Validation of the REMINDER Dementia Risk Reduction Program
NCT ID: NCT05296980
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2022-04-01
2026-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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REMINDER program online
The REMINDER program in this arm will be delivered by videoconferencing. It will integrate 20 sessions (with approximate length of 45-60 min), therapist-mediated, carried out twice a week, over a period of 12 weeks. Psychoeducation sessions and part of the reminiscence and memory strategies training sessions will be facilitated in groups, as means to promote social support and modeling, and the remaining will be individual sessions. Several activities aimed to promote personal development and definition and achievement of meaningful goals will be included in the program, and the program will be manualized to facilitate its future dissemination and implementation
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.
REMINDER program face-to-face
The REMINDER program in this arm will be delivered face to face. It will integrate 20 sessions (with approximate length of 45-60 min), therapist-mediated, carried out twice a week, over a period of 12 weeks. Psychoeducation sessions and part of the reminiscence and memory strategies training sessions will be facilitated in groups, as means to promote social support and modeling, and the remaining will be individual sessions. Several activities aimed to promote personal development and definition and achievement of meaningful goals will be included in the program, and the program will be manualized to facilitate its future dissemination and implementation
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.
Brain psychoeducation program
The control condition will have the same length as the experimental harms, including 20 psychoeducation sessions, with information regarding dementia modifiable risk factors, information on healthy lifestyles, and brain health promotion.
Brain health Psychoeducation
Delivery of psychoeducation sessions about dementia modifiable risk factors, brain health solutions and lifestyle change tips.
Interventions
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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.
Brain health Psychoeducation
Delivery of psychoeducation sessions about dementia modifiable risk factors, brain health solutions and lifestyle change tips.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* Presence of any neurological event in their medical history that could compromise actual cognition.
60 Years
75 Years
ALL
Yes
Sponsors
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Fundação para a Ciência e a Tecnologia
OTHER
University of Coimbra
OTHER
Responsible Party
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Ana Rita Silva
Principal Investigator
Locations
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Faculty of Psychology and Educational Sciences
Coimbra, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REMINDER
Identifier Type: -
Identifier Source: org_study_id
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