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Cognitive Training for Alzheimer's Disease (PACT Trial)

Phase 3
Recruiting
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be age 65 or older at time of consent
Have ability to speak and understand English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years of data collection
Awards & highlights
No Placebo-Only Group
Pivotal Trial

PACT Trial Summary

This trial will test if a cognitive training technique can help delay the onset of mild cognitive impairment or dementia.

Who is the study for?
This trial is for individuals aged 65 or older with no signs of Mild Cognitive Impairment (MCI) or dementia, as indicated by a Montreal Cognitive Assessment score >=26. Participants must be able to perform computer exercises and have good mental health without severe depression. They should not be on dementia medications nor have completed similar cognitive training recently.Check my eligibility
What is being tested?
The study tests whether cognitive training, specifically speed of processing training (SPT), can delay the onset of MCI or dementia over three years. It involves computerized cognitive stimulation exercises designed to improve brain function in older adults.See study design
What are the potential side effects?
Since this trial involves non-invasive cognitive training exercises, there are typically no physical side effects associated with participation. However, participants may experience fatigue or frustration.

PACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
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I can speak and understand English or Spanish.
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I can hear and understand normal conversation.
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I can use a computer mouse or touch a screen.
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I am 65 years old or older.
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I can speak and understand English or Spanish.
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I can use a computer for exercises without help.
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I can read from a computer screen at a normal distance.
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I can hear and understand normal conversation.
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I can use a computer mouse or touch a screen.
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I understand and can follow the study's procedures.

PACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years of data collection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years of data collection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of mild cognitive impairment or dementia
Secondary outcome measures
Adherence, which will be quantified as percent of participants who completed 20 or more sessions of assigned exercises.
Other outcome measures
Demographics of the sample including race, ethnicity, and education levels.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

PACT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Computerized Cognitive TrainingExperimental Treatment1 Intervention
Participants will complete computerized cognitive training.
Group II: Computerized Cognitive StimulationActive Control1 Intervention
Participants will complete cognitively-stimulating computer activities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Training
2008
Completed Phase 3
~4100

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor
400 Previous Clinical Trials
177,519 Total Patients Enrolled
2 Trials studying Age-related Cognitive Decline
1,573 Patients Enrolled for Age-related Cognitive Decline
National Institute on Aging (NIA)NIH
1,647 Previous Clinical Trials
27,996,094 Total Patients Enrolled
4 Trials studying Age-related Cognitive Decline
2,505 Patients Enrolled for Age-related Cognitive Decline

Media Library

Cognitive Training Clinical Trial Eligibility Overview. Trial Name: NCT03848312 — Phase 3
Age-related Cognitive Decline Research Study Groups: Computerized Cognitive Training, Computerized Cognitive Stimulation
Age-related Cognitive Decline Clinical Trial 2023: Cognitive Training Highlights & Side Effects. Trial Name: NCT03848312 — Phase 3
Cognitive Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03848312 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project limited to only a few US states, or are there plans to expand it?

"Currently, there are 7 operational clinical trial sites. These locations are in Tucson, Gainesville and Jacksonville as well as 4 other cities. If you are considering participating in this study, it might be most convenient for you to select a location nearest you to limit travel requirements."

Answered by AI

How many people will be able to participate in this research project?

"To run this experiment, 7600 individuals that fit the pre-determined inclusion criteria are required. Patients have the opportunity to participate at Banner Alzheimer's Institute Tucson in Tucson or University of Florida in Gainesville."

Answered by AI

Are individuals still being recruited for this trial?

"From what is detailed on clinicaltrials.gov, it seems that this study is still looking for participants. The original posting was on February 19th, 2019 with the most recent edit being from March 24th, 2022."

Answered by AI

Does the FDA recognize Cognitive Training as an accepted medical treatment?

"There is some evidence to support the efficacy of Cognitive Training, as this is a Phase 3 trial. Furthermore, because there have been multiple rounds of data supporting safety, our team at Power has estimated the safety to be a 3 on a scale from 1 to 3."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
65+
What site did they apply to?
Banner Alzheimer's Institute Phoenix
Duke Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Duke Health: < 48 hours
~2106 spots leftby Jan 2026