or acute unstable illness (respiratory, cardiovascular, digestive, renal, metabolic, hematologic, endocrine or infectious);
• Current or recent medication that may interfere with cognitive action or radiological measures (psychotropic drugs, antihistamines, anti-Parkinsonian drugs, benzodiazepines, non-steroidal anti-inflammatory agents, antiepileptics, central analgesic and muscle relaxants);
• Under legal guardianship or incapacitation;
• Physical of behavioural inhabilities to perform the follow-up visits as planned in the study protocol.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

GIP Cyceron

Caen, Calvados, 14000, France

Location

Related Publications (17)

• Chetelat G, Lutz A, Klimecki O, Frison E, Asselineau J, Schlosser M, Arenaza-Urquijo EM, Mezenge F, Kuhn E, Moulinet I, Touron E, Dautricourt S, Andre C, Palix C, Ourry V, Felisatti F, Gonneaud J, Landeau B, Rauchs G, Chocat A, Quillard A, Devouge EF, Vuilleumier P, de La Sayette V, Vivien D, Collette F, Poisnel G, Marchant NL; Medit-Ageing Research Group. Effect of an 18-Month Meditation Training on Regional Brain Volume and Perfusion in Older Adults: The Age-Well Randomized Clinical Trial. JAMA Neurol. 2022 Nov 1;79(11):1165-1174. doi: 10.1001/jamaneurol.2022.3185.

  PMID: 36215061 BACKGROUND

• Schlosser M, Klimecki OM, Collette F, Gonneaud J, Kliegel M, Marchant NL, Chetelat G, Lutz A; Medit-Ageing Research Group. An 18-month meditation training selectively improves psychological well-being in older adults: A secondary analysis of a randomised controlled trial. PLoS One. 2023 Dec 1;18(12):e0294753. doi: 10.1371/journal.pone.0294753. eCollection 2023.

  PMID: 38039341 BACKGROUND

• Poisnel G, Arenaza-Urquijo E, Collette F, Klimecki OM, Marchant NL, Wirth M, de La Sayette V, Rauchs G, Salmon E, Vuilleumier P, Frison E, Maillard A, Vivien D, Lutz A, Chetelat G; Medit-Ageing Research Group. The Age-Well randomized controlled trial of the Medit-Ageing European project: Effect of meditation or foreign language training on brain and mental health in older adults. Alzheimers Dement (N Y). 2018 Dec 14;4:714-723. doi: 10.1016/j.trci.2018.10.011. eCollection 2018.

  PMID: 30581977 BACKGROUND

• Haudry S, Dautricourt S, Gonneaud J, Landeau B, Calhoun VD, de Flores R, Poisnel G, Bougacha S, Kuhn E, Touron E, Chauveau L, Felisatti F, Palix C, Vivien D, de la Sayette V, Lutz A, Chetelat G. Effects of an 18-month meditation training on dynamic functional connectivity states in older adults: Secondary analyses from the Age-Well randomized controlled trial. Imaging Neurosci (Camb). 2025 Jun 10;3:IMAG.a.33. doi: 10.1162/IMAG.a.33. eCollection 2025.

  PMID: 40800757 DERIVED

• Champetier P, Hamel A, Andre C, Ourry V, Lacroix T, Rehel S, Chauveau L, Haudry S, Bertran F, de la Sayette V, Vivien D, Chetelat G, Lutz A, Rauchs G; Medit-Ageing Research Group. EEG Brain Rhythms During Resting-State Wakefulness and Sleep in Elderly Expert Meditators. J Sleep Res. 2025 Jul 29:e70161. doi: 10.1111/jsr.70161. Online ahead of print.

  PMID: 40731281 DERIVED

• Chauveau L, Gonneaud J, Poisnel G, Landeau B, Garnier-Crussard A, Pitel AL, Roquet D, Touron E, Haudry S, Mezenge F, Chocat A, Vivien D, de La Sayette V, Chetelat G, de Flores R; Medit-Ageing Research Group. Cardiovascular risk factors are associated with lower posterior-medial network functional connectivity in older adults. Alzheimers Res Ther. 2025 Jul 15;17(1):159. doi: 10.1186/s13195-025-01808-5.

  PMID: 40665410 DERIVED

• Requier F, Mohammadi H, Demnitz-King H, Schlosser M, Poisnel G, Salmon E, Chetelat G, Marchant NL, Lutz A, Collette F; Medit-Ageing Research Group. Examining cognitive differences in expert meditators and non-meditators older adults. Sci Rep. 2025 May 15;15(1):16898. doi: 10.1038/s41598-025-00226-9.

  PMID: 40374672 DERIVED

• Touron E, de Flores R, Coulbault L, Palix C, Chocat A, Kuhn E, Landeau B, Mezenge F, Roquet D, Chauveau L, Haudry S, Vivien D, de La Sayette V, Marchant NL, Chetelat G, Poisnel G; Medit-Ageing Research Group. Depressive symptoms in older adults are associated with changes in stress-related markers, functional connectivity and brain volume. Alzheimers Res Ther. 2025 Jan 6;17(1):9. doi: 10.1186/s13195-024-01643-0.

  PMID: 39762947 DERIVED

• Garnier-Crussard A, Gonneaud J, Felisatti F, Palix C, Ferrand Devouge E, Chocat A, Rauchs G, de la Sayette V, Vivien D, Demnitz-King H, Lutz A, Chetelat G, Poisnel G; Medit-Ageing Research Group. Effect of an 18-month meditation training on cardiovascular risk in older adults: a secondary analysis of the Age-Well randomized controlled trial. BMC Geriatr. 2024 Nov 16;24(1):954. doi: 10.1186/s12877-024-05550-9.

  PMID: 39550530 DERIVED

• Champetier P, Andre C, Rehel S, Ourry V, Landeau B, Mezenge F, Roquet D, Vivien D, de La Sayette V, Chetelat G, Rauchs G; Medit-Ageing Research Group. Multimodal neuroimaging correlates of spectral power in NREM sleep delta sub-bands in cognitively unimpaired older adults. Sleep. 2024 Apr 12;47(4):zsae012. doi: 10.1093/sleep/zsae012.

  PMID: 38227830 DERIVED

• Ourry V, Rehel S, Andre C, Mary A, Paly L, Delarue M, Requier F, Hendy A, Collette F, Marchant NL, Felisatti F, Palix C, Vivien D, de la Sayette V, Chetelat G, Gonneaud J, Rauchs G; Medit-Ageing Research Group. Effect of cognitive reserve on the association between slow wave sleep and cognition in community-dwelling older adults. Aging (Albany NY). 2023 Sep 28;15(18):9275-9292. doi: 10.18632/aging.204943. Epub 2023 Sep 28.

  PMID: 37770186 DERIVED

• Demnitz-King H, Requier F, Whitfield T, Schlosser M, Gonneaud J, Ware C, Barnhofer T, Coll-Padros N, Dautricourt S, Delarue M, Klimecki OM, Paly L, Salmon E, Schild AK, Wirth M, Frison E, Lutz A, Chetelat G, Collette F, Marchant NL; Medit-Ageing Research Group. Effects of Meditation Training and Non-Native Language Training on Cognition in Older Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2317848. doi: 10.1001/jamanetworkopen.2023.17848.

  PMID: 37450303 DERIVED

• Andre C, Kuhn E, Rehel S, Ourry V, Demeilliez-Servouin S, Palix C, Felisatti F, Champetier P, Dautricourt S, Yushkevich P, Vivien D, de La Sayette V, Chetelat G, de Flores R, Rauchs G; Medit-Ageing Research Group. Association of Sleep-Disordered Breathing and Medial Temporal Lobe Atrophy in Cognitively Unimpaired Amyloid-Positive Older Adults. Neurology. 2023 Jul 25;101(4):e370-e385. doi: 10.1212/WNL.0000000000207421. Epub 2023 May 31.

  PMID: 37258299 DERIVED

• Champetier P, Andre C, Weber FD, Rehel S, Ourry V, Laniepce A, Lutz A, Bertran F, Cabe N, Pitel AL, Poisnel G, de la Sayette V, Vivien D, Chetelat G, Rauchs G. Age-related changes in fast spindle clustering during non-rapid eye movement sleep and their relevance for memory consolidation. Sleep. 2023 May 10;46(5):zsac282. doi: 10.1093/sleep/zsac282.

  PMID: 36433753 DERIVED

• Demnitz-King H, Gonneaud J, Klimecki OM, Chocat A, Collette F, Dautricourt S, Jessen F, Krolak-Salmon P, Lutz A, Morse RM, Molinuevo JL, Poisnel G, Touron E, Wirth M, Walker Z, Chetelat G, Marchant NL; Medit-Ageing Research Group. Association of Self-reflection With Cognition and Brain Health in Cognitively Unimpaired Older Adults. Neurology. 2022 Sep 27;99(13):e1422-e1431. doi: 10.1212/WNL.0000000000200951. Epub 2022 Jul 19.

  PMID: 35853750 DERIVED

• Felisatti F, Gonneaud J, Palix C, Garnier-Crussard A, Mezenge F, Landeau B, Chocat A, Quillard A, Ferrand-Devouge E, de La Sayette V, Vivien D, Chetelat G, Poisnel G; Medit-Ageing Research Group. Role of Cardiovascular Risk Factors on the Association Between Physical Activity and Brain Integrity Markers in Older Adults. Neurology. 2022 May 17;98(20):e2023-e2035. doi: 10.1212/WNL.0000000000200270. Epub 2022 Apr 13.

  PMID: 35418459 DERIVED

• Andre C, Rehel S, Kuhn E, Landeau B, Moulinet I, Touron E, Ourry V, Le Du G, Mezenge F, Tomadesso C, de Flores R, Bejanin A, Sherif S, Delcroix N, Manrique A, Abbas A, Marchant NL, Lutz A, Klimecki OM, Collette F, Arenaza-Urquijo EM, Poisnel G, Vivien D, Bertran F, de la Sayette V, Chetelat G, Rauchs G; Medit-Ageing Research Group. Association of Sleep-Disordered Breathing With Alzheimer Disease Biomarkers in Community-Dwelling Older Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2020 Jun 1;77(6):716-724. doi: 10.1001/jamaneurol.2020.0311.

  PMID: 32202593 DERIVED

Study Officials

• De La Sayette Vincent

  CHU Caen - France

  PRINCIPAL INVESTIGATOR

• Chételat Gaël

  GIP Cyceron Caen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 30, 2016
• Study Start: November 24, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 9, 2023
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: December 2020
• Access Criteria: * specific information (quantity of Data available on a given date, number of patients included in the Cohort meeting the specific selection criteria for SRP requests, etc.) necessary for the conception of the SRP request; * the price list for the mobilization of Data within the framework of the SRP. * the list of services likely to be performed by the signatories of the Consortium Agreement for the purposes of the SRP request, as well as the associated price list; * a quote for services not included in the price list.

Locations

FR (1)