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The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia
NCT04171323 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- BEHAVIORAL Cognitive Training
- BEHAVIORAL Computerized Cognitive Stimulation
Study Locations (6)
Florida
- University of Florida — Gainesville
- Active Mind Study — Tampa
South Carolina
- Clemson University — Greenville
- Clemson University — Seneca
California
- University of California San Francisco — San Francisco
Minnesota
- University of Minnesota — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,305 participants |
| Start Date | 2020-03-03 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04171323
The ClinicalTrials.gov registry entry for NCT04171323 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,305 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions — of which Cognitive Training is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04171323 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Florida, South Carolina, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04171323 about?
NCT04171323 is a clinical study titled "The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia". 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 stimulati...
What is the current status of trial NCT04171323?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,305 participants. The study started on 2020-03-03. Estimated completion is 2028-08-31.
What conditions does trial NCT04171323 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Dementia, Age-related Cognitive Decline. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04171323?
The interventions under investigation include: Cognitive Training (BEHAVIORAL), Computerized Cognitive Stimulation (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04171323?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04171323 being conducted?
This trial has 6 study locations across California, Florida, Minnesota, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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