Preventing Alzheimer's With Cognitive Training (PACT)

September 24, 2024 updated by: Jennifer L. O'Brien, University of South Florida

Cognitive Training to Reduce Incidence of Cognitive Impairment in Older Adults

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

7600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jennifer Lister, PhD
  • Phone Number: 813-974-9712
  • Email: jlister@usf.edu

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Active, not recruiting
        • University of Florida
      • Jacksonville, Florida, United States, 32209
        • Active, not recruiting
        • University of Florida
      • Jacksonville, Florida, United States, 32224
        • Terminated
        • University of North Florida
      • Sarasota, Florida, United States, 34243
        • Recruiting
        • The Roskamp Institute
        • Principal Investigator:
          • Laila Abdullah, PhD
        • Contact:
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University Of South Florida
        • Contact:
        • Principal Investigator:
          • Jennifer L O'Brien, PhD
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Health
        • Principal Investigator:
          • Brenda Plassman, PhD
        • Contact:
    • South Carolina
      • Seneca, South Carolina, United States, 29672
        • Recruiting
        • Clemson University Institute for Engaged Aging
        • Contact:
        • Principal Investigator:
          • Lesley A Ross, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of mild cognitive impairment or dementia
Time Frame: Three years
clinical diagnosis of mild cognitive impairment or dementia
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2019

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIRB® Protocol #20182630
  • 1R56AG058234-01A1 (U.S. NIH Grant/Contract)
  • 1R01AG070349-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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