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

Affiliations

¹ Department of Psychology, University of North Florida, 1 UNF Dr, Jacksonville, FL 32224, United States. Electronic address: jody.nicholson@unf.edu.
² Department of Psychiatry & Behavioral Neurosciences, University of South Florida, 3515 E. Fletcher Ave, Tampa, FL 33613, United States.
³ Department of Psychology, Institute for Engaged Aging, Clemson University, 298 Memorial Dr, Seneca, SC 29672, United States.
⁴ Department of Psychiatry and Behavioral Sciences, Duke University, Duke University Medical Center, Box 102505, Durham, NC 27705, United States.
⁵ Department of Psychology, University of South Florida, DAV 100, 140 7th Ave South, St. Petersburg, FL 33701, United States.
⁶ Department of Communication Sciences and Disorders, University of South Florida, 4202 E. Fowler Ave, PCD1017, Tampa, FL 33620-8200, United States.
⁷ Department of Neurology, Duke University, Bryan Research Building, 311 Research Dr, Durham, NC 27710, United States.
⁸ Department of Clinical and Health Psychology, University of Florida, 1225 Center Dr, Gainesville, FL 32610-0165, United States.
⁹ Health Informatics Institute, University of South Florida, 3650 Spectrum Blvd, Tampa, FL 33612, United States.

PMID: 36341846
PMCID: PMC10312210
DOI: 10.1016/j.cct.2022.106978

Randomized Controlled Trial

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

Jody S Nicholson et al. Contemp Clin Trials. 2022 Dec.

. 2022 Dec:123:106978.

doi: 10.1016/j.cct.2022.106978. Epub 2022 Oct 28.

Affiliations

¹ Department of Psychology, University of North Florida, 1 UNF Dr, Jacksonville, FL 32224, United States. Electronic address: jody.nicholson@unf.edu.
² Department of Psychiatry & Behavioral Neurosciences, University of South Florida, 3515 E. Fletcher Ave, Tampa, FL 33613, United States.
³ Department of Psychology, Institute for Engaged Aging, Clemson University, 298 Memorial Dr, Seneca, SC 29672, United States.
⁴ Department of Psychiatry and Behavioral Sciences, Duke University, Duke University Medical Center, Box 102505, Durham, NC 27705, United States.
⁵ Department of Psychology, University of South Florida, DAV 100, 140 7th Ave South, St. Petersburg, FL 33701, United States.
⁶ Department of Communication Sciences and Disorders, University of South Florida, 4202 E. Fowler Ave, PCD1017, Tampa, FL 33620-8200, United States.
⁷ Department of Neurology, Duke University, Bryan Research Building, 311 Research Dr, Durham, NC 27710, United States.
⁸ Department of Clinical and Health Psychology, University of Florida, 1225 Center Dr, Gainesville, FL 32610-0165, United States.
⁹ Health Informatics Institute, University of South Florida, 3650 Spectrum Blvd, Tampa, FL 33612, United States.

PMID: 36341846
PMCID: PMC10312210
DOI: 10.1016/j.cct.2022.106978

Abstract

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.govNCT03848312.

Keywords: Aging; Alzheimer's disease; Blood biomarkers; Dementia; Useful field of view training.

Published by Elsevier Inc.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Edwards worked between 1996 and 2005 as a consultant conducting related research studies for Visual Awareness, Inc., who owned the intellectual property surrounding the speed of processing training software. Posit Science now markets the newest version of the training program. Over an approximate three-month period in 2008, Dr. Edwards worked as a limited consultant to Posit Science, Inc. to analyze data and prepare a publication. Dr. Edwards worked as a consultant to Wilson, Sonsini, Goodrich & Rosati across an approximate three-month period between May–August of 2015.

References

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1. National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Committee on Preventing Dementia and Cognitive Impairment. Preventing cognitive decline and dementia: A way forward. Downey A, Stroud C, Landis S, Leshner AI, editors. Washington (DC): National Academies Press (US); 2017. - PubMed

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

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

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