Cognitive Training for Alzheimer's Disease

(PACT Trial)

Recruiting at 7 trial locations

Overseen By Jennifer Lister, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of South Florida

Must not be taking: Dementia medications

Disqualifiers: MCI, Dementia, Stroke, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 3-5 months

7600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific type of computer-based brain training can delay memory problems or dementia. Participants will either engage in computerized cognitive training (also known as cognitive therapy or brain training) or participate in stimulating computer activities. The trial seeks individuals aged 65 or older who can read from a computer screen, understand conversational speech, and currently have no memory issues. The goal is to help maintain mental sharpness and quality of life for older adults. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that computerized cognitive training (CCT) is safe and can improve brain functions in older adults. Studies have found that CCT enhances memory skills, such as remembering words and pictures. It is particularly beneficial for individuals with mild cognitive impairment (MCI), a condition that can lead to Alzheimer's disease.

Previous research indicates that CCT is well-tolerated, with most people not experiencing negative side effects. Meta-analyses confirm that CCT is safe for older adults.

Research also supports the effectiveness and safety of computerized cognitive stimulation. Both training and stimulation methods improve thinking skills in those at risk of cognitive decline.

In summary, both computerized cognitive training and stimulation are considered safe for humans. They have been tested and shown to support brain health without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the cognitive training and computerized cognitive stimulation methods for Alzheimer's disease because they offer a non-drug approach to managing the condition. Unlike traditional treatments such as cholinesterase inhibitors or memantine, which primarily target chemical imbalances in the brain, these techniques focus on enhancing cognitive abilities through mental exercises. They leverage technology to engage specific brain functions, potentially slowing cognitive decline more naturally and with fewer side effects. This innovative approach could complement existing therapies and offer patients more holistic care options.

What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?

Research has shown that computerized cognitive training (CCT), which participants in this trial may receive, can improve various types of memory, such as remembering words and pictures. One study found that this training enhances skills like planning, focusing, and short-term memory. Another study suggested that CCT might even reverse up to ten years of brain aging, making learning and remembering easier. Meanwhile, computerized cognitive stimulation, another treatment option in this trial, proves helpful, especially for individuals in the early stages of Alzheimer's disease. It has improved thinking skills in older adults, aiding in managing memory problems related to dementia. ^{2 3 6 7 8}

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.

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.

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?

Group I: Computerized Cognitive Training Experimental Treatment 1 Intervention

Participants will complete computerized cognitive training.

Group II: Computerized Cognitive Stimulation Active Control 1 Intervention

Participants will complete cognitively-stimulating computer activities.

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

A study involving 74 adults with mild cognitive impairment showed that both Cognitive Vitality Training (CVT) and Computerised Cognitive Training (CCT) were more effective than an Active Control Group in preserving cognitive function over four months, as measured by the Modified Mini Mental State Examination (mMMSE).

The results suggest that combining motivational strategies with cognitive training enhances treatment engagement and effectiveness, indicating that computerised training is more beneficial when integrated into a supportive therapeutic environment rather than used in isolation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing three methods of computerised cognitive training for older adults with subclinical cognitive decline. Gooding, AL., Choi, J., Fiszdon, JM., et al.[2018]

This study will evaluate the effectiveness of home-based computerized cognitive training (CCT) in improving cognitive abilities in 100 patients with mild cognitive impairment (MCI) over 12 weeks, with follow-up booster sessions for up to 78 weeks.

The trial aims to assess not only cognitive improvements but also changes in brain structure and function, specifically looking at hippocampal volume and the default mode network, using MRI scans, making it a comprehensive approach to understanding the impact of CCT on MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial. D'Antonio, J., Simon-Pearson, L., Goldberg, T., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based cognitive intervention for dementia: preliminary results of a randomized clinical trial. Galante, E., Venturini, G., Fiaccadori, C.[2022]

A study involving 45 patients with neurological and psychiatric conditions showed that using a web-based cognitive training system, 'COGWEB', resulted in high adherence rates, with 82.8% of participants complying with their treatment plan over 18 months.

Patients with dementia engaged in more intensive training (averaging 444.6 minutes/week), and those who attended face-to-face sessions performed even better, highlighting that combining traditional methods with technology can enhance cognitive training effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based cognitive training: patient adherence and intensity of treatment in an outpatient memory clinic. Tedim Cruz, V., Pais, J., Alves, I., et al.[2021]

Only 21% of the 19 studies reviewed measured participants' expectations for improvement, and 47% used a passive control, indicating a lack of rigorous placebo control in evaluating computerized cognitive training for older adults.

Despite the poor placebo control, 9 studies reported positive results for cognitive training efficacy, with 5 of those showing far transfer effects, which raises concerns about the validity of broad claims made by cognitive training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling for Placebo Effects in Computerized Cognitive Training Studies With Healthy Older Adults From 2016-2018: Systematic Review. Masurovsky, A.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Computer-assisted neuropsychological training in neurological rehabilitation]. Reuter, BM., Schönle, PW.[2006]

Gamification in cognitive training significantly increases motivation and engagement, with a moderate effect size (Hedges g=0.72), but does not show any measurable impact on cognitive training outcomes.

The review identified 49 studies, including 9 randomized controlled trials, highlighting that while gamified tasks are more engaging, the current research is limited and lacks well-controlled empirical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Gamification on Computerized Cognitive Training: Systematic Review and Meta-Analysis. Vermeir, JF., White, MJ., Johnson, D., et al.[2020]

Computerized cognitive training (CCT), including commercially available 'brain games', may lead to modest improvements in cognitive functions like episodic memory and mood in older adults with Mild Cognitive Impairment (MCI), based on a review of 15 studies.

Despite these improvements, there is no evidence that 'brain games' can prevent dementia, highlighting the need for caution when discussing their effectiveness with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doctor, Should I Use Computer Games to Prevent Dementia? O'Shea, DM., De Wit, L., Smith, GE.[2020]

A study involving 10 physiatrists, 6 occupational therapists, and 11 patients with mild cognitive impairment and mild dementia found that a fully immersive virtual reality (VR) cognitive training program was feasible and well-received, with high satisfaction scores from both therapists (5.75) and patients (5.64).

While the training did not show statistically significant improvements in response time or finger tapping, there was a noted decrease in response time after the session, suggesting a potential temporary increase in attention, and importantly, no participants experienced any adverse effects like motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Training Using Fully Immersive, Enriched Environment Virtual Reality for Patients With Mild Cognitive Impairment and Mild Dementia: Feasibility and Usability Study. Yun, SJ., Kang, MG., Yang, D., et al.[2020]

The RehaCom computerized cognitive training program significantly improved attention and memory functions in 50 brain injury patients after 60 training sessions, with all patients showing enhanced performance in the targeted areas.

The program was well-tolerated, with no reported negative effects such as mental fatigue, headache, or eye irritation, indicating its safety for use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. Fernández, E., Bringas, ML., Salazar, S., et al.[2022]

Computerized cognitive training (CCT) shows moderate efficacy in improving overall cognition and specific cognitive domains in older adults with mild cognitive impairment, based on a review of 17 trials.

In individuals with dementia, CCT has limited evidence of efficacy, primarily influenced by a few trials using immersive technologies like virtual reality, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Hill, NT., Mowszowski, L., Naismith, SL., et al.[2022]

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