CONSORT Diagram of Study Enrollment and Randomization
amyotrophic lateral sclerosis, dementia, loss of consciousness, head trauma
AMYOTROPHIC LATERAL SCLEROSIS, AMYLOID DEPOSITION, REGRESSIONS, SECONDARY, AMYLOID DEPOSITION
Of the 137 randomized participants, 2 were excluded by the trial steering committee from all secondary analyses for not meeting eligibility criteria (1 participant had history of head trauma [loss of consciousness for 1 hour or longer] and 1 participant received a clinical diagnosis of amyotrophic lateral sclerosis between the 9-month and postintervention visits, with a likely subclinical state at inclusion). Furthermore, 1 participant died during the follow-up (their data was included in mixed effects models for estimating intercepts only), and 1 participant revealed that they had not followed their allocated arm (randomized to no intervention but attended non-native language training and was analyzed within the non-native language training arm). CONSORT indicates Consolidated Standards of Reporting Trials; MRI, magnetic resonance imaging.Mixed effects models with participant-level random intercepts, estimated via restricted maximum likelihood, were fitted for each cognitive composite. Intervention effects were evaluated through the interaction between visit and trial arm. Post-hoc pairwise comparisons and within-arm changes were also examined. For all analyses baseline age, sex, and education level were included as fixed effects, with continuous variables mean-centered.Amyloid deposition, a dementia risk marker known to affect cognition, was added as a fixed effect in a sensitivity analysis. Additional sensitivity analyses assessed intervention effects for participants who attended 20% or more of intervention classes (the a priori determined adequate minimum doseExploratory analyses further examined associations between participant characteristics and change in cognition. Adjusted linear regressions were conducted separately in the meditation and non-native language training arms, with change in composite scores as the outcome and the variable of interest (ie, age, sex, education, apolipoprotein ε4 status, amyloid deposition, vascular risk, credibility, expectancy, practice, responsiveness, and baseline composite scores) as the predictor. Variables were chosen based on association with dementia risk or potential to affect intervention engagement. In France, there are strict ethical restrictions about asking participants for their race and ethnicity. We did not receive ethical approval to do so, therefore we did not include race and ethnicity as a variable in this study.Analyses were conducted in R version 4.0.2 (R Foundation for Statistical Computing), utilizing the 