Digital Therapeutics for Cognitive Decline

Recruiting in Palo Alto (17 mi)

Overseen by David Ziegler, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Disqualifiers: Under 60 years old

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goals of the proposed research are to first determine the minimal and/or optimal dose of a digital intervention required for cognitive enhancement, and then to examine the impact of several potential moderators of treatment effects (i.e., cognitive decline, AD polygenic hazard score, cardiovascular risk, and race/ethnicity). This knowledge gained from his high-impact study with transform the field of cognitive interventions, paving the way for a precision medicine model for cognitive enhancing interventions that improve quality of life for older adults and individuals with cognitive deficits at risk of developing dementia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment MediTrain, Worder, Caplyta, ITI-007, ITI-722 for cognitive decline?

Digital therapeutics, which include tools like mobile apps and virtual reality, have shown promise in improving memory and cognitive function in conditions like Alzheimer's disease. These technologies can help manage symptoms and enhance patient care, suggesting potential benefits for cognitive decline. ^{1 2 3 4 5}

What makes the treatment MediTrain, Worder unique for cognitive decline?

MediTrain, Worder is unique because it incorporates digital therapeutics, which use software and technology like apps and virtual reality to support cognitive function and manage symptoms, offering a non-drug approach to treatment. ^{1 2 5 6 7}

Research Team

Adam Gazzaley, MD/PhD

Principal Investigator

University of California, San Francisco

David Ziegler, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults over the age of 60 who speak English and own a smartphone or tablet. It's aimed at those experiencing cognitive impairment, aging-related memory issues, or mild cognitive decline.

Inclusion Criteria

Owning a smartphone or tablet

English language fluency

I am 60 years old or older.

Exclusion Criteria

I am younger than 60 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with a digital meditation app for varying durations (15 or 30 minutes per day) over 3 to 6 weeks, or use an active control application for 6 weeks

3-6 weeks

Immediate Follow-up

Participants are assessed immediately after the treatment phase to evaluate cognitive and emotional outcomes

1 week

6-Month Follow-up

Participants are monitored for long-term effects on cognitive and emotional measures

6 months

Treatment Details

Interventions

• MediTrain (Behavioral Intervention)
• Worder (Behavioral Intervention)

Trial Overview The study tests two digital programs: MediTrain and Worder. They're designed to enhance attention and wellbeing in older adults. The research will determine how much treatment is needed for cognitive improvement and explore factors that might influence its effectiveness.

Participant Groups

Group I: MediTrain 30m/day for 6wks Experimental Treatment 1 Intervention

Participants will engage with a digital meditation app for the time listed above.

Group II: MediTrain 30m/day for 3wks Experimental Treatment 1 Intervention

Participants will engage with a digital meditation app for the time listed above.

Group III: MediTrain 15m/day for 6wks Experimental Treatment 1 Intervention

Participants will engage with a digital meditation app for the time listed above.

Group IV: MediTrain 15m/day for 3wks Experimental Treatment 1 Intervention

Participants will engage with a digital meditation app for the time listed above.

Group V: Active Control Group Active Control 1 Intervention

An active control application will be used for this arm. The total training experience here will be for 6 weeks (5 days/week), with each training session lasting \~30 minutes (not including self-paced breaks). Here an app that is matched in terms of expectancy of benefits compared to our training groups will be determined by questioning 100 naïve individuals to predict their expected improvement on each cognitive domain across a multitude of possible applications.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

Digital therapeutics (Dtx) are emerging as a promising adjunctive therapy for Alzheimer's disease (AD), utilizing technology like mobile apps and virtual reality to improve cognitive function and manage symptoms.

Dtx offers non-invasive, evidence-based interventions that can enhance patient care and health outcomes, addressing the urgent need for effective treatments in a disease that currently has no cure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Intervention For The Management Of Alzheimer's Disease. Manchanda, N., Aggarwal, A., Setya, S., et al.[2023]

Age-related cognitive impairment (ARCI) is linked to underlying brain pathology, highlighting the need for early detection and personalized interventions to improve health span.

The Intelligent Technology Therapy Assistant (ITA) concept, exemplified by platforms like the Guttman Neuro Personal Trainer® and the Barcelona Brain Health Initiative app, aims to enhance access to clinical expertise while maintaining a personal connection between patients and clinicians, potentially improving the effectiveness of cognitive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aging in the Digital Age: Using Technology to Increase the Reach of the Clinician Expert and Close the Gap Between Health Span and Life Span. Gomes-Osman, J., Solana-Sánchéz, J., Rogers, E., et al.[2023]

In a study involving 345 dyads of persons with mild cognitive impairment (PwMCI) and their caregivers, the SMART4MD tablet application was found to be more costly and less effective for PwMCI compared to standard care, with a mean QALY change of -0.004.

For informal caregivers, SMART4MD was less costly and showed a slight improvement in quality of life (QALY change of 0.003), suggesting that while the intervention may not benefit PwMCI significantly, it could provide some advantages for their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short Term Economic Evaluation of the Digital Platform "Support, Monitoring and Reminder Technology for Mild Dementia" (SMART4MD) for People with Mild Cognitive Impairment and their Informal Caregivers. Ghani, Z., Saha, S., Jarl, J., et al.[2022]

There is currently no pharmacological treatment to stop the progression of Alzheimer's disease and dementia, making Mild Cognitive Impairment (MCI) a critical area for research and intervention.

Recent studies have focused on using information and communication technologies, including sensors, personal devices, and robots, to assess and assist patients with MCI, but there is still significant potential for improvement in these technological solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Technological Solutions for Assessment, Treatment, and Assistance in Mild Cognitive Impairment. Mancioppi, G., Fiorini, L., Timpano Sportiello, M., et al.[2020]

Wearable devices and passive sensors can collect continuous and objective data on daily activities, potentially identifying cognitive changes before dementia symptoms appear.

These digital technologies could enhance clinical trials for Alzheimer's by improving participant recruitment and retention, as well as providing new endpoints for measuring treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital technologies as biomarkers, clinical outcomes assessment, and recruitment tools in Alzheimer's disease clinical trials. Gold, M., Amatniek, J., Carrillo, MC., et al.[2022]

The HERB-DH1 pivotal trial demonstrated that digital therapeutics significantly reduced 24-hour ambulatory blood pressure in patients with hypertension not on medication, with a mean reduction of 2.4 mmHg compared to standard lifestyle modifications alone.

The study involved 390 patients over 12 weeks and found no major safety issues related to the digital therapeutic program, indicating it is a safe and effective non-pharmacological treatment option for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial. Kario, K., Nomura, A., Harada, N., et al.[2021]

Digital therapeutics are innovative software-based interventions designed to prevent, manage, or treat various medical conditions, including mental health disorders and chronic diseases, and they offer flexibility to meet individual patient needs.

Despite their potential benefits, none of the currently available digital therapeutics have received FDA clearance, highlighting the need for regulatory frameworks and user-centered approaches to ensure their effective integration into healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction of digital therapeutics. Hong, JS., Wasden, C., Han, DH.[2021]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Digital Intervention For The Management Of Alzheimer's Disease. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Aging in the Digital Age: Using Technology to Increase the Reach of the Clinician Expert and Close the Gap Between Health Span and Life Span. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Short Term Economic Evaluation of the Digital Platform "Support, Monitoring and Reminder Technology for Mild Dementia" (SMART4MD) for People with Mild Cognitive Impairment and their Informal Caregivers. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Technological Solutions for Assessment, Treatment, and Assistance in Mild Cognitive Impairment. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Digital technologies as biomarkers, clinical outcomes assessment, and recruitment tools in Alzheimer's disease clinical trials. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Introduction of digital therapeutics. [2021]