Cognitive Training for Alzheimer's Disease
(PACT Trial)
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of South Florida
Must not be taking: Dementia medications
Disqualifiers: MCI, Dementia, Stroke, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
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.
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.
12345Is 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.
16789How 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.
12101112Eligibility Criteria
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.
+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.
+4 more
Trial Timeline
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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Duke HealthDurham, NC
University of FloridaJacksonville, FL
The Roskamp InstituteSarasota, FL
University of South FloridaTampa, FL
More Trial Locations
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Who Is Running the Clinical Trial?
University of South FloridaLead Sponsor
National Institute on Aging (NIA)Collaborator
References
[Computer-assisted neuropsychological training in neurological rehabilitation]. [2006]Using computer-assisted cognitive training to treat patients with cognitive disorders has proved a useful tool in neurological rehabilitation. This has been shown by positive experience in many rehabilitation clinics but also in numerous control studies investigating the efficiency of such training. Patients with attention deficits show the most pronounced improvements as the computer with its technical possibilities is an ideal training instrument because of stimulus representation and reaction time measures. In other areas, computer training has become an essential therapeutic means complementing other therapies. In a clinical environment it seems that computer training is essential because it enables attaining the necessary therapeutic density. However, training must be integrated and become part of a global therapeutic framework.
Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial. [2022]Computerized Cognitive Training (CCT) has been shown to improve cognitive function in older adults with mild cognitive impairment (MCI) or mood-related neuropsychiatric symptoms (MrNPS), but many questions remain unresolved.
Computer-based cognitive intervention for dementia: preliminary results of a randomized clinical trial. [2022]Dementia is a highly invalidating condition and, given the progressive aging of the population, one of the major issues that health systems will have to face in future years. Recently there has been an increase in the potential of diagnostic tools and pharmacological treatments for dementia; moreover, considerable interest has been expressed regarding non pharmacological interventions. However, the current evidence in support of non pharmacological treatments in patients affected by dementia still does not allow to draw definitive conclusions on what is the most effective treatment to apply, largely because of methodological difficulties and limitations of the studies so far carried out due to the complex nature of the disease. To address this need, we carried out a single blind randomized controlled study on the efficacy of computer cognitive rehabilitation in patients with mild cognitive decline. We here present preliminary data on 11 patients with diagnosis of Alzheimer's Disease (AD) and mild cognitive decline randomly assigned to treatment (a) or control (b) condition (i.e. specific vs. aspecific treatment). The specific treatment (a) consisted in a cycle of 12 individual sessions of computer exercises, while the control condition (b) consisted in sessions of semi-structured interviews with patients, conducted with the same frequency and time period as (a). Cognitive, behavioural and functional assessment was performed by an expert evaluator, blinded to the patients' group allocation. Preliminary results show a significant performance decline only in the control group at the 9-month follow-up compared to both baseline and the 3-month follow-up. Our results suggest that computer based cognitive training in patients with AD and mild cognitive decline is effective at least in delaying the continuous progression of cognitive impairment in AD.
Web-based cognitive training: patient adherence and intensity of treatment in an outpatient memory clinic. [2021]Cognitive training has been playing an increasing role in the treatment of patients with cognitive deficits. This type of intervention, namely its intensity, can be optimized by incorporating information technology-based systems.
Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]We describe the clinical impact of the RehaCom computerized cognitive training program instituted in the International Neurological Restoration Center for rehabilitation of brain injury patients. Fifty patients admitted from 2008 through 2010 were trained over 60 sessions. Attention and memory functions were assessed with a pre- and post-treatment design, using the Mini-Mental State Examination, Wechsler Memory Scale and Trail Making Test (Parts A and B). Negative effects were assessed, including mental fatigue, headache and eye irritation. The program's clinical usefulness was confirmed, with 100% of patients showing improved performance in trained functions.
Controlling for Placebo Effects in Computerized Cognitive Training Studies With Healthy Older Adults From 2016-2018: Systematic Review. [2020]Computerized cognitive training has been proposed as a potential solution to age-related cognitive decline. However, published findings from evaluation studies of cognitive training games, including metastudies and systematic reviews, provide evidence both for and against transferability from trained tasks to untrained cognitive ability. There continues to be no consensus on this issue from the scientific community. Some researchers have proposed that the number of results supporting the efficacy of cognitive training may be inflated due to placebo effects. It has been suggested that placebo effects need to be better controlled by using an active control and measuring participant expectations for improvement in outcome measures.
Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. [2022]Previous meta-analyses indicate that computerized cognitive training (CCT) is a safe and efficacious intervention for cognition in older adults. However, efficacy varies across populations and cognitive domains, and little is known about the efficacy of CCT in people with mild cognitive impairment or dementia.
The Effects of Gamification on Computerized Cognitive Training: Systematic Review and Meta-Analysis. [2020]There has been a growing interest in the application of gamification (ie, the use of game elements) to computerized cognitive training. The introduction of targeted gamification features to such tasks may increase motivation and engagement as well as improve intervention effects. However, it is possible that game elements can also have adverse effects on cognitive training (eg, be a distraction), which can outweigh their potential motivational benefits. So far, little is known about the effectiveness of such applications.
Doctor, Should I Use Computer Games to Prevent Dementia? [2020]Commercial advertising of computerized "brain games" may result in clinicians being asked whether brain games prevent dementia. To address this question, we conducted a review of computerized cognitive training (CCT) interventions in older adults with Mild Cognitive Impairment (MCI). Studies were identified using a PubMed and PSYCinfo search for review articles. Within 11 review articles we identified 15 unique studies. Nine of these studies used commercially available "brain games" as their primary CCT intervention. Nine of 12 studies that examined the effect of CCT on episodic memory performance showed significant improvements in this domain. Furthermore, four of six studies that examined mood and or anxiety showed improvements in these domains following a CCT intervention. While more than double the amount of time was spent on the training that used commercially available "brain games" versus those designed by investigators, there were no differences in outcomes. Overall, it appears that "brain games" may modestly benefit aspects of cognition and aspects of mood in patients presenting with MCI. However, there is no direct evidence from the studies presented here that "brain games"/CCT can prevent dementia. We present recommendations to consider when discussing "brain games" with persons with MCI.
Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial. [2020]Mild cognitive impairment (MCI) is common in older adults and represents a high-risk group for progression to Alzheimer's disease (AD). Medication trials in MCI have generally failed, but new discoveries with brain plasticity in ageing have led to the study of cognitive training as a potential treatment to improve cognitive abilities. Computerised cognitive training (CCT) involves computerised cognitive exercises that target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
Cognitive Training Using Fully Immersive, Enriched Environment Virtual Reality for Patients With Mild Cognitive Impairment and Mild Dementia: Feasibility and Usability Study. [2020]Cognitive training using virtual reality (VR) may result in motivational and playful training for patients with mild cognitive impairment and mild dementia. Fully immersive VR sets patients free from external interference and thus encourages patients with cognitive impairment to maintain selective attention. The enriched environment, which refers to a rich and stimulating environment, has a positive effect on cognitive function and mood.
Comparing three methods of computerised cognitive training for older adults with subclinical cognitive decline. [2018]Cognitive rehabilitation for mild cognitive impairment (MCI) and early Alzheimer's disease is readily available to the geriatric population. Initial evidence suggests that techniques incorporating motivational strategies to enhance treatment engagement may provide more benefit than computerised training alone. Seventy four adults with subclinical cognitive decline were randomly assigned to computerised cognitive training (CCT), Cognitive Vitality Training (CVT), or an Active Control Group (ACG), and underwent neuropsychological evaluations at baseline and four-month follow-up. Significant differences were found in changes in performance on the Modified Mini Mental State Examination (mMMSE) and measures of verbal learning and memory across treatment groups. Experimental groups showed greater preservation of functioning on the mMMSE than the ACG group, the CVT group performed better than the ACG group on one measure of verbal learning and both measures of verbal memory, and the CCT group performed better than the ACG group on one measure of verbal learning and one measure of verbal memory. There were no significant group differences between the CVT and CCT groups on measures of verbal learning or memory. It was concluded that computerised cognitive training may offer the most benefit when incorporated into a therapeutic milieu rather than administered alone, although both appear superior to more generic forms of cognitive stimulation.