The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-89
SponsorUniversity of Alabama at Birmingham
About this trial
Older adults at risk for dementia show a variety of cognitive deficits, which can be ameliorated by different cognitive training (CT) exercises. The best combination of CT exercises is unknown. The aim is to discover the most efficacious combination of CT exercises as compared to cognitive stimulation (which will serve as a stringent, active control) to modify the functional trajectories of older adults' with MCI, who are at high risk for dementia. The primary objective of the U01 phase was to design and pilot-test an adaptive, randomized clinical trial (RCT) of cognitive training (CT) combinations aimed to enhance performance of instrumental activities of daily living (IADL) among persons with mild cognitive impairment (MCI). In the R01 phase, the objective is to identify the best combination of CT exercises to delay dementia onset among persons with MCI. The longitudinal endpoint goal is reducing incident dementia. The primary aim of the study is to determine which CT combination has the best probability to delay dementia by producing the largest IADL improvements. The study further aims to explore neuroimaging and novel blood-based biomarkers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
55 to 89 years of age
Montreal Cognitive Assessment Score of 18-27 inclusive
History of some change in cognitive function relative to established baseline and either 1) a CDR of 0.5; or 2) CDR of 0 and a clinical diagnosis of mild cognitive impairment (MCI) based on a multidisciplinary evaluation that included standardized neuropsychological testing
If reports use of medications typically prescribed for dementia such as Namenda, Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon, Razadyne, Galantamine, or Reminyl, dose has been stable for at least 30 days
Disqualifiers
Currently enrolled in another randomized clinical trial, treatment trial, or another research study that assesses cognition
Dementia diagnosis
Clinical Dementia Rating Scale of 1 or greater
History of large vessel stroke with significant residual motor or cognitive impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Training
BehavioralParticipants will be completing a total of 40 computerized sessions.
Computerized Cognitive Stimulation
BehavioralParticipants will be completing a total of 40 computerized cognitive stimulation sessions.
Treatment groups
1,305 Participants
are divided into 5 treatment groupsGroup A: CTaExperimental treatment 1 intervention
Group B: CTabExperimental treatment 1 intervention
Group C: CTacExperimental treatment 1 intervention
Group D: CTabcExperimental treatment 1 intervention
Group E: Computerized Cognitive StimulationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dementia incidence
Clinical diagnosis of dementia
Time frame
At follow-up visit between 6 months to 2 yearsSecondary outcomes
1
Useful Field of View Test performance overall score
Useful Field of View test (UFOV) score across three subtests measured in milliseconds (ms). Lower scores are better.
Time frame
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months2
Graduated continuous performance test score
The metrics of performance are target accuracy (in percent correct) and the variability of responses (standard deviation of response times to target images). Higher scores are better.
Time frame
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months3
Examiner Executive Function Set shifting, Anti-Saccades, and Flanker performance composite score
The proprietary software calculates an overall executive function composite score using item response theory. Higher scores are better
Time frame
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months4
Timed IADL performance score
A composite z score is calculated that reflects the overall time and accuracy of performance on the Timed IADL subtests per standard, published procedures (SPSS syntax of scoring method can be provided). Lower scores are better.
Time frame
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 monthsOther outcomes
1
blood based biomarker Neurofilament light (Nfl)
Effect sizes of between group differences will be calculated using linear contrasts.
Time frame
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months2
blood based biomarker Total tau
Effect sizes of between group differences will be calculated using linear contrast
Time frame
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months3
blood based biomarker hydroxsphingomyelins SM (OH) C22:1, SM (OH) C22:2, SM (OH) C24:1
Effect sizes of between group differences will be calculated using linear contrasts.
Time frame
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months4
blood based biomarker brain derived neurotropic factor (BDNF)
Effect sizes of between group differences will be calculated using linear contrasts.
Time frame
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
University of Florida
Collaborator
University of Minnesota
Collaborator
National Institute on Aging (NIA)
Collaborator
Clemson University
Collaborator
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov