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Preventing Alzheimer's Disease With Cognitive Training (PACT)

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ClinicalTrials.gov Identifier: NCT03848312
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Michigan State University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of South Florida

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 Behavioral: Cognitive Training Behavioral: Computerized Cognitive Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Alzheimer's Disease With Cognitive Training: The PACT Trial
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of participants enrolled [ Time Frame: 1 year of data collection ]
    The primary outcome measure will be the number of participants enrolled in this pilot trial by one year after start of data collection. The goal is at least 1200 participants successfully enrolled after 1 year of data collection, demonstrating the feasibility of a larger trial.


Secondary Outcome Measures :
  1. Adherence, which will be quantified as percent of participants who completed 20 or more sessions of assigned exercises. [ Time Frame: 1 year of data collection ]
    The percentage of participant's adherent to complete at least 20 sessions of assigned exercises. The goal is for at least 75% of those randomized to be adherent, demonstrating feasibility of a larger trial.


Other Outcome Measures:
  1. Demographics of the sample including race, ethnicity, and education levels. [ Time Frame: 1 year of data collection ]
    This outcome is descriptive in nature. The diversity of the enrolled sample will be assessed by quantifying the racial, ethnic, and educational composition of the enrolled study sample. The goal is to approximate characteristics of the US older adult population by obtaining a sample that includes 85% Caucasians, 8.5% African Americans and 3.5% Asian Americans; across whom 7% will be of Hispanic ethnicity. The goal is for <=85% of the sample to have education levels of high school or more and >=15% of the sample with education levels less than high school.

  2. Proportion of enrolled participants who are willing to participate in a longitudinal trial [ Time Frame: 1 year of data collection ]
    The proportion of enrolled participants who are willing to further participate in a subsequent longitudinal trial will be quantified. This is assessed by one yes/no question. The proportion of participants who answer yes will be quantified. The goal is for at least 80% of the enrolled participants to indicate yes that they are willing to participate in a follow-up study.

  3. Percentage of participants who are willing to complete planned study measures. [ Time Frame: 1 year of data collection ]
    The willingness of participants to complete assessments in a subsequent trial including: clinical diagnostic evaluation, psychometric testing, MRI, PET scan, and genetic testing is assessed. Their willingness to allow access to medicare records will also be determined. This is assessed through a questionnaire with yes/no answers across six items. The percentage who endorse yes to these items will be measured. The goal is for at least 80% of the participants to endorse at least 4 of the questions as yes.



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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
  • 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 USF Cognitive Aging Lab 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, or Reminyl.
  • 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, or Dakim
  • Severe depressive symptoms (Geriatric Depression Scale score >=5)

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: Alisa Houseknecht, PhD 813.974.8572 usftampapact@gmail.com

Locations
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United States, Florida
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: Ross Andel, PhD         
Sub-Investigator: Ming Ji, PhD         
Sub-Investigator: Jennifer Lister, PhD         
Sub-Investigator: Elizabeth Hudak, PhD         
Sub-Investigator: Jennifer O'Brien, PhD         
United States, Michigan
Michigan State University Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Baraa Abu-Dalu    616-234-0952    msupact@gmail.com   
Contact: Kelsey Magolan    616-234-0952    msupact@gmail.com   
Principal Investigator: Dave Morgan, PhD         
Sponsors and Collaborators
University of South Florida
Michigan State University
National Institute on Aging (NIA)

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03848312     History of Changes
Other Study ID Numbers: WIRB® Protocol #20182630
1R56AG058234-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: February 2019
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