Computerized Memory Training for Mild Cognitive Impairment

(COMET Trial)

Overseen By Nicole Nguyen, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Investigational drugs

Disqualifiers: Alzheimer's, Parkinson's, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve memory function in people with Mild Cognitive Impairment (MCI) using a specialized computerized training program designed to enhance brain activity. The treatment, called Neuroplasticity-based Computerized Cognitive Remediation, includes 45 hours of brain exercises that focus on boosting memory through neuroplasticity, the brain's ability to change and adapt. The study seeks participants who have noticed memory issues but do not have Alzheimer's or other major neurological diseases. Participants should also have a study partner who can frequently join them in the trial process. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new methods for improving memory function.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this computerized memory training is safe for individuals with mild cognitive impairment?

Research has shown that neuroplasticity-based computerized cognitive remediation (nCCR) is generally safe. Early studies found that patients with conditions like depression in older adults and memory issues after chemotherapy tolerated this treatment well. Most participants did not experience serious side effects, indicating its safety. The treatment aims to improve memory and thinking skills through computer-based exercises that enhance the brain's adaptability and learning ability. While the studies are encouraging, individual experiences can differ. Always consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Neuroplasticity-based Computerized Cognitive Remediation for mild cognitive impairment because it taps into the brain's ability to reorganize and form new connections, known as neuroplasticity. Unlike traditional treatments such as medications or cognitive therapy, this approach uses engaging, computerized exercises to directly stimulate and enhance brain function. This method not only makes the treatment more interactive and potentially enjoyable for patients but also aims to strengthen cognitive processes more effectively by targeting the underlying mechanisms of memory loss.

What evidence suggests that Neuroplasticity-based Computerized Cognitive Remediation might be an effective treatment for Mild Cognitive Impairment?

Research shows that a computer-based program called neuroplasticity-based computerized cognitive remediation (nCCR) may help improve thinking skills. In earlier studies, nCCR successfully boosted memory and thinking abilities in people with mild cognitive impairment (MCI). Evidence also suggests that digital therapies like nCCR can enhance mood and mental skills, which is important for those facing cognitive challenges. This treatment uses exercises to help the brain form new connections. Early findings indicate that nCCR can improve memory, offering hope for people with MCI. ^{1 2 3 4 6}

Who Is on the Research Team?

Alexander C Conley, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 55-85 with Mild Cognitive Impairment (MCI), who have memory concerns but not severe dementia or Alzheimer's. Participants must be in good health, not pregnant, and fluent in English. They need a study partner available to assist during the study.

Inclusion Criteria

Have a subjective memory concern as reported by participant, study partner or clinician

Be between 55 and 85 years of age (inclusive)

Clinical Dementia Rating Global score of 0.5

Exclusion Criteria

Residence in a skilled nursing facility

Participants whom the Principal Investigator deems to be otherwise ineligible.

Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 45 hours of Neuroplasticity-based Computerized Cognitive Remediation (nCCR) to improve memory function

6 weeks

Multiple visits (frequency not specified)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neuroplasticity-based Computerized Cognitive Remediation

Trial Overview The trial tests a computer program designed to improve memory by using exercises that stimulate brain plasticity. It aims to see if regular use of this cognitive training can enhance memory function in those with MCI.

How Is the Trial Designed?

Group I: Neuroplasticity-based Computerized Cognitive Remediation Experimental Treatment 1 Intervention

Participants will receive a 45-hour of Neuroplasticity-based Computerized Cognitive Remediation

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05332522

Computerized Memory Enhancing Treatment in MCI The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to improve memory function in patients with Mild Cognitive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3387346/

Neuroplasticity-Based Computerized Cognitive Remediation ... This performance data can be used to improve an intervention's efficacy and efficiency by allowing researchers to identify and maximize key ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2950386825000231

Neural effects of a cognitive remediation intervention for ... In previous trials, digital therapeutics targeting CCD have shown preliminary efficacy in enhancing both cognitive functions and mood in LLD, ...

4. nature.com nature.com/articles/ncomms5579

Neuroplasticity-based computerized cognitive remediation ... nCCR-GD is equally as effective at reducing depressive symptoms as escitalopram but does so in 4 weeks instead of 12. In addition, nCCR-GD ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04230863

Neuroplasticity-Based Cognitive Remediation for ... The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6720324/

Cognitive training and neuroplasticity in mild cognitive ... We will test if CCT, versus CPT, leads to improved cognitive functioning, transfers to functional ability and tasks of everyday life.