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Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training (Age-Well)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02977819
Recruitment Status : Active, not recruiting
First Posted : November 30, 2016
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Cognitive Aging Other: Meditation practice Other: Learning English as a foreign language Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 24, 2016
Estimated Primary Completion Date : September 23, 2021
Estimated Study Completion Date : November 23, 2022

Arm Intervention/treatment
Experimental: Meditation program
Meditation courses and at-home practice
Other: Meditation practice
18 months

Active Comparator: English learning courses
English learning courses and at-home practice
Other: Learning English as a foreign language
18 months

No Intervention: No intervention
Follow-up without Meditation courses or English Learning courses



Primary Outcome Measures :
  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 Outcome Measures :
  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...)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  1. 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)
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977819


Locations
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France
GIP Cyceron
Caen, Calvados, France, 14000
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: De La Sayette Vincent CHU Caen - France
Study Director: Chételat Gaël GIP Cyceron Caen
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02977819    
Other Study ID Numbers: C16-38
2016-A01767-44 ( Registry Identifier: ID RCB )
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: 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.
URL: https://silversantestudy.fr/