REMINDER program: a randomized controlled trial protocol of a neuropsychological intervention for lifestyle...

Most dementia risk reduction trials encompass interventions mostly focused in cognitive and health monitoring risk factors, with less focus is given to psychosocial risk factors (e.g. social isolation, depression, anxiety) which can contribute to impoverished engagement in brain protective lifestyles. The REMINDER program was designed as a multimodal intervention that integrates cognitive training, lifestyle psychoeducation, social engagement, emotion regulation, and goal setting, following the framework of internationally established dementia prevention guidelines.

This manuscript presents the protocol for two randomized controlled trials validating the REMINDER program in both community and clinical populations.

The REMINDER study includes a Community Trial (cognitively unimpaired at-risk older adults; N = 270) and a Clinical Trial (individuals with Mild Cognitive Impairment; N = 270). The Clinical Trial includes an additional arm combining caregiver education and support with the REMINDER program. Participants will attend 20 group sessions and complete pre-, post- and follow-up outcome assessments. The program is delivered by trained neuropsychologists to ensure fidelity and high-qualit implementation. Primary outcomes are global cognitive function (composite of MMSE, Word List Total Recall, Category Fluency total, and Trail Making Test Part B) and healthy lifestyle behaviors (HLAT). Secondary outcomes include additional cognitive measures (ACE-R, BRIEF-A, Digit Span), functional status (IAFAI, UPSA-Brief), psychosocial and mental health indicators (GDS-30, WHOQOL-OLD-7, LSNS-6, CORE, MCLHB-DRR), and blood-based markers of neurodegeneration (NfL, GFAP, sPDGFRβ). An exploratory outcome will monitor diagnostic transitions in the MCI subgroup (conversion to dementia) across the 18-month follow-up.

The REMINDER program contributes to dementia prevention research by combining cognitive, lifestyle, and psychosocial strategies within a group-based format, aiming to foster long-term adherence to brain-protective behaviors. Nevertheless, challenges are anticipated, including participant heterogeneity, adherence to lifestyle change, potential drop-out during follow-up, and the complexity of monitoring multiple outcomes. Addressing these limitations will be crucial to inform the future scalability and sustainability of dementia prevention interventions.

ClinicalTrial.gov Identifier NCT05296980, 22/02/2022).