GIP Cyceron
Caen, Calvados, 14000, France
NCT Number: NCT02977819
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Caen, Calvados, 14000, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
For all participants
For participants without previous meditation practice
For expert meditators :
18 months
18 months
Time frame: Visit 1 inclusion - Visit 3 Month 18
change in anterior cingulate cortex volume (T1-weighted MRI)
Time frame: Visit 1 inclusion - Visit 3 Month 18
change in anterior cingulate cortex perfusion (early PET-Amyvid® scan)
Time frame: Visit 1 inclusion - Visit 3 Month 18
change in insula volume (T1-weighted MRI)
Time frame: Visit 1 inclusion - Visit 3 Month 18
change in insula perfusion (early PET-Amyvid® scan)
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)
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.
Time frame: up to 35 months post intervention
grey and white matter volume in all brain voxels
Time frame: up to 35 months post intervention
hippocampal and hippocampal subfield volumes
Time frame: up to 35 months post intervention
brain perfusion in all brain voxels
Time frame: up to 35 months post intervention
fractional anisotropy and mean diffusivity in all brain voxels
Time frame: up to 35 months post intervention
number, size, type and location of white matter lesions
Time frame: up to 35 months post intervention
magnetic susceptibility index in all brain voxels
Time frame: up to 35 months post intervention
brain functional connectivity measures in all brain voxels at rest in a non-meditative state
Time frame: up to 35 months post intervention
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) by TEP
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.
Time frame: up to 35 months post intervention
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 amyloid load (of the PET-Amyvid® radiotracer) measured in global grey matter mask
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.
Time frame: up to 35 months post intervention
Data collected by actimetrics record
Time frame: up to 35 months post intervention
Data collected by actimetrics record
Time frame: up to 35 months post intervention
Data collected by actimetrics record
Time frame: up to 35 months post intervention
Data collected during polysomnographic sleep record with Somno-Art device
Time frame: up to 35 months post intervention
Data collected during polysomnographic sleep record with Somno-Art device
Time frame: up to 35 months post intervention
Data collected during polysomnographic sleep record with Somno-Art device
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
Time frame: visit 1 baseline -Visit 3 18 months
Telomerasic activity, telomerase length
Time frame: visit 1 baseline -Visit 3 18 months
biological blood tests
Time frame: up to 35 months post intervention
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant.
Time frame: up to 35 months post intervention
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Time frame: up to 35 months post intervention
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 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
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Time frame: up to 35 months post intervention
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Time frame: up to 35 months post intervention
Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Time frame: up to 35 months post intervention
only for meditation experts
Time frame: up to 35 months post intervention
recording adverse events, measurement of anxiety, depression, satisfaction, and well-being using questionnaires
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)
Time frame: up to 35 months post intervention
composite score per function (anxiety, stress, auto-compassion...)
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
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
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.
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