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Recruiting NCT05296980

Validation of the REMINDER Dementia Risk Reduction Program

No phase Interventional Healthy Aging Risk Reduction Old Age; Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REMINDER, Brain health Psychoeducation.
Who it may be relevant to
Registry conditions: Healthy Aging, Risk Reduction, Old Age; Dementia. Basic parameters: 60 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Cognitive status composite [Time frame: Post intervention (1 week after the intervention sessions completion)]
  • Functionality status [Time frame: Post intervention (1 week after the intervention sessions completion)]
  • Blood biomarkers of neural damage [Time frame: Post intervention (1 week after the intervention sessions completion)]
  • Cognitive status composite [Time frame: Follow - up (12 months after the intervention)]
  • Functionality status [Time frame: Follow - up (12 months after the intervention)]
  • Cognitive status composite [Time frame: Follow - up (24 months after the intervention)]
  • Functionality status [Time frame: Follow - up (24 months after the intervention)]
Secondary outcome measures (7)
  • Brain changes [Time frame: Post intervention (2 weeks after the intervention sessions completion)]
  • Mood status [Time frame: Post intervention (1 week after the intervention sessions completion)]
  • Mood status [Time frame: Follow-up (12 months after the intervention)]
  • Perceived quality of life [Time frame: Post intervention (1 week after the intervention sessions completion)]
  • Perceived quality of life [Time frame: Follow-up (12 months after the intervention)]
  • Perceived Self Efficacy [Time frame: Post intervention (1 week after the intervention sessions completion)]
  • Perceived Self Efficacy [Time frame: Follow-up (12 months after the intervention)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Prevention

Study locations

Portugal · 1 center
  • Faculty of Psychology and Educational Sciences — Coimbra

Publications

  • 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;26(1):48. doi: 10.1186/s12877-025-06714-x. PMID 41366742

Identifiers

NCT: NCT05296980 · REMINDER

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗