REMINDER program: a randomized controlled trial protocol of a neuropsychological intervention for lifestyle modification in older adults at risk of dementia

Background 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 to increase at-risk older adults’ competence in terms of cognitive reserve, socialization and emotion regulation skills and goal setting/goal-monitoring; within the framework of the dementia prevention available guidelines. Aims This manuscript aim is to present the protocol for two randomized controlled trials for the validation of the REMINDER program. Methods The REMINDER study will a Community Trial (cognitively unimpaired older adults at risk; N = 270) and a Clinical Trial (individuals with Mild Cognitive Impairment; N = 270). The Clinical Trial will include an additional harm that combines caregivers’ education and support with the REMINDER program. Participants will take part of the REMINDER program for 20 sessions and complete pre/post and follow-up outcome assessment measures. This neuropsychologist-led group program include education, experiential/reflective and practice moments, including behavior modification techniques throughout the modules. Primary outcomes will be a cognitive function and healthy lifestyle behavior. Secondary outcomes include performance in specific cognitive functions, functional status, psychosocial/mental health indicators and blood-based markers of neurodegeneration. Conclusions Part of the World-Wide FINGERS network, the REMINDER program aims to contribute with the inclusion of goal monitoring, emotion regulation techniques, peer support and other behavioral techniques in a dementia prevention trial, fostering engagement and long-term adherence to protective lifestyles across the dementia risk continuum. Trial registration ClinicalTrial.gov Identifier NCT05296980