NCT05296980

Validation of the REMINDER Dementia Risk Reduction Program

Validation of a Multidomain Neuropsychological Intervention for Individuals at Risk of Dementia: the REMINDER Program

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University of Coimbra · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Until now, neuropsychological interventions aimed to optimize cognitive function and to have functional impact in individuals at risk of AD (MCI patients) were scarce in validity studies. While some RCTs have been developed in cognitive training interventions, comparative studies of merged interventions (cognitive, social and behavioral stimulation) with adequate control groups are absent, diminishing the professionals' trust on the adoption of these interventions for supporting patients. As such, the present proposal will develop a validation trial testing a multicomponent neuropsychological intervention (REMINDER), based on personal development, cognitive compensatory aids, meaningful goals setting, and behavior change techniques. The investigators will analyze its short/long-term gains and AD conversion rates. By aiming to provide a good validation study for REMINDER, the investigators will examine neurobiological, neurocognitive and functional outcomes of this intervention in comparison with an active control group (psychoeducation) in order to foster an effective outcome assessment of an intervention for individuals at risk of AD.

Detailed description

The overarching tenet of this project is that, by providing a manualized multidomain intervention - REMINDER - that engages at risk individuals in the aims of this protocol, it can have a significant impact on health outcomes, optimizing healthier lifestyles and these being also understood along with the neurodegeneration signs of this impact. The specific aims of this study will be: * Recruit community-dwelling individuals with increased risk of dementia using CAIDE dementia risk score (with APOE, when available). * Evaluate the REMINDER program (in comparison to an active control group (CT) - psychoeducation sessions) immediate effects regarding global cognition and functionality (primary outcomes) and neuropsychological, biochemical and neuroimaging outcomes (secondary outcomes). * Determine the persistence of effects and begin characterizing the temporal course of putative benefits at 6-, and 18-months follow-up. * Investigate the role of biomarkers (imaging and biochemical) in explaining the response to intervention and persistence of the effects and its correlation with neuropsychological and functionality measures. * Measure the conversion rates from MCI to AD between the REMINDER and active control groups (at 24- months follow-up). Our ultimate goal is to make available a scientifically validated and scalable intervention that helps prevent dementia in older adults at risk. By confirming the efficacy of REMINDER to prevent cognitive impairment and concluding for its medium-term efficacy to improve global cognitive function and healthy life habits the investigators are contributing to one of the WHO goals (Goal 3 - ensure healthy lives and promote well-being for all at all ages) by addressing risk reduction and management of a global health risk.

Conditions

• Healthy Aging
• Risk Reduction
• Old Age; Dementia

Interventions

Type	Name	Description
BEHAVIORAL	REMINDER	The REMINDER program is a therapist-mediated manualized neuropsychological intervention, involving training skills to stimulate cognitive reserve, socialization and personal development, to diminish the risk of cognitive decline.
BEHAVIORAL	Brain health Psychoeducation	Delivery of psychoeducation sessions about dementia modifiable risk factors, brain health solutions and lifestyle change tips.

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-05-02
• Completion: 2026-10-01
• First posted: 2022-03-25
• Last updated: 2024-05-08

Locations

1 site across 1 country: Portugal