Validation of the REMINDER Dementia Risk Reduction Program

University of Coimbra

Status: Enrolling

Conditions: Old Age; Dementia; Risk Reduction; Healthy Aging

Treatments: Behavioral: REMINDER; Behavioral: Brain health Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT05296980

REMINDER (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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400 participants in 3 patient groups

REMINDER program online

Experimental group

Description:

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

Treatment:

Behavioral: REMINDER

REMINDER program face-to-face

Experimental group

Description:

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

Treatment:

Behavioral: REMINDER

Brain psychoeducation program

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Brain health Psychoeducation