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Preventing Alzheimer's With Cognitive Training (PACT)

Primary Purpose

Age-related Cognitive Decline, Alzheimer's Disease and Related Dementias

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Cognitive Training

Computerized Cognitive Stimulation

About this trial

This is an interventional prevention trial for Age-related Cognitive Decline

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

University of FloridaRecruiting
University of North FloridaRecruiting
University of South FloridaRecruiting
Duke HealthRecruiting
Clemson University Institute for Engaged AgingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Computerized Cognitive Training

Computerized Cognitive Stimulation

Arm Description

Participants will complete computerized cognitive training.

Participants will complete cognitively-stimulating computer activities.

Outcomes

Primary Outcome Measures

Incidence of mild cognitive impairment or dementia

clinical diagnosis of mild cognitive impairment or dementia

Secondary Outcome Measures

Full Information

NCT ID

NCT03848312

First Posted

February 14, 2019

Last Updated

November 21, 2022

Sponsor

University of South Florida

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT03848312

Brief Title

Preventing Alzheimer's With Cognitive Training

Acronym

PACT

Official Title

Cognitive Training to Reduce Incidence of Cognitive Impairment in Older Adults

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 19, 2019 (Actual)

Primary Completion Date

January 31, 2026 (Anticipated)

Study Completion Date

January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of South Florida

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Cognitive Decline, Alzheimer's Disease and Related Dementias

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

7600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Computerized Cognitive Training

Arm Type

Experimental

Arm Description

Participants will complete computerized cognitive training.

Arm Title

Computerized Cognitive Stimulation

Arm Type

Active Comparator

Arm Description

Participants will complete cognitively-stimulating computer activities.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Training

Intervention Description

Participants will be completing a total of 45 computerized sessions.

Intervention Type

Behavioral

Intervention Name(s)

Computerized Cognitive Stimulation

Intervention Description

Participants will be completing a total of 45 computerized cognitive stimulation sessions.

Primary Outcome Measure Information:

Title

Incidence of mild cognitive impairment or dementia

Description

clinical diagnosis of mild cognitive impairment or dementia

Time Frame

Three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jerri Edwards, PhD

Phone

813.974.8572

usftampapact@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth Hudak, PhD

Phone

813.974.8572

usftampapact@gmail.com

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew O'Shea

Phone

352-294-8314

PACTUF@phhp.ufl.edu

First Name & Middle Initial & Last Name & Degree

Adam J Woods, PhD

Facility Name

University of North Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heather Burk

Phone

904-620-4263

PACTJax@unf.edu

First Name & Middle Initial & Last Name & Degree

Jody Nicholson, PhD

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33620

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cognitive Aging Lab

Phone

813-974-8572

usftampapact@gmail.com

First Name & Middle Initial & Last Name & Degree

Jerri Edwards, PhD

First Name & Middle Initial & Last Name & Degree

Jennifer Lister, PhD

First Name & Middle Initial & Last Name & Degree

Elizabeth Hudak, PhD

First Name & Middle Initial & Last Name & Degree

Jennifer O'Brien, PhD

First Name & Middle Initial & Last Name & Degree

Amanda Smith, MD

First Name & Middle Initial & Last Name & Degree

Aryn Harrison-Bush, PhD

Facility Name

Duke Health

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marianne Chanti-Ketterl, PhD

Phone

919-668-3154

PACTStudy@duke.edu

First Name & Middle Initial & Last Name & Degree

Brenda Plassman, PhD

Facility Name

Clemson University Institute for Engaged Aging

City

Seneca

State/Province

South Carolina

ZIP/Postal Code

29672

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine B Phillips, PhD

Phone

864-916-6220

PACT@clemson.edu

First Name & Middle Initial & Last Name & Degree

Kimberly Scoles

Phone

864-916-6220

PACT@clemson.edu

First Name & Middle Initial & Last Name & Degree

Lesley A Ross, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36341846

Citation

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.

Results Reference

derived

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Preventing Alzheimer's With Cognitive Training

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