The Preventing Alzheimer's with Cognitive Training (PACT) randomized clinical trial

JS Nicholson, EM Hudak, CB Phillips… - Contemporary clinical …, 2022 - Elsevier
JS Nicholson, EM Hudak, CB Phillips, M Chanti-Ketterl, JL O'Brien, LA Ross, JJ Lister…
Contemporary clinical trials, 2022Elsevier
Background To address the rising prevalence of Alzheimer's disease and related dementias,
effective interventions that can be widely disseminated are warranted. The Preventing
Alzheimer's with Cognitive Training study (PACT) investigates a commercially available
computerized cognitive training program targeting improved Useful Field of View Training
(UFOVT) performance. The primary goal is to test the effectiveness of UFOVT to reduce
incidence of clinically defined mild cognitive impairment (MCI) or dementia with a secondary …
Background
To address the rising prevalence of Alzheimer's disease and related dementias, effective interventions that can be widely disseminated are warranted. The Preventing Alzheimer's with Cognitive Training study (PACT) investigates a commercially available computerized cognitive training program targeting improved Useful Field of View Training (UFOVT) performance. The primary goal is to test the effectiveness of UFOVT to reduce incidence of clinically defined mild cognitive impairment (MCI) or dementia with a secondary objective to examine if effects are moderated by plasma β-amyloid level or apolipoprotein E e4 (APOE e4) allele status.
Methods/design
This multisite study utilizes a randomized, controlled experimental design with blinded assessors and investigators. Individuals who are 65 years of age and older are recruited from the community. Eligible participants who demonstrate intact cognitive status (Montreal Cognitive Assessment score > 25) are randomized and asked to complete 45 sessions of either a commercially available computerized-cognitive training program (UFOVT) or computerized games across 2.5 years. After three years, participants are screened for cognitive decline. For those demonstrating decline or who are part of a random subsample, a comprehensive neuropsychological assessment is completed. Those who perform below a pre-specified level are asked to complete a clinical evaluation, including an MRI, to ascertain clinical diagnosis of normal cognition, MCI, or dementia. Participants are asked to provide blood samples for analyses of Alzheimer's disease related biomarkers.
Discussion
The PACT study addresses the rapidly increasing prevalence of dementia. Computerized cognitive training may provide a non-pharmaceutical option for reducing incidence of MCI or dementia to improve public health.
Registration: The PACT study is registered at http://Clinicaltrials.gov NCT03848312
Elsevier
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