Preventing Alzheimer's With Cognitive Training

Age-related Cognitive Decline Clinical Trial

— PACT  

Official title:

Cognitive Training to Reduce Incidence of Cognitive Impairment in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03848312
• Other study ID #: WIRB® Protocol #20182630
• Secondary ID: 1R56AG058234-01A
• Status: Recruiting
• Phase: Phase 3
• Start date: February 19, 2019
• Est. completion date: January 31, 2026

Study information

• Verified date: November 2022
• Source: University of South Florida
• Contact: Jerri Edwards, PhD
• Phone: 813.974.8572
• Email: usftampapact[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7600
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Cognitive Training
Participants will be completing a total of 45 computerized sessions.
• Computerized Cognitive Stimulation
Participants will be completing a total of 45 computerized cognitive stimulation sessions.

Locations

Country	Name	City	State
United States	Duke Health	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	University of North Florida	Jacksonville	Florida
United States	Clemson University Institute for Engaged Aging	Seneca	South Carolina
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of mild cognitive impairment or dementia	clinical diagnosis of mild cognitive impairment or dementia	Three years