Healthy Aging Clinical Trial
— REMINDEROfficial title:
Validation of a Multidomain Neuropsychological Intervention for Individuals at Risk of Dementia: the REMINDER Program
NCT number | NCT05296980 |
Other study ID # | REMINDER |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2022 |
Est. completion date | October 2026 |
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | October 2026 |
Est. primary completion date | May 2, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Portugal | Faculty of Psychology and Educational Sciences | Coimbra |
Lead Sponsor | Collaborator |
---|---|
University of Coimbra | Fundação para a Ciência e a Tecnologia |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Brain changes | hippocampus volume and DMN connectivity will be measured pre and post intervention in the RCT phase | Post intervention (2 weeks after the intervention sessions completion) | |
Secondary | Mood status | 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 | Post intervention (1 week after the intervention sessions completion) | |
Secondary | Mood status | 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. | Follow-up (12 months after the intervention) | |
Secondary | Perceived quality of life | 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 | Post intervention (1 week after the intervention sessions completion) | |
Secondary | Perceived quality of life | 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 | Follow-up (12 months after the intervention) | |
Secondary | Perceived Self Efficacy | A measure of self efficacy - Self Efficacy for Meaningful Activities (SEMActiv) will be implemented to examine self-efficacy, with higher scores meaning better outcome | Post intervention (1 week after the intervention sessions completion) | |
Secondary | Perceived Self Efficacy | A measure of self efficacy - Self Efficacy for Meaningful Activities (SEMActiv) will be implemented to examine self-efficacy, with higher scores meaning better outcome | Follow-up (12 months after the intervention) |
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