Digital Interventions for Mild Cognitive Impairment

(MediDream Trial)

Overseen By David Ziegler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants, Antianxiety

Disqualifiers: Neurological, Psychiatric, Seizures, Glaucoma, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of digital meditation called MediTrain to determine if it can improve thinking skills and sleep in people with mild cognitive impairment (MCI), which involves early memory and thinking problems. The researchers aim to discover if MediTrain significantly enhances cognitive abilities compared to those without cognitive issues. Individuals who move comfortably, have good vision and hearing, and speak English fluently, but have no serious neurological or psychiatric conditions, might be suitable for this trial. As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance cognitive health.

Will I have to stop taking my current medications?

You will need to stop taking anti-depressants and anti-anxiety medications to participate in this trial.

What prior data suggests that this digital intervention is safe for individuals with mild cognitive impairment?

Research on MediTrain, the digital meditation tool being tested, remains in the early stages, so limited safety information is available. The trial is in the "Not Applicable" phase, indicating that the treatment is new or still undergoing early research. This phase often means less safety information compared to more advanced treatments.

However, as a digital meditation program, it is likely low-risk. Meditation practices generally do not cause serious side effects. Most people may find it easy to use and may experience benefits such as reduced stress or improved focus. No negative effects have been reported specifically linked to MediTrain yet. Researchers will closely monitor any effects if participants join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

MediTrain is unique because it leverages digital interventions to address mild cognitive impairment, setting it apart from traditional medications or therapies that often focus on pharmacological approaches. Unlike standard treatments that might involve drugs with potential side effects, MediTrain uses technology to enhance cognitive function through a series of personalized, brain-training exercises. Researchers are excited about this treatment because it offers a non-invasive, customizable approach that could improve cognitive performance without the need for medication, making it a promising option for those seeking alternative or adjunctive therapies.

What evidence suggests that MediTrain might be an effective treatment for mild cognitive impairment?

Research has shown that certain activities can improve brain function in people with mild cognitive impairment (MCI). One study found that these activities led to better results on brain tests for individuals with MCI. Exercise has also been shown to enhance thinking skills in people with MCI more effectively than in those with more severe memory issues. In this trial, participants will use the digital tool MediTrain, which incorporates meditation and is believed to further enhance these improvements. By leveraging technology, MediTrain aims to boost brain health and improve sleep. ^{6 7 8 9 10}

Who Is on the Research Team?

David Ziegler, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for older adults who are experiencing mild cognitive impairment. Participants should be interested in testing digital interventions aimed at improving cognition, wellbeing, stress levels, and sleep quality.

Inclusion Criteria

Fluency in spoken English

I can walk easily on my own.

I am in good physical health.

Exclusion Criteria

Substance abuse

Color blindness

Magnetically-activated implant or device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo treatment with a novel form of closed-loop digital meditation (MediTrain) to improve cognitive abilities and sleep quality

6 months

Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at immediate and 6-month follow-up

6 months

Immediate and 6-month follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• MediTrain

Trial Overview The study is examining the effectiveness of a digital meditation program called MediTrain. It also uses wrist-worn multi-sensor watches and sleep monitors to track improvements in participants' cognitive abilities and sleep patterns.

How Is the Trial Designed?

Group I: MediTrain Experimental Treatment 3 Interventions

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

The study demonstrated that a cognitively enhanced Tai Ji Quan training intervention delivered via videoconferencing is feasible and safe for older adults with mild cognitive impairment, with a high retention rate of 94% and acceptable compliance of 76%.

Participants in the cognitively enhanced Tai Ji Quan group showed positive trends in cognitive function and dual-task performance after 16 weeks, suggesting potential benefits of this intervention for improving cognitive health in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitively enhanced online Tai Ji Quan training intervention for community-dwelling older adults with mild cognitive impairment: A feasibility trial. Li, F., Harmer, P., Fitzgerald, K., et al.[2022]

The study developed a digital neurorehabilitation platform called NeuroVRehab.PT, designed specifically for patients with mild cognitive impairment (MCI), using realistic virtual environments based on a supermarket setting.

Feedback from health professionals indicated that NeuroVRehab.PT is clinically applicable and ecologically valid, suggesting it could effectively support MCI patients in improving their instrumental activities of daily living (IADL).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photo-Realistic Interactive Virtual Environments for Neurorehabilitation in Mild Cognitive Impairment (NeuroVRehab.PT): A Participatory Design and Proof-of-Concept Study. Ferreira-Brito, F., Alves, S., Santos, O., et al.[2020]

The study demonstrated that a virtual Tai Ji Quan exercise program for older adults with mild cognitive impairment (MCI) was feasible, with a high attendance rate of 79% and low attrition of 13%.

While Tai Ji Quan did not significantly reduce the incidence of falls compared to stretching, it showed better improvements in balance and functional mobility, indicating its potential as a beneficial exercise for enhancing stability in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an Online Virtual Falls Prevention Intervention During a Public Health Pandemic for Older Adults with Mild Cognitive Impairment: A Feasibility Trial. Li, F., Harmer, P., Voit, J., et al.[2022]

The smart aging serious game (SASG) effectively assesses cognitive profiles in individuals with amnestic mild cognitive impairment (aMCI) and shows good usability even among those less familiar with technology, based on a study involving 36 aMCI and 107 healthy control subjects.

SASG demonstrated superior ability to detect hippocampal degeneration compared to traditional cognitive assessments, outperforming the Montreal cognitive assessment test (MoCA), indicating its potential as a digital biomarker for early dementia detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of a Virtual Reality Platform for the Assessment of the Memory Decline and the Hippocampal Neural Injury in Subjects with Mild Cognitive Impairment: The Validity of Smart Aging Serious Game (SASG). Cabinio, M., Rossetto, F., Isernia, S., et al.[2020]

This study will evaluate the efficacy and safety of a combined treatment of electroacupuncture and computer-based cognitive rehabilitation (EA-CCR) for mild cognitive impairment (MCI) in a randomized controlled trial involving 36 participants over 8 weeks.

The primary outcome will be measured by improvements in cognitive function using the Alzheimer's Disease Assessment Scale, with additional assessments for depression and daily living activities, aiming to provide preliminary evidence for this innovative therapy approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of electroacupuncture combined with computer-based cognitive rehabilitation on mild cognitive impairment: study protocol for a pilot randomized controlled trial. Kim, JH., Han, JY., Park, GC., et al.[2020]

Computer-based cognitive interventions (CCIs) have shown significant benefits in improving specific cognitive domains such as memory and attention in individuals with mild cognitive impairment (MCI), based on a systematic review of 24 randomized controlled trials.

While CCIs did not demonstrate significant improvements in global cognition for individuals with dementia, one study indicated that CCIs could lead to memory improvements in those with subjective cognitive decline (SCD), suggesting that early intervention may be key for cognitive preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. Zuschnegg, J., Schoberer, D., Häussl, A., et al.[2023]

Current therapeutic approaches for mild cognitive impairment (MCI), especially the amnestic subtype, are largely based on strategies used for Alzheimer's disease (AD), but existing treatments like acetylcholinesterase inhibitors and antioxidants have not met primary trial objectives for efficacy in MCI.

Future clinical trials for MCI should focus on better sample selection, optimal treatment durations, and reliable outcome measures to improve the chances of identifying effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials in mild cognitive impairment: lessons for the future. Jelic, V., Kivipelto, M., Winblad, B.[2018]

In a study involving 28 participants (9 Alzheimer's patients, 9 depressed patients, and 10 healthy controls), a novel interactive computer-based cognitive training program significantly improved task performance in Alzheimer's patients over a 4-week period, with gains sustained for 3 weeks after training.

The training was well-received by participants, suggesting that interactive media could be a promising tool for rehabilitation and therapeutic interventions in cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive computer-training as a therapeutic tool in Alzheimer's disease. Hofmann, M., Rösler, A., Schwarz, W., et al.[2006]

In a randomized pilot study involving participants with mild cognitive impairment (MCI), cognitive training led to significant improvements in verbal memory and increased activation in the left hippocampus after two months.

The results indicate that the hippocampus in individuals with MCI retains enough neuroplasticity to benefit from cognitive training, as evidenced by improvements in 5 out of 6 participants in the experimental group compared to declines in all participants in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. Rosen, AC., Sugiura, L., Kramer, JH., et al.[2022]

A pilot study involving 47 participants with mild cognitive impairment showed that intensive, computer-based cognitive training improved neuropsychological assessment scores by 0.36 standard deviations, although this was not statistically significant compared to the control group.

The study suggests that while the cognitive training may have specific benefits for verbal learning and memory, further research with larger sample sizes is needed to confirm these effects and explore their potential domain-specific impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Barnes, DE., Yaffe, K., Belfor, N., et al.[2022]

The 'Tablet Enhancement of Cognition and Health' (TECH) intervention showed high feasibility and satisfaction among older adults with and without mild cognitive impairment (MCI), with 28 participants with MCI and 10 with pre-MCI reporting positive experiences.

Participants with MCI demonstrated significant improvements in memory recall and cognitive assessments, suggesting that TECH may help preserve cognitive function over time, although further research is needed to confirm its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Daily Practice of Puzzle-Game Apps on Cognition in Two Groups of Older Adults: A Pre-Post Experimental Study. Givon Schaham, N., Buckman, Z., Rand, D.[2023]

The EXERT trial successfully recruited 296 older adults with mild cognitive impairment (MCI) over 18 months, using a variety of strategies, with mass mailings being the most effective method, accounting for 52% of participants.

Targeted infographic postcards and brochures significantly boosted recruitment rates, demonstrating that tailored communication can effectively engage older adults in nonpharmacological intervention trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial. Shadyab, AH., LaCroix, AZ., Feldman, HH., et al.[2023]

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