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

Trial Summary

What is the purpose of this trial?

The goal of this proposed research is to collect pilot data to test the hypothesis that treatment with a novel form of closed-loop digital meditation (MediTrain) will lead to a greater magnitude of gains in cognitive abilities in patients with mild cognitive impairment (MCI), compared to OA without cognitive impairment, and will lead to improvements in quantitative measures of sleep.

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 data supports the effectiveness of the treatment MediTrain for mild cognitive impairment?

Research on similar digital interventions, like TECH and computer-based cognitive training, shows potential benefits in improving memory and cognitive functions in older adults with mild cognitive impairment. These studies suggest that digital treatments can help maintain or enhance cognitive abilities over time. ^{1 2 3 4 5}

Is the digital intervention for mild cognitive impairment safe for humans?

The safety of a cognitive-enhancing Tai Ji Quan training intervention, delivered online for older adults with mild cognitive impairment, was examined and found to be acceptable, suggesting it is generally safe for humans. ^{6 7 8 9 10}

How is the MediTrain treatment different from other treatments 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 interactive and engaging methods, unlike traditional treatments that may not focus on digital engagement. This approach leverages technology to provide cognitive training in a way that is accessible and potentially more engaging for patients. ^{1 2 4 11 12}

Research Team

David Ziegler, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 '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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. Switzerland 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. [2020]

2. Switzerland 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. [2023]

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

Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. [2023]

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

Interactive computer-training as a therapeutic tool in Alzheimer's disease. [2006]

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

Clinical trials in mild cognitive impairment: lessons for the future. [2018]

7. New Zealand 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. [2022]

8. England 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. [2020]

9. England 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. [2022]

10. United States 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. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. [2022]

12. Switzerland 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). [2020]