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.
An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia: The ACTIVE MIND Trial. In the U01 phase, the primary objective 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). The longitudinal endpoint goal is delaying dementia onset. The secondary objectives of the U01 phase were: \- To pilot test a plan to recruit and enroll under-represented minorities with the goal of obtaining a sample representative of the USF population in race and ethnicity. In the current R01 phase: The primary objective is to conduct 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). The longitudinal endpoint goal is reducing dementia incidence. Design: The design is an adaptive randomized trial to identify the best combination of CT exercises to improve IADL function and thereby delay dementia onset among persons with MCI. Four arms of CT will be compared to an active control condition. Outcomes: incident dementia is the primary outcome. Secondary outcome is Everyday Function: measures include Timed Instrumental Activities of Daily Living and iFunction. A composite of performance (measured by time and accuracy) will be derived. Interventions and Duration: Four combinations of computerized cognitive training and an active control computerized stimulation will be investigated. The five arms will be equivalent in terms of frequency and duration of each session (60 min/day, two-three days/wk, 16 weeks). Sample size: The study team plans to enroll up to 1305 participants. Individuals with a clinical diagnosis of MCI will be included in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,305
Participants will be completing a total of 40 computerized sessions.
Participants will be completing a total of 40 computerized cognitive stimulation sessions.
University of California San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGActive Mind Study
Tampa, Florida, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
ACTIVE_NOT_RECRUITINGClemson University
Greenville, South Carolina, United States
RECRUITINGClemson University
Seneca, South Carolina, United States
RECRUITINGDementia incidence
Clinical diagnosis of dementia
Time frame: At follow-up visit between 6 months to 2 years
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 months
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 months
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 months
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 months
ifunction performance efficiency index
An overall score reflecting time and accuracy (i.e., efficiency index) is calculated to reflect performance across the ifunction subtests the proprietary software determines the score. Higher scores are better for efficiency index
Time frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
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