Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
7600 participants
INTERVENTIONAL
2019-02-19
2026-01-31
Brief Summary
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Detailed Description
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The primary objective in the R56 phase was to establish the feasibility of the proposed field trial including meeting participant enrollment goals. The feasibility of the field trial was established by accruing 1000 enrolled participants. The secondary objective in the R56 phase was to ascertain participants' willingness to enroll in a longitudinal clinical trial and to subsequently complete a multispecialty clinical diagnostic evaluation, psychometric testing, MRI, PET scan, and genetic testing. Participants' willingness to allow access to medicare records was also determined.
The trial is being expanded in the R01 phase with the goal of enrolling 7600 participants.
The primary goal is to ascertain the effectiveness of cognitive speed of processing training (SPT) to reduce the incidence of Mild Cognitive Impairment (MCI) or dementia.
Design and Outcomes: A randomized clinical trial among 7600 adults 65 years of age and older will be completed in order to test the effectiveness of computerized cognitive speed of processing training (SPT) to reduce incidence of MCI or dementia.
Participants will be screened with an inclusion/exclusion questionnaire and those potentially eligible will complete brief memory screening, depression screening, and other questionnaires. Those eligible will be randomized to one of two conditions of brain games and will complete at least two in-person, supervised training sessions. Additional exercises will be completed at-home over the next 3 to 5 months followed by booster sessions 1- and 2-years later.
Participants are asked to initially complete 25 sessions of training and will be asked complete an additional 10 sessions of booster training 1- and 2- years later. Participants are instructed to complete 2-3 sessions of training per week until 25 sessions are completed. At 1- year and again at 2-years, participants will be instructed to complete an additional 10 sessions of training.
Sample Size and Population: Adults 65 years of age and older (N=7600) will be randomly assigned to SPT (n=3800) or the active comparator condition (n=3800).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Computerized Cognitive Training
Participants will complete computerized cognitive training.
Cognitive Training
Participants will be completing a total of 45 computerized sessions.
Computerized Cognitive Stimulation
Participants will complete cognitively-stimulating computer activities.
Computerized Cognitive Stimulation
Participants will be completing a total of 45 computerized cognitive stimulation sessions.
Interventions
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Cognitive Training
Participants will be completing a total of 45 computerized sessions.
Computerized Cognitive Stimulation
Participants will be completing a total of 45 computerized cognitive stimulation sessions.
Eligibility Criteria
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Inclusion Criteria
* Have ability to speak and understand English or Spanish
* Report adequate sensorimotor capacity to perform the computer exercises
* Report adequate visual capacity to read from a computer screen at a typical viewing distance
* Show adequate auditory capacity to understand conversational speech
* Show adequate motor capacity to touch a computer screen or control a computer mouse.
* Have no evidence of Mild Cognitive Impairment (MCI) or dementia, as assessed by the Montreal Cognitive Assessment score \>=26.
* Have adequate mental health (no self-reported diagnoses of mental illness that would interfere with ability to comply with study procedures or benefit from intervention)
* Wiling to complete all study activities
* Ability to understand study procedures and comply with them for the length of the study
Exclusion Criteria
* Previous participation in a cognitive training study
* Self-reported vision, hearing, or motor difficulties that would interfere with the ability to complete the study interventions
* Self-reported diagnosis of mild cognitive impairment, dementia, stroke, traumatic brain injury, brain tumor, or a neurological disorder that affects cognition or would interfere with the ability to benefit from the study intervention (e.g., Parkinson disease, multiple sclerosis), or any other unstable medical conditions that is predisposing to imminent cognitive or functional decline (e.g., congestive heart failure, chronic obstructive pulmonary disorder dependent on oxygen, or undergoing chemotherapy or radiation).
* Self-reported use of medications typically prescribed for dementia such as: Namenda, Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon, Razadyne, Galantamine, Reminyl, aducanumab, Aduhlem.
* Completion of 10 or more hours of a computerized cognitive training program in the last 5 years such as: Lumosity, Posit Science Brain Fitness, InSight, or Brain HQ, Lace, CogMed, CogniFit, Happy Neuron, Elevate, or Dakim
* Severe depressive symptoms (Geriatric Depression Scale score \>=5)
65 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of South Florida
OTHER
Responsible Party
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Jennifer L. O'Brien
Associate Professor
Locations
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University of Florida
Gainesville, Florida, United States
University of Florida
Jacksonville, Florida, United States
University of North Florida
Jacksonville, Florida, United States
The Roskamp Institute
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Duke Health
Durham, North Carolina, United States
Clemson University Institute for Engaged Aging
Seneca, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Nicholson JS, Hudak EM, Phillips CB, Chanti-Ketterl M, O'Brien JL, Ross LA, Lister JJ, Burke JR, Potter G, Plassman BL, Woods AJ, Krischer J, Edwards JD. The Preventing Alzheimer's with Cognitive Training (PACT) randomized clinical trial. Contemp Clin Trials. 2022 Dec;123:106978. doi: 10.1016/j.cct.2022.106978. Epub 2022 Oct 28.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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