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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
Must not have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years of data collection
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

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 hear and understand normal conversation.
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I can use a computer mouse or touch a screen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have vision, hearing, or motor issues that could affect my participation in the study.
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I have a condition like mild cognitive impairment or dementia that affects my thinking.
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I am taking medication for dementia.
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I am experiencing severe depression.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of mild cognitive impairment or dementia
Secondary study objectives
Adherence, which will be quantified as percent of participants who completed 20 or more sessions of assigned exercises.
Other study objectives
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.

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
427 Previous Clinical Trials
185,031 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
1,802 Previous Clinical Trials
28,186,381 Total Patients Enrolled
5 Trials studying Age-related Cognitive Decline
2,745 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
~1190 spots leftby Jan 2026