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Recruiting NCT05296980

NCT05296980 Validation of the REMINDER Dementia Risk Reduction Program

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Clinical Trial Summary
NCT ID NCT05296980
Status Recruiting
Phase
Sponsor University of Coimbra
Condition Healthy Aging
Study Type INTERVENTIONAL
Enrollment 400 participants
Start Date 2022-04-01
Primary Completion 2024-05-02

Eligibility & Interventions

Sex All sexes
Min Age 60 Years
Max Age 75 Years
Study Type INTERVENTIONAL
Interventions
REMINDERBrain health Psychoeducation

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 400 participants in total. It began in 2022-04-01 with a primary completion date of 2024-05-02.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Ana Rita Silva, PhD

✉ anaritaess@fpce.uc.pt

📞 +351962779695

Frequently Asked Questions

Who can join the NCT05296980 clinical trial?

This trial is open to participants of all sexes, aged 60 Years or older, up to 75 Years, studying Healthy Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05296980 currently recruiting?

Yes, NCT05296980 is actively recruiting participants. Contact the research team at anaritaess@fpce.uc.pt for enrollment information.

Where is the NCT05296980 trial being conducted?

This trial is being conducted at Coimbra, Portugal.

Who is sponsoring the NCT05296980 clinical trial?

NCT05296980 is sponsored by University of Coimbra. The trial plans to enroll 400 participants.

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