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Preventing Alzheimer's With Cognitive Training (PACT)

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ClinicalTrials.gov Identifier: NCT03848312
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : November 22, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Jerri D. Edwards, University of South Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Age-related Cognitive Decline Alzheimer's Disease and Related Dementias Behavioral: Cognitive Training Behavioral: Computerized Cognitive Stimulation Phase 3

Detailed Description:

Preventing Alzheimer's Disease with Cognitive Training: The PACT Trial

The primary objective in the R56 phase was to establish the feasibility of the proposed field trial including meeting participant enrollment goals. The feasibility of the field trial was established by accruing 1000 enrolled participants. The secondary objective in the R56 phase was to ascertain participants' willingness to enroll in a longitudinal clinical trial and to subsequently complete a multispecialty clinical diagnostic evaluation, psychometric testing, MRI, PET scan, and genetic testing. Participants' willingness to allow access to medicare records was also determined.

The trial is being expanded in the R01 phase with the goal of enrolling 7600 participants.

The primary goal is to ascertain the effectiveness of cognitive speed of processing training (SPT) to reduce the incidence of Mild Cognitive Impairment (MCI) or dementia.

Design and Outcomes: A randomized clinical trial among 7600 adults 65 years of age and older will be completed in order to test the effectiveness of computerized cognitive speed of processing training (SPT) to reduce incidence of MCI or dementia.

Participants will be screened with an inclusion/exclusion questionnaire and those potentially eligible will complete brief memory screening, depression screening, and other questionnaires. Those eligible will be randomized to one of two conditions of brain games and will complete at least two in-person, supervised training sessions. Additional exercises will be completed at-home over the next 3 to 5 months followed by booster sessions 1- and 2-years later.

Participants are asked to initially complete 25 sessions of training and will be asked complete an additional 10 sessions of booster training 1- and 2- years later. Participants are instructed to complete 2-3 sessions of training per week until 25 sessions are completed. At 1- year and again at 2-years, participants will be instructed to complete an additional 10 sessions of training.

Sample Size and Population: Adults 65 years of age and older (N=7600) will be randomly assigned to SPT (n=3800) or the active comparator condition (n=3800).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cognitive Training to Reduce Incidence of Cognitive Impairment in Older Adults
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : January 31, 2026
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Computerized Cognitive Training
Participants will complete computerized cognitive training.
 Behavioral: Cognitive Training
Participants will be completing a total of 45 computerized sessions.
Active Comparator: Computerized Cognitive Stimulation
Participants will complete cognitively-stimulating computer activities.
 Behavioral: Computerized Cognitive Stimulation
Participants will be completing a total of 45 computerized cognitive stimulation sessions.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of mild cognitive impairment or dementia [ Time Frame: Three years ]
    clinical diagnosis of mild cognitive impairment or dementia


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848312


Contacts
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Contact: Jerri Edwards, PhD 813.974.8572 usftampapact@gmail.com
Contact: Elizabeth Hudak, PhD 813.974.8572 usftampapact@gmail.com

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Andrew O'Shea    352-294-8314    PACTUF@phhp.ufl.edu   
Principal Investigator: Adam J Woods, PhD         
University of North Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Heather Burk    904-620-4263    PACTJax@unf.edu   
Principal Investigator: Jody Nicholson, PhD         
University of South Florida Recruiting
Tampa, Florida, United States, 33620
Contact: Cognitive Aging Lab    813-974-8572    usftampapact@gmail.com   
Principal Investigator: Jerri Edwards, PhD         
Sub-Investigator: Jennifer Lister, PhD         
Sub-Investigator: Elizabeth Hudak, PhD         
Sub-Investigator: Jennifer O'Brien, PhD         
Sub-Investigator: Amanda Smith, MD         
Principal Investigator: Aryn Harrison-Bush, PhD         
United States, North Carolina
Duke Health Recruiting
Durham, North Carolina, United States, 27705
Contact: Marianne Chanti-Ketterl, PhD    919-668-3154    PACTStudy@duke.edu   
Principal Investigator: Brenda Plassman, PhD         
United States, South Carolina
Clemson University Institute for Engaged Aging Recruiting
Seneca, South Carolina, United States, 29672
Contact: Christine B Phillips, PhD    864-916-6220    PACT@clemson.edu   
Contact: Kimberly Scoles    864-916-6220    PACT@clemson.edu   
Principal Investigator: Lesley A Ross, PhD         
Sponsors and Collaborators
University of South Florida
National Institute on Aging (NIA)
  Study Documents (Full-Text)

Documents provided by Jerri D. Edwards, University of South Florida:
Statistical Analysis Plan  [PDF] November 4, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jerri D. Edwards, Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT03848312    
Other Study ID Numbers: WIRB® Protocol #20182630
1R56AG058234-01A1 ( U.S. NIH Grant/Contract )
1R01AG070349-01 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders