Preventing Alzheimer's With Cognitive Training
PACT
Cognitive Training to Reduce Incidence of Cognitive Impairment in Older Adults
3 other identifiers
interventional
7,600
1 country
7
Brief Summary
Dementia is the most expensive medical condition in the US and increases in prevalence with age. More than 5 million Americans have Alzheimer's disease, the most common form of dementia. Mild cognitive impairment is a transitional stage between normal cognitive aging and Alzheimer's disease or another type of dementia, and is indicative of higher risk for dementia. In addition to the obvious health and quality-of-life ramifications of dementia, there are high direct (e.g., subsidizing residential care needs) and indirect (e.g., lost productivity of family caregivers) economic costs. Implementing interventions to prevent MCI and dementia among older adults is of critical importance to health and maintained quality-of-life for millions of Americans. Recent data analyses from the Advanced Cognitive Training in Vital Elderly study (ACTIVE) indicate that a specific cognitive intervention, speed of processing training (SPT), significantly delays the incidence of cognitive impairment across 10 years. The primary contribution of the proposed research will be the determination of whether this cognitive training technique successfully delays the onset of clinically defined MCI or dementia across three years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2019
Longer than P75 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedStudy Start
First participant enrolled
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedSeptember 26, 2024
September 1, 2024
7 years
February 14, 2019
September 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of mild cognitive impairment or dementia
clinical diagnosis of mild cognitive impairment or dementia
Three years
Study Arms (2)
Computerized Cognitive Training
EXPERIMENTALParticipants will complete computerized cognitive training.
Computerized Cognitive Stimulation
ACTIVE COMPARATORParticipants will complete cognitively-stimulating computer activities.
Interventions
Participants will be completing a total of 45 computerized sessions.
Participants will be completing a total of 45 computerized cognitive stimulation sessions.
Eligibility Criteria
You may qualify if:
- Be age 65 or older at time of consent
- 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
You may not qualify if:
- Currently enrolled in another randomized clinical trial, treatment trial, or another research study that assesses cognition
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- National Institute on Aging (NIA)collaborator
Study Sites (7)
University of Florida
Gainesville, Florida, 32611, United States
University of Florida
Jacksonville, Florida, 32209, United States
University of North Florida
Jacksonville, Florida, 32224, United States
The Roskamp Institute
Sarasota, Florida, 34243, United States
University of South Florida
Tampa, Florida, 33620, United States
Duke Health
Durham, North Carolina, 27705, United States
Clemson University Institute for Engaged Aging
Seneca, South Carolina, 29672, United States
Related Publications (1)
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.
PMID: 36341846DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 14, 2019
First Posted
February 20, 2019
Study Start
February 19, 2019
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
September 26, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share