Clinical trial NCT05296980: Validation of the REMINDER Dementia Risk Reduction Program
Official title: Validation of a Multidomain Neuropsychological Intervention for Individuals at Risk of Dementia: the REMINDER Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Aging
Risk Reduction
Old Age; Dementia
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2022-03-25
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 60 or older
* CAIDE dementia risk score \>8
* Cognitive function: absence of significant cognitive impairment as per the Addenbrooke's Cognitive Examination-REVISED
* Free of physical disabilities that preclude participation in the study
* Willing to complete all study-related activities for 12 weeks

Exclusion Criteria:

* Mild cognitive impairment or dementia;
* Presence of any neurological event in their medical history that could compromise actual cognition.
* Presence of any severe psychiatric disorder (mild depressive and anxiety symptoms meet inclusion criteria).
* Unability to travel to the site where the sessions will be delivered (if so randomization will be circumscribed between the experimental harm REMINDER online and the control group.
* Illiteracy

Primary outcomes:
measure: Cognitive status composite
timeFrame: Post intervention (1 week after the intervention sessions completion)
measure: Functionality status
timeFrame: Post intervention (1 week after the intervention sessions completion)
measure: Blood biomarkers of neural damage
timeFrame: Post intervention (1 week after the intervention sessions completion)
measure: Cognitive status composite
timeFrame: Follow - up (12 months after the intervention)
measure: Functionality status
timeFrame: Follow - up (12 months after the intervention)
measure: Cognitive status composite
timeFrame: Follow - up (24 months after the intervention)
measure: Functionality status
timeFrame: Follow - up (24 months after the intervention)
Secondary outcomes:
measure: Brain changes
timeFrame: Post intervention (2 weeks after the intervention sessions completion)
measure: Mood status
timeFrame: Post intervention (1 week after the intervention sessions completion)
measure: Mood status
timeFrame: Follow-up (12 months after the intervention)
measure: Perceived quality of life
timeFrame: Post intervention (1 week after the intervention sessions completion)
measure: Perceived quality of life
timeFrame: Follow-up (12 months after the intervention)
measure: Perceived Self Efficacy
timeFrame: Post intervention (1 week after the intervention sessions completion)
measure: Perceived Self Efficacy
timeFrame: Follow-up (12 months after the intervention)
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Psychology and Educational Sciences
Study officials:
References: