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

Cognitive Aging Clinical Trial

— Age-Well  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02977819
• Other study ID #: C16-38
• Secondary ID: 2016-A01767-44
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 24, 2016
• Est. completion date: November 23, 2022

Study information

• Verified date: February 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 137
• Est. completion date: November 23, 2022
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Aging

Intervention

Other:
• Meditation practice
18 months
• Learning English as a foreign language
18 months

Locations

Country	Name	City	State
France	GIP Cyceron	Caen	Calvados

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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, Chételat 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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)	up to 35 months post intervention
Secondary	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.	up to 35 months post intervention
Secondary	Medical neuroimaging using MRI: grey and white matter volume in all brain voxels	grey and white matter volume in all brain voxels	up to 35 months post intervention
Secondary	Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes	hippocampal and hippocampal subfield volumes	up to 35 months post intervention
Secondary	Medical neuroimaging using MRI: brain perfusion in all brain voxels	brain perfusion in all brain voxels	up to 35 months post intervention
Secondary	Medical neuroimaging using MRI: fractional anisotropy and mean diffusivity in all brain voxels	fractional anisotropy and mean diffusivity in all brain voxels	up to 35 months post intervention
Secondary	Medical neuroimaging using MRI: number, size, type and location of white matter lesions	number, size, type and location of white matter lesions	up to 35 months post intervention
Secondary	Medical neuroimaging using MRI: magnetic susceptibility index in all brain voxels	magnetic susceptibility index in all brain voxels	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	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.	up to 35 months post intervention
Secondary	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.	up to 35 months post intervention
Secondary	Medical neuroimaging using PET-scan and Amyvid® radiotracer	Brain amyloid load (of the PET-Amyvid® radiotracer) measured in global grey matter mask	up to 35 months post intervention
Secondary	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.	up to 35 months post intervention
Secondary	Mean duration of sleep	Data collected by actimetrics record	up to 35 months post intervention
Secondary	fragmentation indices during activity and resting states	Data collected by actimetrics record	up to 35 months post intervention
Secondary	regularity of the rest-activity cycle	Data collected by actimetrics record	up to 35 months post intervention
Secondary	Mean z-score of total sleep time	Data collected during polysomnographic sleep record with Somno-Art device	up to 35 months post intervention
Secondary	Mean z-score of sleep onset latency	Data collected during polysomnographic sleep record with Somno-Art device	up to 35 months post intervention
Secondary	Mean z-score of sleep efficiency	Data collected during polysomnographic sleep record with Somno-Art device	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	Telomerase properties by blood tests	Telomerasic activity, telomerase length	visit 1 baseline -Visit 3 18 months
Secondary	lymphocytic immunophenotyping	biological blood tests	visit 1 baseline -Visit 3 18 months
Secondary	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.	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	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	up to 35 months post intervention
Secondary	Safety and acceptance	recording adverse events, measurement of anxiety, depression, satisfaction, and well-being using questionnaires	up to 35 months post intervention
Secondary	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)	up to 35 months post intervention (because V4 = 29 months post intervention with a window of 6 months
Secondary	Behavioral measures (questionnaires) to evaluate the psychological impact of the confinement	composite score per function (anxiety, stress, auto-compassion...)	up to 35 months post intervention