NCT02977819 · COMPLETED
Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training
This trial is testing whether regular meditation practice can support healthy cognitive aging in adults 65 and older who currently have no memory problems. It compares meditators to a control group learning English as a foreign language, tracking brain and cognitive changes over 24 months. This is a Phase NA study — meaning it is a structured research trial but not a drug trial, so there is no drug approval process involved.
Eligibility 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.The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-02-10