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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
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years of data collection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years of data collection
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.
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
416 Previous Clinical Trials
181,365 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
1,704 Previous Clinical Trials
28,025,657 Total Patients Enrolled
4 Trials studying Age-related Cognitive Decline
2,505 Patients Enrolled for Age-related Cognitive Decline
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can read from a computer screen at a normal distance.I can use a computer mouse or touch a screen.You do not have any mental health conditions that would make it hard for you to follow the study instructions or benefit from the treatment.I understand and can follow the study's procedures.I have vision, hearing, or motor issues that could affect my participation in the study.I can speak and understand English or Spanish.You are already participating in another research study that involves testing cognitive abilities.I can use a computer mouse or touch a screen.I have a condition like mild cognitive impairment or dementia that affects my thinking.I am taking medication for dementia.I am 65 years old or older.I can use a computer for exercises without help.I am experiencing severe depression.I can use a computer for exercises without help.I am 65 years old or older.I can speak and understand English or Spanish.I can hear and understand normal conversation.I have completed over 10 hours of a recognized brain training program in the last 5 years.I can read from a computer screen at a normal distance.You have already taken part in a study that involved cognitive training in the past.I can hear and understand normal conversation.
Research Study Groups:
This trial has the following groups:- Group 1: Computerized Cognitive Training
- Group 2: Computerized Cognitive Stimulation
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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