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NCT Number: NCT05296980

Validation of the REMINDER Dementia Risk Reduction Program

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.

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Key information

Conditions

Healthy Aging Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Old Age; Dementia Risk Reduction Risk Reduction Behavior Tauopathies

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Psychology and Educational Sciences

Coimbra, 3002-115, Portugal

Location status: Recruiting

Location contact

FPCEUC

CONTACT

[email protected]

00351239 851 450

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reminder

Behavioral

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

Behavioral

Delivery of psychoeducation sessions about dementia modifiable risk factors, brain health solutions and lifestyle change tips.

Primary outcomes

  1. Cognitive status composite

    Time frame: Post intervention (1 week after the intervention sessions completion)

    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.

  2. Functionality status

    Time frame: Post intervention (1 week after the intervention sessions completion)

    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.

  3. Blood biomarkers of neural damage

    Time frame: Post intervention (1 week after the intervention sessions completion)

    blood Neurofilament light chain (NfL) will be measured and tested as an outcome immediately after the intervention

  4. Cognitive status composite

    Time frame: Follow - up (12 months after the intervention)

    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

  5. Functionality status

    Time frame: Follow - up (12 months after the intervention)

    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.

  6. Cognitive status composite

    Time frame: Follow - up (24 months after the intervention)

    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

  7. Functionality status

    Time frame: Follow - up (24 months after the intervention)

    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.

Secondary outcomes

  1. Brain changes

    Time frame: Post intervention (2 weeks after the intervention sessions completion)

    hippocampus volume and DMN connectivity will be measured pre and post intervention in the RCT phase

  2. Mood status

    Time frame: Post intervention (1 week after the intervention sessions completion)

    The Geriatric Depression Scale Short Form (GDS-15) (0-15, with higher scores meaning worse outcomes) and and The Geriatric Anxiety Inventory- Short Form (GAI-SF, 0-5, with higher scores meaning worse outcome) scores will be measured

  3. Mood status

    Time frame: Follow-up (12 months after the intervention)

    The Geriatric Depression Scale Short Form (GDS-15) (0-15, with higher scores meaning worse outcomes) and and The Geriatric Anxiety Inventory- Short Form (GAI-SF, 0-5, with higher scores meaning worse outcome) scores will be measured.

  4. Perceived quality of life

    Time frame: Post intervention (1 week after the intervention sessions completion)

    A measure of quality of life - World Health Organization Quality of Life - Old WHOQOL-OLD)will be incorporated to examine the effects of the program in self perceptions of well being. Higher scores mean better outcome

  5. Perceived quality of life

    Time frame: Follow-up (12 months after the intervention)

    A measure of quality of life - World Health Organization Quality of Life - Old WHOQOL-OLD)will be incorporated to examine the effects of the program in self perceptions of well being. Higher scores mean better outcome

  6. Perceived Self Efficacy

    Time frame: Post intervention (1 week after the intervention sessions completion)

    A measure of self efficacy - Self Efficacy for Meaningful Activities (SEMActiv) will be implemented to examine self-efficacy, with higher scores meaning better outcome

  7. Perceived Self Efficacy

    Time frame: Follow-up (12 months after the intervention)

    A measure of self efficacy - Self Efficacy for Meaningful Activities (SEMActiv) will be implemented to examine self-efficacy, with higher scores meaning better outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Rita Silva, PhD

CONTACT

[email protected]

+351962779695

University of Coimbra

CONTACT

[email protected]

+351 239851450

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia

Registry information

Official study title

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

Acronym: REMINDER

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Mar 25, 2022
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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