Validation of the REMINDER Dementia Risk Reduction Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-75
SponsorUniversity of Coimbra
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
REMINDER
BehavioralThe 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
BehavioralDelivery of psychoeducation sessions about dementia modifiable risk factors, brain health solutions and lifestyle change tips.
Treatment groups
400 Participants
are divided into 3 treatment groupsGroup A: REMINDER program onlineExperimental treatment 1 intervention
Group B: REMINDER program face-to-faceExperimental treatment 1 intervention
Group C: Brain psychoeducation programSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Post intervention (1 week after the intervention sessions completion)2
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.
Time frame
Post intervention (1 week after the intervention sessions completion)3
Blood biomarkers of neural damage
blood Neurofilament light chain (NfL) will be measured and tested as an outcome immediately after the intervention
Time frame
Post intervention (1 week after the intervention sessions completion)4
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
Time frame
Follow - up (12 months after the intervention)Secondary outcomes
1
Brain changes
hippocampus volume and DMN connectivity will be measured pre and post intervention in the RCT phase
Time frame
Post intervention (2 weeks after the intervention sessions completion)2
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
Time frame
Post intervention (1 week after the intervention sessions completion)3
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.
Time frame
Follow-up (12 months after the intervention)4
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
Time frame
Post intervention (1 week after the intervention sessions completion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Coimbra
Lead sponsor
Fundação para a Ciência e a Tecnologia
Collaborator
Source ClinicalTrials.gov