The Preventing Alzheimer's with Cognitive Training (PACT) randomized clinical trial.
Jody S Nicholson, Elizabeth M Hudak, Christine B Phillips...
https://pubmed.ncbi.nlm.nih.gov/36341846Actively Recruiting
Phase 3
Age: 65Years +
All Genders
Healthy Volunteers
ID03848312
Cognitive Training to Reduce Incidence of Cognitive Impairment in Older Adults
Led by University of South Florida · Updated on 2024-09-26
7600
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of South Florida
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Dementia, particularly Alzheimer's disease, affects millions of older adults and is associated with significant health, quality-of-life, and economic challenges. Mild cognitive impairment (MCI) is an early stage that indicates higher risk for dementia. This trial aims to determine if computerized cognitive speed of processing training (SPT) can delay the onset of MCI or dementia over a three-year period. The study builds on previous findings that suggest cognitive training may reduce cognitive decline in older adults. The trial is a randomized clinical study enrolling 7,600 adults aged 65 and older. Participants will be randomly assigned to either computerized cognitive speed of processing training or an active comparator involving computerized cognitive stimulation. Each participant will complete 45 training sessions, including supervised in-person sessions and additional exercises done at home over 3 to 5 months. Booster training sessions will be given at one and two years after the initial training. Participants will undergo screening assessments including memory and depression evaluations, followed by psychometric testing, clinical diagnostic evaluations, MRI and PET scans, and genetic testing. Researchers will monitor adherence to training through supervised and at-home sessions. The main outcome measured is the incidence of mild cognitive impairment or dementia over three years. The study includes ongoing assessments to evaluate cognitive status and safety throughout the trial period.
CONDITIONS
Brief Title
Preventing Alzheimer's With Cognitive Training
Who Can Participate
Age: 65Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Be age 65 or older at time of consent
- Ability to speak and understand English or Spanish
- Adequate sensorimotor ability to perform computer exercises
- Adequate vision to read a computer screen at typical distance
- Adequate hearing to understand conversational speech
- Adequate motor skills to touch a computer screen or use a mouse
- No evidence of mild cognitive impairment or dementia (MoCA score >=26)
- Adequate mental health without interfering diagnoses
- Willingness to complete all study activities
- Ability to understand and comply with study procedures for study duration
You will not qualify if you...
- Currently enrolled in another randomized clinical or cognitive treatment trial
- Previous participation in a cognitive training study
- Vision, hearing, or motor difficulties interfering with study participation
- Diagnosis of mild cognitive impairment, dementia, stroke, brain injury, brain tumor, or neurological disorders affecting cognition
- Unstable medical conditions predisposing to cognitive or functional decline
- Use of medications typically prescribed for dementia
- Completion of 10 or more hours of computerized cognitive training in last 5 years
- Severe depressive symptoms (Geriatric Depression Scale score >=5)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 to 5 months with booster sessions at 1 and 2 years
Participants complete computerized cognitive training or cognitively-stimulating computer activities through a series of supervised and at-home sessions aimed to reduce the incidence of mild cognitive impairment or dementia.
At least 2 in-person supervised training sessions, followed by at-home sessions 2-3 times per week until 25 sessions are completed, plus booster sessions with 10 additional training sessions at 1 year and 2 years
Trial Site Locations
Total: 7 locations
1
University of Florida
Gainesville, Florida, United States, 32611
Active, Not Recruiting
2
University of Florida
Jacksonville, Florida, United States, 32209
Active, Not Recruiting
3
University of North Florida
Jacksonville, Florida, United States, 32224
Terminated
4
The Roskamp Institute
Sarasota, Florida, United States, 34243
Actively Recruiting
5
University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
6
Duke Health
Durham, North Carolina, United States, 27705
Actively Recruiting
7
Clemson University Institute for Engaged Aging
Seneca, South Carolina, United States, 29672
Actively Recruiting
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Research Team
J
Jennifer L O'Brien, PhD
J
Jennifer Lister, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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