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

NCT04171323 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1305

Last updated 2025-12-11

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Jerri Edwards, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171323 on ClinicalTrials.gov