Skip to main content
OpenTrials
Completed

NCT Number: NCT02977819

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GIP Cyceron

Caen, Calvados, 14000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Meditation practice

Other

18 months

Learning English as a foreign language

Other

18 months

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

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

    Time frame: up to 35 months post intervention

    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)

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

    Time frame: up to 35 months post intervention

    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.

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

    Time frame: up to 35 months post intervention

    grey and white matter volume in all brain voxels

  4. Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes

    Time frame: up to 35 months post intervention

    hippocampal and hippocampal subfield volumes

  5. Medical neuroimaging using MRI: brain perfusion in all brain voxels

    Time frame: up to 35 months post intervention

    brain perfusion in all brain voxels

  6. Medical neuroimaging using MRI: fractional anisotropy and mean diffusivity in all brain voxels

    Time frame: up to 35 months post intervention

    fractional anisotropy and mean diffusivity in all brain voxels

  7. Medical neuroimaging using MRI: number, size, type and location of white matter lesions

    Time frame: up to 35 months post intervention

    number, size, type and location of white matter lesions

  8. Medical neuroimaging using MRI: magnetic susceptibility index in all brain voxels

    Time frame: up to 35 months post intervention

    magnetic susceptibility index in all brain voxels

  9. 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

    brain functional connectivity measures in all brain voxels at rest in a non-meditative state

  10. 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

    measured in each voxel of the brain and gross mean in gray matter

  11. Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum)

    Time frame: up to 35 months post intervention

    Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum) by TEP

  12. 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

    Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task.

  13. 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

    Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task.

  14. Medical neuroimaging using PET-scan and Amyvid® radiotracer

    Time frame: up to 35 months post intervention

    Brain amyloid load (of the PET-Amyvid® radiotracer) measured in global grey matter mask

  15. Subjectives sleep measures with sleep quality index z-score mean of the scores at questionnaires

    Time frame: up to 35 months post intervention

    Epworth scale, Leeds Sleep evaluation questionnaire, Pittsburg Sleep Quality Scale, St Mary's hospital questionnaire, Berlin Questionnaire, and Insomnia severity index.

  16. Mean duration of sleep

    Time frame: up to 35 months post intervention

    Data collected by actimetrics record

  17. fragmentation indices during activity and resting states

    Time frame: up to 35 months post intervention

    Data collected by actimetrics record

  18. regularity of the rest-activity cycle

    Time frame: up to 35 months post intervention

    Data collected by actimetrics record

  19. Mean z-score of total sleep time

    Time frame: up to 35 months post intervention

    Data collected during polysomnographic sleep record with Somno-Art device

  20. Mean z-score of sleep onset latency

    Time frame: up to 35 months post intervention

    Data collected during polysomnographic sleep record with Somno-Art device

  21. Mean z-score of sleep efficiency

    Time frame: up to 35 months post intervention

    Data collected during polysomnographic sleep record with Somno-Art device

  22. Biological blood tests

    Time frame: up to 35 months post intervention

    tau, phosphotau, Ab 40, 42, APOE4, NFL, BDNF, GWAS, cytokines, CRP, cortisol, serotonine, SDHEA, SHBG, E2, testosterone, glycemie, insuline, BNP, tPA, PAI-1, peroxyredoxine

  23. Telomerase properties by blood tests

    Time frame: visit 1 baseline -Visit 3 18 months

    Telomerasic activity, telomerase length

  24. lymphocytic immunophenotyping

    Time frame: visit 1 baseline -Visit 3 18 months

    biological blood tests

  25. 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

    Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant.

  26. 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

    Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant

  27. 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

    Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant

  28. Scores to evaluate the impact on volunteers' relatives

    Time frame: up to 35 months post intervention

    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

  29. 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

    Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant

  30. 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

    Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant

  31. 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

    Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant

  32. 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

    only for meditation experts

  33. Safety and acceptance

    Time frame: up to 35 months post intervention

    recording adverse events, measurement of anxiety, depression, satisfaction, and well-being using questionnaires

  34. 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

    questionnaire about the practice (meditation or foreign language)

  35. Behavioral measures (questionnaires) to evaluate the psychological impact of the confinement

    Time frame: up to 35 months post intervention

    composite score per function (anxiety, stress, auto-compassion...)

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study 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

Acronym: Age-Well

Important dates

Study start
2016
Primary completion
2019
Study completion
2023
First posted
Nov 30, 2016
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.