Cognitive AgingAge-WellNCT02977819
Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training
A study testing Meditation practice and Learning English as a foreign language in people with Cognitive Aging, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Aging
- What is being tested?
- Meditation practice and Learning English as a foreign language
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2016to 9 Dec 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
- Inclusion Criteria : 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,
- intensively (internship or retreat > five consecutive days) over the past 10 years,
- more than 25 days of retreats (cumulatively) prior to the last 10 years ;
- Not speaking English fluently. For expert meditators :
- Formal meditation practice > 10 000 hours in the whole life, including at least 6 cumulated months of retreat;
- Daily meditation practice (at least 6 days/week, 45 minutes/day);
- Mindfulness meditation practice (i.e. mindfulness, samatha/vipassana, zazen (zen), shikantaza (zen), focused attention, mahamudra/Dzogchen, and compassion/loving jindness (tonglen, metta/karuna, bodhichitta)
- Exclusion criteria :
- 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;
- Inclusion in another biomedical research protocol at baseline, if including use of a radiolabel for radiological measures;
- Physical of behavioural inhabilities to perform the follow-up visits as planned in the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training and Foreign Language Learning on Behavioral, Biological and Neuroimaging Measures
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.
Read the detailed description
Understanding of the neurocognitive mechanisms of meditation is still limited. Meditation can be conceptualized as "a set of complex emotional and attentional regulation strategies developed for a variety of purposes including the development of emotional well-being and balance". Affective (emotional) and cognitive (attentional) control are therefore the most likely mechanisms by which meditation could impact aging and AD. Specifically, meditation could enhance the controlling role of mid-brain structures and the executive network over structures involved in memory, emotions, and regulation of the immune system. This would lead to better emotional and cognitive control which in turn would be associated with improved mental and physical health.
- Conditions
- Cognitive Aging
- Being tested
- Meditation practice, Learning English as a foreign language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation practiceOther
18 months
Learning English as a foreign languageOther
18 months
| Study group | Role | What they receive |
|---|---|---|
| Meditation program | Experimental | Meditation courses and at-home practice Receives: Other: Meditation practice |
| English learning courses | Active comparator | English learning courses and at-home practice Receives: Other: Learning English as a foreign language |
| No intervention | No intervention | Follow-up without Meditation courses or English Learning courses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Visit 1 inclusion - Visit 3 Month 18
Secondary outcomes (35)
Comparison between meditation intervention and language learning intervention on the global metacognitive composite score
consisting in the mean of the attentional, constructive and deconstructive subscores (main behavioural outcome) Each composite score is computed by averaging its respective standardised scale scores (range (-3) - (4) , Higher score of the meditation composite score mean better outcome)
Measured: up to 35 months post intervention
Composite score per cognitive area assessed by the neuropsychological tests and the questionnaires
composite scores will be computed as z-scores calculated from all the cognitive scores obtained for the corresponding cognitive function that will have a normal distribution and will not have a floor or ceiling effect. Additional exploratory analyses will be conducted on all individual behavioural measures obtained.
Measured: up to 35 months post intervention
Medical neuroimaging using MRI: grey and white matter volume in all brain voxels
grey and white matter volume in all brain voxels
Measured: up to 35 months post intervention
Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes
hippocampal and hippocampal subfield volumes
Measured: up to 35 months post intervention
Medical neuroimaging using MRI: brain perfusion in all brain voxels
brain perfusion in all brain voxels
Measured: up to 35 months post intervention
Medical neuroimaging using MRI: fractional anisotropy and mean diffusivity in all brain voxels
fractional anisotropy and mean diffusivity in all brain voxels
Measured: up to 35 months post intervention
Medical neuroimaging using MRI: number, size, type and location of white matter lesions
number, size, type and location of white matter lesions
Measured: up to 35 months post intervention
Medical neuroimaging using MRI: magnetic susceptibility index in all brain voxels
magnetic susceptibility index in all brain voxels
Measured: up to 35 months post intervention
Medical neuroimaging using MRI: brain functional connectivity measures in all brain voxels at rest in a non-meditative state
brain functional connectivity measures in all brain voxels at rest in a non-meditative state
Measured: up to 35 months post intervention
Beta-amyloid charge (of the radiopharmarceutical Amyvid®) measured in each voxel of the brain and gross mean in gray matter
measured in each voxel of the brain and gross mean in gray matter
Measured: up to 35 months post intervention
Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum)
Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum) by TEP
Measured: up to 35 months post intervention
Medical neuroimaging using fMRI: Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task.
Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task.
Measured: up to 35 months post intervention
Medical neuroimaging using fMRI: Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task.
Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task.
Measured: up to 35 months post intervention
Medical neuroimaging using PET-scan and Amyvid® radiotracer
Brain amyloid load (of the PET-Amyvid® radiotracer) measured in global grey matter mask
Measured: up to 35 months post intervention
Subjectives sleep measures with sleep quality index z-score mean of the scores at questionnaires
Epworth scale, Leeds Sleep evaluation questionnaire, Pittsburg Sleep Quality Scale, St Mary's hospital questionnaire, Berlin Questionnaire, and Insomnia severity index.
Measured: up to 35 months post intervention
Mean duration of sleep
Data collected by actimetrics record
Measured: up to 35 months post intervention
fragmentation indices during activity and resting states
Data collected by actimetrics record
Measured: up to 35 months post intervention
regularity of the rest-activity cycle
Data collected by actimetrics record
Measured: up to 35 months post intervention
Mean z-score of total sleep time
Data collected during polysomnographic sleep record with Somno-Art device
Measured: up to 35 months post intervention
Mean z-score of sleep onset latency
Data collected during polysomnographic sleep record with Somno-Art device
Measured: up to 35 months post intervention
Mean z-score of sleep efficiency
Data collected during polysomnographic sleep record with Somno-Art device
Measured: up to 35 months post intervention
Biological blood tests
tau, phosphotau, Ab 40, 42, APOE4, NFL, BDNF, GWAS, cytokines, CRP, cortisol, serotonine, SDHEA, SHBG, E2, testosterone, glycemie, insuline, BNP, tPA, PAI-1, peroxyredoxine
Measured: up to 35 months post intervention
Telomerase properties by blood tests
Telomerasic activity, telomerase length
Measured: visit 1 baseline -Visit 3 18 months
lymphocytic immunophenotyping
biological blood tests
Measured: visit 1 baseline -Visit 3 18 months
Difference in partner perceptions of participant mindfulness measured by Five-Facet Mindfulness Questionnaire (FFMQ-15, range 15-75, higher scores indicate greater mindfulness)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant.
Measured: up to 35 months post intervention
Difference in partner perceptions of participant compassion towards others measured by Compassionate Love Scale (Range 21-147, higher scores indicate greater compassion)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Measured: up to 35 months post intervention
Difference in partner perceptions of participant depression measured by the Geriatric Depression Scale (range 0-15, higher scores indicate greater depressive symptoms)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Measured: up to 35 months post intervention
Scores to evaluate the impact on volunteers' relatives
scores to hetero questionnaires fulfilled by relatives and qualitative data from interviews with the participants on one hand and with the teachers on the other hand
Measured: up to 35 months post intervention
Difference in partner perceptions of participant anxiety measured by trait subscale of the state-trait anxiety inventory (trait-STAI, range 20-80, higher scores indicate greater anxiety symptoms)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Measured: up to 35 months post intervention
Difference in partner perceptions of participant prosocialness measured by Prosocialness scale (range 16-80, higher scores indicate greater prosocialness)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Measured: up to 35 months post intervention
Difference in partner perceptions of participant's cognitive difficulties in everyday life, measured by Mc Nair CDS (range 0-156, higher score indicates greater cognitive difficulties)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Measured: up to 35 months post intervention
Neural signature of meditative practices using brain medical imaging (neuronal activity in each cerebral voxel (fMRI) at rest and during the emotional task, in a mindfulness meditative state versus not; in compasional meditative state or not)
only for meditation experts
Measured: up to 35 months post intervention
Safety and acceptance
recording adverse events, measurement of anxiety, depression, satisfaction, and well-being using questionnaires
Measured: up to 35 months post intervention
evaluation of the practice of the meditation practice and language learning at long-term (29 months post-intervention)
questionnaire about the practice (meditation or foreign language)
Measured: up to 35 months post intervention (because V4 = 29 months post intervention with a window of 6 months
Behavioral measures (questionnaires) to evaluate the psychological impact of the confinement
composite score per function (anxiety, stress, auto-compassion...)
Measured: up to 35 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start24 Nov 2016
- Primary completion31 Dec 2019
- Study completion9 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Cognitive AgingStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- De La Sayette Vincent, Principal investigator, CHU Caen - FranceChételat Gaël, Study director, GIP Cyceron Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977819
- Sponsor's protocol ID
- C16-38
- Other IDs
- 2016-A01767-44
- Acronym
- Age-Well
- Status last verified
- Feb 2025
- First submitted
- 4 Nov 2016
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data access of AGE-WELL and SCD-WELL studies of the MEDIT-AGEING project for which Institut national de la santé et de la recherche médicale (Inserm) is the sponsor. The Material can be mobilized, under the conditions and modalities defined in the Charter, by any research team belonging to an Academic signatory to the Consortium Agreement concluded for the needs of the Project or by any research team belonging to an Academic outside the Consortium Agreement, French or foreign, for carrying out SRP relating to the scientific theme of mental health and wellbeing in older people. The Material may also be mobilized, by non-academic third parties for the realization of SRP relating to the scientific theme of mental health and wellbeing in older people, under conditions, in particular financial, which will be established by separate agreement between Inserm and by the said third party.
Publications
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.
PubMed 30581977Chetelat 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.
PubMed 36215061Schlosser 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.
PubMed 38039341Montagne B, Boulin M, Hamel A, Champetier P, Rehel S, Mezenge F, Landeau B, Delarue M, Hebert O, Soussi C, Bertran F, Chetelat G, Andre C, Rauchs G; Medit-Ageing Research Group. Night-to-night rapid eye movement sleep variability: A relevant marker of early amyloid-beta deposition. Alzheimers Dement. 2026 Apr;22(4):e71376. doi: 10.1002/alz.71376.
PubMed 41996149Foyard E, Blanchard T, Landeau B, Chauveau L, Naveau M, Poisnel G, Bui E, Chetelat G, de Flores R; Medit-Ageing Research Group. Altered locus coeruleus links to atrophy and hypometabolism in individuals with high Alzheimer's disease biomarkers. Alzheimers Dement. 2026 Mar;22(3):e71212. doi: 10.1002/alz.71212.
PubMed 41772375Lehodey A, Montagne B, Rehel S, Kaliman P, Chocat A, Mezenge F, Landeau B, de la Sayette V, Chetelat G, Rauchs G, Poisnel G; Medit-Ageing Research Group. Telomere dynamics are influenced by sleep, sleep variability and circadian rhythms in older adults with or without alzheimer's risk. Alzheimers Res Ther. 2025 Dec 5;18(1):10. doi: 10.1186/s13195-025-01923-3.
PubMed 41345970Haudry 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.
PubMed 40800757Champetier 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. 2026 Apr;35(2):e70161. doi: 10.1111/jsr.70161. Epub 2025 Jul 29.
PubMed 40731281Chauveau 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.
PubMed 40665410Requier 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.
PubMed 40374672Touron 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.
PubMed 39762947Lehodey A, Kaliman P, Palix C, de Flores R, Touron E, Turpin AL, Fauvel S, Mezenge F, Landeau B, Chocat A, Vrillon A, Paquet C, Vivien D, de La Sayette V, Chetelat G, Poisnel G; Medit-Ageing Research Group. Association of critically short telomeres with brain and blood markers of ageing and Alzheimer's disease in older adults. Alzheimers Res Ther. 2024 Dec 20;16(1):269. doi: 10.1186/s13195-024-01635-0.
PubMed 39707531Garnier-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.
PubMed 39550530Requier F, Demnitz-King H, Frison E, Delarue M, Gonneaud J, Chetelat G, Klimecki O, Salmon E, Lutz A, Marchant NL, Collette F; Medit-Ageing Research Group. The evolution of subjective cognition after meditation training in older people: a secondary analysis of the three-arm age-well randomized controlled trial. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2025 Mar;32(2):252-269. doi: 10.1080/13825585.2024.2376783. Epub 2024 Jul 17.
PubMed 39017643Champetier 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.
PubMed 38227830
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training and Foreign Language Learning on Behavioral, Biological and Neuroimaging Measures
- ClinicalTrials.gov ID
- NCT02977819
- Acronym / sponsor ID
- Age-Well / C16-38
- Conditions
- Cognitive Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 24 Nov 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 9 Dec 2023 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Understanding of the neurocognitive mechanisms of meditation is still limited. Meditation can be conceptualized as "a set of complex emotional and attentional regulation strategies developed for a variety of purposes including the development of emotional well-being and balance". Affective (emotional) and cognitive (attentional) control are therefore the most likely mechanisms by which meditation could impact aging and AD. Specifically, meditation could enhance the controlling role of mid-brain structures and the executive network over structures involved in memory, emotions, and regulation of the immune system. This would lead to better emotional and cognitive control which in turn would be associated with improved mental and physical health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meditation program | Experimental | Other: Meditation practiceMeditation courses and at-home practice |
| English learning courses | Active comparator | Other: Learning English as a foreign languageEnglish learning courses and at-home practice |
| No intervention | No intervention | –Follow-up without Meditation courses or English Learning courses |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation practice18 months | Other | Meditation program |
| Learning English as a foreign language18 months | Other | English learning courses |
Primary outcome
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
Time frame: Visit 1 inclusion - Visit 3 Month 18
change in anterior cingulate cortex volume (T1-weighted MRI)
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
Time frame: Visit 1 inclusion - Visit 3 Month 18
change in anterior cingulate cortex perfusion (early PET-Amyvid® scan)
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
Time frame: Visit 1 inclusion - Visit 3 Month 18
change in insula volume (T1-weighted MRI)
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
Time frame: Visit 1 inclusion - Visit 3 Month 18
change in insula perfusion (early PET-Amyvid® scan)
35 secondary outcomes
Comparison between meditation intervention and language learning intervention on the global metacognitive composite score
Time frame: up to 35 months post intervention
Composite score per cognitive area assessed by the neuropsychological tests and the questionnaires
Time frame: up to 35 months post intervention
Medical neuroimaging using MRI: grey and white matter volume in all brain voxels
Time frame: up to 35 months post intervention
Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes
Time frame: up to 35 months post intervention
Medical neuroimaging using MRI: brain perfusion in all brain voxels
Time frame: up to 35 months post intervention
Medical neuroimaging using MRI: fractional anisotropy and mean diffusivity in all brain voxels
Time frame: up to 35 months post intervention
Medical neuroimaging using MRI: number, size, type and location of white matter lesions
Time frame: up to 35 months post intervention
Medical neuroimaging using MRI: magnetic susceptibility index in all brain voxels
Time frame: up to 35 months post intervention
Medical neuroimaging using MRI: brain functional connectivity measures in all brain voxels at rest in a non-meditative state
Time frame: up to 35 months post intervention
Beta-amyloid charge (of the radiopharmarceutical Amyvid®) measured in each voxel of the brain and gross mean in gray matter
Time frame: up to 35 months post intervention
Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum)
Time frame: up to 35 months post intervention
Medical neuroimaging using fMRI: Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task.
Time frame: up to 35 months post intervention
Medical neuroimaging using fMRI: Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task.
Time frame: up to 35 months post intervention
Medical neuroimaging using PET-scan and Amyvid® radiotracer
Time frame: up to 35 months post intervention
Subjectives sleep measures with sleep quality index z-score mean of the scores at questionnaires
Time frame: up to 35 months post intervention
Mean duration of sleep
Time frame: up to 35 months post intervention
fragmentation indices during activity and resting states
Time frame: up to 35 months post intervention
regularity of the rest-activity cycle
Time frame: up to 35 months post intervention
Mean z-score of total sleep time
Time frame: up to 35 months post intervention
Mean z-score of sleep onset latency
Time frame: up to 35 months post intervention
Mean z-score of sleep efficiency
Time frame: up to 35 months post intervention
Biological blood tests
Time frame: up to 35 months post intervention
Telomerase properties by blood tests
Time frame: visit 1 baseline -Visit 3 18 months
lymphocytic immunophenotyping
Time frame: visit 1 baseline -Visit 3 18 months
Difference in partner perceptions of participant mindfulness measured by Five-Facet Mindfulness Questionnaire (FFMQ-15, range 15-75, higher scores indicate greater mindfulness)
Time frame: up to 35 months post intervention
Difference in partner perceptions of participant compassion towards others measured by Compassionate Love Scale (Range 21-147, higher scores indicate greater compassion)
Time frame: up to 35 months post intervention
Difference in partner perceptions of participant depression measured by the Geriatric Depression Scale (range 0-15, higher scores indicate greater depressive symptoms)
Time frame: up to 35 months post intervention
Scores to evaluate the impact on volunteers' relatives
Time frame: up to 35 months post intervention
Difference in partner perceptions of participant anxiety measured by trait subscale of the state-trait anxiety inventory (trait-STAI, range 20-80, higher scores indicate greater anxiety symptoms)
Time frame: up to 35 months post intervention
Difference in partner perceptions of participant prosocialness measured by Prosocialness scale (range 16-80, higher scores indicate greater prosocialness)
Time frame: up to 35 months post intervention
Difference in partner perceptions of participant's cognitive difficulties in everyday life, measured by Mc Nair CDS (range 0-156, higher score indicates greater cognitive difficulties)
Time frame: up to 35 months post intervention
Neural signature of meditative practices using brain medical imaging (neuronal activity in each cerebral voxel (fMRI) at rest and during the emotional task, in a mindfulness meditative state versus not; in compasional meditative state or not)
Time frame: up to 35 months post intervention
Safety and acceptance
Time frame: up to 35 months post intervention
evaluation of the practice of the meditation practice and language learning at long-term (29 months post-intervention)
Time frame: up to 35 months post intervention (because V4 = 29 months post intervention with a window of 6 months
Behavioral measures (questionnaires) to evaluate the psychological impact of the confinement
Time frame: up to 35 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 30581977Poisnel 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.
- Results publication: PubMed 36215061Chetelat 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.
- Results publication: PubMed 38039341Schlosser 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.
- Derived from this study: PubMed 41996149Montagne B, Boulin M, Hamel A, Champetier P, Rehel S, Mezenge F, Landeau B, Delarue M, Hebert O, Soussi C, Bertran F, Chetelat G, Andre C, Rauchs G; Medit-Ageing Research Group. Night-to-night rapid eye movement sleep variability: A relevant marker of early amyloid-beta deposition. Alzheimers Dement. 2026 Apr;22(4):e71376. doi: 10.1002/alz.71376.
- Derived from this study: PubMed 41772375Foyard E, Blanchard T, Landeau B, Chauveau L, Naveau M, Poisnel G, Bui E, Chetelat G, de Flores R; Medit-Ageing Research Group. Altered locus coeruleus links to atrophy and hypometabolism in individuals with high Alzheimer's disease biomarkers. Alzheimers Dement. 2026 Mar;22(3):e71212. doi: 10.1002/alz.71212.
- Derived from this study: PubMed 41345970Lehodey A, Montagne B, Rehel S, Kaliman P, Chocat A, Mezenge F, Landeau B, de la Sayette V, Chetelat G, Rauchs G, Poisnel G; Medit-Ageing Research Group. Telomere dynamics are influenced by sleep, sleep variability and circadian rhythms in older adults with or without alzheimer's risk. Alzheimers Res Ther. 2025 Dec 5;18(1):10. doi: 10.1186/s13195-025-01923-3.
- Derived from this study: PubMed 40800757Haudry 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.
- Derived from this study: PubMed 40731281Champetier 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. 2026 Apr;35(2):e70161. doi: 10.1111/jsr.70161. Epub 2025 Jul 29.
- Derived from this study: PubMed 40665410Chauveau 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.
- Derived from this study: PubMed 40374672Requier 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.
- Derived from this study: PubMed 39762947Touron 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.
- Derived from this study: PubMed 39707531Lehodey A, Kaliman P, Palix C, de Flores R, Touron E, Turpin AL, Fauvel S, Mezenge F, Landeau B, Chocat A, Vrillon A, Paquet C, Vivien D, de La Sayette V, Chetelat G, Poisnel G; Medit-Ageing Research Group. Association of critically short telomeres with brain and blood markers of ageing and Alzheimer's disease in older adults. Alzheimers Res Ther. 2024 Dec 20;16(1):269. doi: 10.1186/s13195-024-01635-0.
- Individual participant dataSharing planned: Yes. Data access of AGE-WELL and SCD-WELL studies of the MEDIT-AGEING project for which Institut national de la santé et de la recherche médicale (Inserm) is the sponsor. The Material can be mobilized, under the conditions and modalities defined in the Charter, by any research team belonging to an Academic signatory to the Consortium Agreement concluded for the needs of the Project or by any research team belonging to an Academic outside the Consortium Agreement, French or foreign, for carrying out SRP relating to the scientific theme of mental health and wellbeing in older people. The Material may also be mobilized, by non-academic third parties for the realization of SRP relating to the scientific theme of mental health and wellbeing in older people, under conditions, in particular financial, which will be established by separate agreement between Inserm and by the said third party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
De La Sayette Vincent principal investigator
CHU Caen - France
Chételat Gaël study director
GIP Cyceron Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation practice and Learning English as a foreign language in people with Cognitive Aging, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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?
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 (time frame: Visit 1 inclusion - Visit 3 Month 18). The study lists 4 primary outcomes in all. 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 NCT02977819, which also lists 22 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 10 Feb 2025.