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/36341846/Actively Recruiting
Led by University of South Florida · Updated on 2024-09-26
7600
Participants Needed
7
Research Sites
N/A
Total Duration
Dementia, particularly Alzheimers 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
Preventing Alzheimer's With Cognitive Training
J
Jennifer L O'Brien, PhD
J
Jennifer Lister, PhD
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University of South Florida
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Cognitive Training (45 sessions) | Cognitive Stimulation (45 sessions) | Lifestyle Prevention (guideline-based) |
|---|---|---|---|
| What it is | A 45‑session computerized cognitive training program delivered over approximately 2.5 years to improve cognitive resilience | A 45‑session computerized cognitive stimulation program delivered on the same schedule as training | Lifestyle-based prevention strategies—including cognitive training, social activity, physical activity, healthy diet and health management—are recommended to reduce dementia risk in cognitively healthy older adults |
| Role in the trial | Investigational arm assigned computerized cognitive training | Active comparator assigned computerized cognitive stimulation | Not randomized; reflects usual lifestyle-based preventive advice |
| Purpose or strategy | To test whether structured computerized cognitive training can delay onset of MCI or dementia | To provide an active engagement control condition for cognitive stimulation comparison | Represents current recommended approaches for dementia risk reduction through lifestyle behaviors |
| How it is given | Participants complete 45 computerized sessions delivered over approximatly 2.5 years | Participants complete 45 computerized cognitive stimulation sessions over the same schedule | Implemented through routine lifestyle counseling or self‑management; not structured as study sessions |
| Evidence status | Effect on delaying mild cognitive impairment or dementia is under investigation; trial results not yet available | Effect compared with training is under investigation; evidence pending trial results | Lifestyle interventions including cognitive activity are supported by global evidence for reducing dementia risk |
| Limitations | Unable to conclude benefit on MCI or dementia until follow‑up results are available | Similar limitation applies; relative effect to training not yet known | Guideline advice based on population‑level evidence not directly comparable to structured programs tested in RCT |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Jody S Nicholson, Elizabeth M Hudak, Christine B Phillips...
https://pubmed.ncbi.nlm.nih.gov/36341846/University of South Florida
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor