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RECRUITING
NCT04171323
NA

The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

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.

Official title: ACTIVE MIND: An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia

Key Details

Gender

All

Age Range

55 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

1305

Start Date

2020-03-03

Completion Date

2028-08-31

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

Cognitive Training

Participants will be completing a total of 40 computerized sessions.

BEHAVIORAL

Computerized Cognitive Stimulation

Participants will be completing a total of 40 computerized cognitive stimulation sessions.

Locations (6)

University of California San Francisco

San Francisco, California, United States

University of Florida

Gainesville, Florida, United States

Active Mind Study

Tampa, Florida, United States

University of Minnesota

Minneapolis, Minnesota, United States

Clemson University

Greenville, South Carolina, United States

Clemson University

Seneca, South Carolina, United States