Digital Therapeutics for Cognitive Decline

Overseen By David Ziegler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Under 60 years old

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3-6 weeks

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to use digital tools to boost brain function, specifically for older adults who may be experiencing cognitive decline. Participants will use MediTrain, a digital meditation app, for varying durations to assess its impact on cognitive health. An active control group will use a different app for comparison. The trial seeks participants who are 60 years or older, fluent in English, and own a smartphone or tablet.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cognitive health in older adults.

Will I have to stop taking my current medications?

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

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

Research has shown that MediTrain is generally safe for people. One study found that MediTrain improved focus in healthy young adults without causing major side effects. Another small study found it helped people with mild memory problems sleep better and feel less stressed, again with no significant negative effects reported. These results suggest MediTrain is safe to use, with no major negative effects noted so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MediTrain and Worder because they represent a fresh approach to addressing cognitive decline. Unlike conventional treatments, which often involve medications or in-person therapy, these digital therapeutics offer a non-invasive, easily accessible method through smartphone apps. MediTrain stands out with its unique meditation-based approach, which can be personalized in terms of duration and frequency, potentially offering flexibility to fit various lifestyles. Worder, while not detailed here, likely offers another innovative digital solution, adding to the excitement around digital therapeutics' potential to enhance cognitive function with convenience and adaptability.

What evidence suggests that this trial's treatments could be effective for cognitive decline?

Research shows that digital meditation apps like MediTrain, which participants in this trial will use, might enhance brain function. Studies on similar lifestyle changes, such as following the Mediterranean diet, have found they can slow mental decline by about 18%. Regularly engaging in activities that require mental focus, like meditation, could benefit brain health. While the specific effects of MediTrain are still under investigation, the basic idea is that regularly exercising the brain might help slow or improve mental decline. ^{6 7 8 9 10}

Who Is on the Research Team?

Adam Gazzaley, MD/PhD

Principal Investigator

University of California, San Francisco

David Ziegler, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MediTrain
• Worder

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.

How Is the Trial Designed?

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+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

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Mediterranean Diet, Cognitive Function, and Dementia The majority of studies showed that the MD was associated with improved cognitive function, a decreased risk of cognitive impairment or decreased risk of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2997798/

Mediterranean diet and cognitive function in older adults Recent findings​​ A high adherence to the Mediterranean diet has been associated with slower cognitive decline, with reduced risk of Mild Cognitive Impairment ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1279770725001551

The association between the MIND diet and cognitive ... Cognitive decline, a natural aspect of aging, is linked to negative outcomes like increased mortality and social isolation. The Mediterranean-DASH ...

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Examining the efficacy of the Mediterranean-DASH diet ... The review reveals consistent evidence suggesting a positive association between adherence to the MIND diet and improved cognitive performance.

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The role of the Mediterranean diet in reducing the risk ... The aggregated data showed that greater adherence to the Mediterranean diet reduced the rate of cognitive decline by approximately 18%, and ...

6. withpower.com withpower.com/trial/phase-aging-8-2024-9ce14

Digital Interventions for Mild Cognitive Impairment MediTrain is unique because it is a digital intervention specifically designed to address cognitive deficits in mild cognitive impairment (MCI) through ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7534732/

Closed-loop Digital Meditation Improves Sustained Attention ... In conclusion, we found that MediTrain led to improvement in the ability of healthy young adults to stabilize their attention from moment-to-moment across two ...

8. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06633978

Digital Interventions on Cognition, Wellbeing, Stress, and ... A pilot study of the impact of personalized digital meditation on improving sleep and reducing stress in MCI.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11467311/

Systematic review and meta-analysis of standalone digital ... We found a small-to-moderate positive pooled effect on cognition (k = 71; g = −0.51, 95%CI −0.64 to −0.37; p < 0.00001) and mental health (k = 30; g = −0.41, 95 ...

10. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-025-06223-x

Development of a (digital) mindfulness-informed intervention ... The authors found positive effects on a large array of outcomes, including perceived stress [20], awareness, self-reflection and self-acceptance ...