7600 Participants Needed

Cognitive Training for Alzheimer's Disease

(PACT Trial)

Recruiting at 7 trial locations
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Overseen ByJennifer Lister, PhD
Age: 65+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial excludes participants who are using medications typically prescribed for dementia, such as Namenda, Memantine, and Donepezil. If you are taking these medications, you would not be eligible to participate.

Is cognitive training safe for humans?

Research indicates that computerized cognitive training is generally safe for older adults, including those with mild cognitive impairment or dementia. It has been used effectively in neurological rehabilitation without significant safety concerns.12345

How does the Cognitive Training treatment for Alzheimer's differ from other treatments?

Cognitive Training for Alzheimer's is unique because it uses computer-based exercises to target specific brain functions and improve cognitive abilities through neuroplasticity (the brain's ability to reorganize itself). Unlike traditional drug treatments, this approach leverages technology to create engaging and adaptive exercises that can be tailored to individual needs, potentially enhancing motivation and treatment engagement.26789

What data supports the effectiveness of the treatment Cognitive Training for Alzheimer's Disease?

Research shows that computer-based cognitive training can help improve cognitive function in older adults with mild cognitive impairment and may delay the progression of cognitive decline in Alzheimer's patients. Studies have also found that such training is beneficial in neurological rehabilitation, particularly for attention deficits.29101112

Are You a Good Fit for This Trial?

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.

Inclusion 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.
See 13 more

Exclusion Criteria

I have vision, hearing, or motor issues that could affect my participation in the study.
You are already participating in another research study that involves testing cognitive abilities.
I have a condition like mild cognitive impairment or dementia that affects my thinking.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants complete computerized cognitive training with 25 initial sessions over 3 to 5 months, followed by booster sessions at 1 and 2 years

3-5 months
2 visits (in-person), additional sessions at home

Booster Sessions

Participants complete 10 additional sessions of training at 1-year and 2-years

2 years
At-home sessions

Follow-up

Participants are monitored for incidence of mild cognitive impairment or dementia

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Training
  • Computerized Cognitive Stimulation
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

Computer-assisted cognitive training has been shown to be an effective tool in neurological rehabilitation, particularly for patients with attention deficits, as it allows for precise stimulus representation and reaction time measures.
This type of training is most beneficial when integrated into a comprehensive therapeutic framework, enhancing the overall rehabilitation process and ensuring sufficient therapeutic intensity.
[Computer-assisted neuropsychological training in neurological rehabilitation].Reuter, BM., Schönle, PW.[2006]
Home-based Computerized Cognitive Training (CCT) tailored to individual needs significantly improved cognitive functions such as memory and learning in older adults with mild cognitive impairment (MCI) and mood-related neuropsychiatric symptoms (MrNPS) over an 8-12 week period.
Participants in the CCT group not only showed enhanced cognitive performance but also reported improved mood and reduced caregiver burden compared to those in the active control group, indicating broader benefits beyond just cognitive outcomes.
Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial.Bahar-Fuchs, A., Webb, S., Bartsch, L., et al.[2022]
A single blind randomized controlled study involving 11 patients with Alzheimer's Disease showed that computer-based cognitive rehabilitation can effectively delay cognitive decline compared to a control group that received semi-structured interviews.
Preliminary results indicated that only the control group experienced a significant decline in performance at the 9-month follow-up, suggesting that the specific treatment may help maintain cognitive function in patients with mild cognitive decline.
Computer-based cognitive intervention for dementia: preliminary results of a randomized clinical trial.Galante, E., Venturini, G., Fiaccadori, C.[2022]

Citations

[Computer-assisted neuropsychological training in neurological rehabilitation]. [2006]
Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial. [2022]
Computer-based cognitive intervention for dementia: preliminary results of a randomized clinical trial. [2022]
Web-based cognitive training: patient adherence and intensity of treatment in an outpatient memory clinic. [2021]
Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]
Controlling for Placebo Effects in Computerized Cognitive Training Studies With Healthy Older Adults From 2016-2018: Systematic Review. [2020]
Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. [2022]
The Effects of Gamification on Computerized Cognitive Training: Systematic Review and Meta-Analysis. [2020]
Doctor, Should I Use Computer Games to Prevent Dementia? [2020]
Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial. [2020]
Cognitive Training Using Fully Immersive, Enriched Environment Virtual Reality for Patients With Mild Cognitive Impairment and Mild Dementia: Feasibility and Usability Study. [2020]
Comparing three methods of computerised cognitive training for older adults with subclinical cognitive decline. [2018]
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