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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
137
18 months
18 months
GIP Cyceron
Caen, Calvados, France
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Visit 1 inclusion - Visit 3 Month 18
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)
Time frame: 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.
Time frame: 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
Time frame: up to 35 months post intervention
Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes
hippocampal and hippocampal subfield volumes
Time frame: up to 35 months post intervention
Medical neuroimaging using MRI: brain perfusion in all brain voxels
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
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
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
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
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
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)
Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum) by TEP
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.
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.
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
Brain amyloid load (of the PET-Amyvid® radiotracer) measured in global grey matter mask
Time frame: 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.
Time frame: up to 35 months post intervention
Mean duration of sleep
Data collected by actimetrics record
Time frame: up to 35 months post intervention
fragmentation indices during activity and resting states
Data collected by actimetrics record
Time frame: up to 35 months post intervention
regularity of the rest-activity cycle
Data collected by actimetrics record
Time frame: up to 35 months post intervention
Mean z-score of total sleep time
Data collected during polysomnographic sleep record with Somno-Art device
Time frame: up to 35 months post intervention
Mean z-score of sleep onset latency
Data collected during polysomnographic sleep record with Somno-Art device
Time frame: up to 35 months post intervention
Mean z-score of sleep efficiency
Data collected during polysomnographic sleep record with Somno-Art device
Time frame: 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
Time frame: up to 35 months post intervention
Telomerase properties by blood tests
Telomerasic activity, telomerase length
Time frame: visit 1 baseline -Visit 3 18 months
lymphocytic immunophenotyping
biological blood tests
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)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant.
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)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
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)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Time frame: 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
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)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
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)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
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)
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
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)
only for meditation experts
Time frame: up to 35 months post intervention
Safety and acceptance
recording adverse events, measurement of anxiety, depression, satisfaction, and well-being using questionnaires
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)
questionnaire about the practice (meditation or foreign language)
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
composite score per function (anxiety, stress, auto-compassion...)
Time frame: up to 35 months post intervention
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