TranS-C for Mild Cognitive Impairment

Overseen By Allison G Harvey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Berkeley

Disqualifiers: Active illness, Degenerative disease, Night shift, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The main empirical question to be addressed is: What types of memory support are most potent for patients who are experiencing a mild cognitive impairment (MCI) relative to non-MCI patients?

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 TranS-C for Mild Cognitive Impairment?

Research suggests that improving sleep quality can help maintain cognitive health in older adults with mild cognitive impairment (MCI). A study found that light therapy, which is part of the TranS-C treatment, improved sleep quality and cognitive performance in patients with Alzheimer's disease, indicating potential benefits for those with MCI as well. ^{1 2 3 4 5}

Is TranS-C generally safe for humans?

The available research suggests that interventions like bright light therapy and sleep hygiene, which are part of TranS-C, are generally safe for humans. These strategies have been used in studies to improve sleep quality and cognitive function without significant safety concerns. ^{2 4 6 7 8}

How is the TranS-C treatment different from other treatments for mild cognitive impairment?

TranS-C is unique because it focuses on improving sleep and circadian rhythms (the body's internal clock) through personalized strategies like bright light therapy and physical activity, which are tailored to the individual's biological clock. This approach aims to enhance sleep quality and cognitive function, unlike other treatments that may not specifically target sleep and circadian rhythms. ^{2 4 5 9 10}

Eligibility Criteria

This trial is for English-speaking individuals aged 60 or older who are experiencing memory loss and sleep issues. They must have mild cognitive impairment (MCI) with specific scores on the Montreal Cognitive Assessment, access to a computer and internet, and be able to attend weekly sessions. Those with progressive mental/physical illnesses or night shift work are excluded.

Inclusion Criteria

Have a computer to use and an internet connection

I can attend weekly sessions on the same day each week.

Fluent in English

Exclusion Criteria

You have worked overnight for more than 2 nights per week in the last 3 months.

I have an ongoing and worsening mental, physical, or neurological condition.

I am unable or unwilling to follow the study's procedures or treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive memory support interventions, including constructive and non-constructive memory supports, during treatment sessions

8 weeks

Weekly sessions

Follow-up

Participants are monitored for memory recall and application of therapy points after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Transdiagnostic sleep and circadian intervention (TranS-C)

Trial Overview The study tests a Transdiagnostic sleep and circadian intervention (TranS-C) aimed at improving memory in patients with mild cognitive impairment compared to those without MCI. It explores which memory support methods are most effective.

Participant Groups

Group I: Constructive memory support Active Control 1 Intervention

Participants will watch videos of a sleep expert delivering treatment components from the Transdiagnostic Sleep and Circadian Intervention (TranS-C). After each video, a team member will deliver constructive memory supports.

Group II: Non-constructive memory support Active Control 1 Intervention

Participants will watch videos of a sleep expert delivering treatment components from the Transdiagnostic Sleep and Circadian Intervention (TranS-C). After each video, a team member will deliver non-constructive memory supports.

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+

Findings from Research

Patients with mild cognitive impairment (MCI) and amnestic MCI (aMCI) exhibit significant alterations in sleep architecture, including reduced total sleep time, lower sleep efficiency, and increased wake time after sleep onset, which may contribute to cognitive decline.

Non-amnestic MCI (naMCI) showed fewer sleep disturbances, with significant differences only in wake time after sleep onset, suggesting that sleep quality may play a role in the progression of cognitive impairment in MCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of macroscopic sleep structure in patients with mild cognitive impairment: a systematic review. Liang, Y., Liu, W., Wang, M.[2023]

In patients with mild to moderate Alzheimer's disease, light therapy tailored to their individual circadian rhythms significantly improved sleep quality and cognitive performance, indicating its potential as a beneficial intervention.

The study demonstrated that light therapy can induce a phase shift in circadian rhythms, which is linked to better sleep and cognitive outcomes, highlighting the importance of circadian regulation in managing Alzheimer's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Circadian Phase Tailored Light Therapy on Sleep, Mood, and Cognition in Alzheimer's Disease: Preliminary Findings in a Pivotal Study. Cremascoli, R., Sparasci, D., Giusti, G., et al.[2022]

Patients with mild cognitive impairment (MCI) exhibit significant sleep disturbances, as confirmed by both polysomnographic (PSG) recordings and self-reported sleep measures, indicating that sleep quality is impaired in this population.

The study suggests that subjective sleep complaints in MCI patients do not accurately predict objective sleep fragmentation, highlighting the potential for using sleep disturbances as a marker for preclinical Alzheimer's disease and guiding future therapeutic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polysomnographic and subjective sleep markers of mild cognitive impairment. Hita-Yañez, E., Atienza, M., Cantero, JL.[2022]

A 24-week randomized controlled trial will test a personalized chronotherapy intervention, including bright light therapy and tailored physical activity, to improve sleep quality in 96 older adults with mild cognitive impairment (MCI).

Improving sleep quality through this intervention may help maintain cognitive health and reduce the risk of dementia in older adults, addressing a common issue among those with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buying time: a proof-of-concept randomized controlled trial to improve sleep quality and cognitive function among older adults with mild cognitive impairment. Falck, RS., Davis, JC., Best, JR., et al.[2018]

This scoping review analyzed 188 studies involving 17,139 participants with Mild Cognitive Impairment (MCI) and early dementia, highlighting that sleep abnormalities are prevalent in these populations and may contribute to cognitive decline.

Despite advances in technology, sleep was primarily measured using validated questionnaires rather than more objective methods like polysomnography, indicating a need for standardized sleep outcome measures to improve the assessment of sleep interventions in dementia research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The past, present, and future of sleep measurement in mild cognitive impairment and early dementia-towards a core outcome set: a scoping review. Blackman, J., Morrison, HD., Lloyd, K., et al.[2022]

This study will assess the feasibility and acceptability of using a higher dose (25 mg) of melatonin in 40 older adults with mild cognitive impairment (MCI) over 12 weeks, focusing on its potential to reduce brain oxidative stress and improve sleep disturbances.

The trial is designed as a randomized, double-blind, placebo-controlled study, which will provide valuable insights into the effects of melatonin on cognitive function and may inform future research aimed at preventing dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study. Menczel Schrire, Z., Phillips, CL., Duffy, SL., et al.[2021]

Individuals with mild cognitive impairment (MCI) show significant disruptions in circadian rhythms, such as changes in rest-activity patterns and hormone levels, which are linked to cognitive deficits.

Restoring regular circadian rhythms may offer a promising intervention to prevent or slow the progression of neurodegenerative diseases and improve cognitive function in MCI patients, highlighting the need for further longitudinal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian Rhythm Changes in Healthy Aging and Mild Cognitive Impairment. Keihani, A., Mayeli, A., Ferrarelli, F.[2023]

The article proposes new standards for identifying and naming sleep/wake cycle disturbances in Alzheimer's disease (AD) to improve research and treatment development, highlighting the significant impact these disturbances have on patients and caregivers.

The FDA has recognized the need for a comprehensive diagnostic system for behavioral problems in dementia, indicating that better-defined criteria could facilitate pharmacological research and lead to effective treatments for sleep disturbances in AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of diagnostic criteria for defining sleep disturbance in Alzheimer's disease. Yesavage, JA., Friedman, L., Ancoli-Israel, S., et al.[2017]

This study aims to improve our understanding of sleep and circadian rhythm disorders in individuals with Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI-AD) by using advanced sleep measurement technology over a 2-month period, which includes both home-based EEG recordings and wrist-worn actigraphy.

By focusing on micro-architectural sleep measures and compensatory responses to poor sleep, the research seeks to uncover potential targets for interventions that could improve cognitive performance and quality of life in AD patients, while also aiding in early diagnosis of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote evaluation of sleep to enhance understanding of early dementia due to Alzheimer's Disease (RESTED-AD): an observational cohort study protocol. Blackman, J., Morrison, HD., Gabb, V., et al.[2023]

Circadian sleep disorders are prevalent among older adults, particularly those with Alzheimer's disease (AD) and mild cognitive impairment (MCI), and can worsen symptoms and disease progression.

Preliminary evidence suggests that light therapy, which utilizes both regular light-dark patterns and 40 Hz flickering light, may improve sleep and cognitive function in individuals with AD and MCI by promoting circadian phase shifting and gamma-wave entrainment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Light Exposures in Humans: A Case for Dual Entrainment in the Treatment of Alzheimer's Disease. Figueiro, MG., Leggett, S.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Characteristics of macroscopic sleep structure in patients with mild cognitive impairment: a systematic review. [2023]

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

Effects of Circadian Phase Tailored Light Therapy on Sleep, Mood, and Cognition in Alzheimer's Disease: Preliminary Findings in a Pivotal Study. [2022]

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

Polysomnographic and subjective sleep markers of mild cognitive impairment. [2022]

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

Buying time: a proof-of-concept randomized controlled trial to improve sleep quality and cognitive function among older adults with mild cognitive impairment. [2018]

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

The past, present, and future of sleep measurement in mild cognitive impairment and early dementia-towards a core outcome set: a scoping review. [2022]

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

Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Circadian Rhythm Changes in Healthy Aging and Mild Cognitive Impairment. [2023]

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

Development of diagnostic criteria for defining sleep disturbance in Alzheimer's disease. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Remote evaluation of sleep to enhance understanding of early dementia due to Alzheimer's Disease (RESTED-AD): an observational cohort study protocol. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Light Exposures in Humans: A Case for Dual Entrainment in the Treatment of Alzheimer's Disease. [2023]