Validation of the REMINDER Dementia Risk Reduction Program
REMINDER
Validation of a Multidomain Neuropsychological Intervention for Individuals at Risk of Dementia: the REMINDER Program
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedMay 8, 2024
May 1, 2024
2.1 years
February 22, 2022
May 7, 2024
Conditions
Outcome Measures
Primary Outcomes (7)
Cognitive status composite
A composite score including the individual scores with Addenbrooke's Cognitive Examination - Revised (ACE-R) (0-100, higher scores meaning better outcome), that includes the Mini Mental State Examination - MMSE (0-30, with higher scores meaning better outcome), Subjective Cognitive Decline Questionnaire (SCDQ), Trail Making Test A and B (TMT A \& B), Verbal Fluency - Phonemic (P, M and R) and Categories (Animals), Stroop Test, Free and Cued Selective Reminding Test (FCSRT) will be generated to work as primary outcome.
Post intervention (1 week after the intervention sessions completion)
Functionality status
A composite score incorporating Adults and Older Adults Functional Assessment Inventory (IAFAI), University of California San Diego Performance-Based Skills Assessment (UPSA) will be used.
Post intervention (1 week after the intervention sessions completion)
Blood biomarkers of neural damage
blood Neurofilament light chain (NfL) will be measured and tested as an outcome immediately after the intervention
Post intervention (1 week after the intervention sessions completion)
Cognitive status composite
A composite score including the individual scores with Addenbrooke's Cognitive Examination - Revised (ACE-R), that includes the Mini Mental State Examination - MMSE (screening tools to consider eligibility), Subjective Cognitive Decline Questionnaire (SCDQ), Trail Making Test A and B (TMT A \& B), Verbal Fluency - Phonemic (P, M and R) and Categories (Animals), Stroop Test, Free and Cued Selective Reminding Test (FCSRT) will be generated to work as primary outcome
Follow - up (12 months after the intervention)
Functionality status
A composite score incorporating Adults and Older Adults Functional Assessment Inventory (IAFAI), University of California San Diego Performance-Based Skills Assessment (UPSA) will be used.
Follow - up (12 months after the intervention)
Cognitive status composite
A composite score including the individual scores with Addenbrooke's Cognitive Examination - Revised (ACE-R), that includes the Mini Mental State Examination - MMSE (screening tools to consider eligibility), Subjective Cognitive Decline Questionnaire (SCDQ), Trail Making Test A and B (TMT A \& B), Verbal Fluency - Phonemic (P, M and R) and Categories (Animals), Stroop Test, Free and Cued Selective Reminding Test (FCSRT) will be generated to work as primary outcome
Follow - up (24 months after the intervention)
Functionality status
A composite score incorporating Adults and Older Adults Functional Assessment Inventory (IAFAI), University of California San Diego Performance-Based Skills Assessment (UPSA) will be used.
Follow - up (24 months after the intervention)
Secondary Outcomes (7)
Brain changes
Post intervention (2 weeks after the intervention sessions completion)
Mood status
Post intervention (1 week after the intervention sessions completion)
Mood status
Follow-up (12 months after the intervention)
Perceived quality of life
Post intervention (1 week after the intervention sessions completion)
Perceived quality of life
Follow-up (12 months after the intervention)
- +2 more secondary outcomes
Study Arms (3)
REMINDER program online
EXPERIMENTALThe 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 program face-to-face
EXPERIMENTALThe 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
Brain psychoeducation program
SHAM COMPARATORThe 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.
Interventions
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.
Delivery of psychoeducation sessions about dementia modifiable risk factors, brain health solutions and lifestyle change tips.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Mild cognitive impairment or dementia;
- Presence of any neurological event in their medical history that could compromise actual cognition.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Coimbralead
- Fundação para a Ciência e a Tecnologiacollaborator
Study Sites (1)
Faculty of Psychology and Educational Sciences
Coimbra, 3002-115, Portugal
Related Publications (1)
Silva AR, Baptista C, Baldeiras I, Pinho MS, Lima M, Afonso RM. REMINDER program: a randomized controlled trial protocol of a neuropsychological intervention for lifestyle modification in older adults at risk of dementia. BMC Geriatr. 2025 Dec 10. doi: 10.1186/s12877-025-06714-x. Online ahead of print.
PMID: 41366742DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 22, 2022
First Posted
March 25, 2022
Study Start
April 1, 2022
Primary Completion
May 2, 2024
Study Completion (Estimated)
October 1, 2026
Last Updated
May 8, 2024
Record last verified: 2024-05