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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04171323
Status
Recruiting
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Conditions

  • Age-related Cognitive Decline
  • Dementia
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
55 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Training — BEHAVIORAL
    Participants will be completing a total of 40 computerized sessions.
  • Computerized Cognitive Stimulation — BEHAVIORAL
    Participants will be completing a total of 40 computerized cognitive stimulation sessions.

Study Details

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.

Key Dates

Start date
Mar 3, 2020
Status verified
Dec 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
1,305 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CTa
    Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.
  • Experimental: CTab
    Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.
  • Experimental: CTac
    Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.
  • Experimental: CTabc
    Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.
  • Active Comparator: Computerized Cognitive Stimulation
    Participants will complete cognitively-stimulating computer activities. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

Primary Outcome Measure

Dementia incidence [ Time Frame: At follow-up visit between 6 months to 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94158
Lana Callies
[email protected]
Joel Kramer, PhD (SUB_INVESTIGATOR)
University of FloridaGainesvilleFlorida32611
Andrew O'Shea
Joseph Gullet, PhD (SUB_INVESTIGATOR)
Active Mind StudyTampaFlorida33617
Active Mind Trial Coordinator
[email protected]
813-644-9374
University of MinnesotaMinneapolisMinnesota55455-
Clemson UniversityGreenvilleSouth Carolina29607
Active Mind Trial Coordinator
[email protected]
864-916-6220
Clemson UniversitySenecaSouth Carolina29672
Lesley A Ross, PhD (SUB_INVESTIGATOR)

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By research site
University of California San Francisco· San Francisco, CAUniversity of Florida· Gainesville, FLActive Mind Study· Tampa, FLUniversity of Minnesota· Minneapolis, MNClemson University· Greenville, SCClemson University· Seneca, SC

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