Light Therapy for Mild Cognitive Impairment
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must not be taking: Psychotropics
Disqualifiers: Brain disease, Organ failure, Hypertension, Diabetes, others
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?To investigate the impact of a long-term light treatment intervention on sleep physiology and memory in mild cognitively impaired and mild Alzheimer's disease patients living at home. The goal is also to measure the impact of the lighting intervention on caregivers' sleep, cognition, depression, and quality of life.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have had recent changes in psychotropic medications (within 14 days), you may not be eligible to participate.
How is light therapy different from other treatments for mild cognitive impairment?
Light therapy is unique because it uses exposure to bright light to potentially improve cognitive function, unlike other treatments that often focus on cognitive exercises or psychosocial interventions. This approach is non-invasive and does not involve medication, making it a novel option for those with mild cognitive impairment.
12345Eligibility Criteria
This trial is for people living at home with mild cognitive impairment or early Alzheimer's, who have sleep issues and a caregiver willing to assist. They should score 17-24 on the MoCA test and 0.5-9.0 on the CDR-SOB scale.Inclusion Criteria
I have trouble sleeping, confirmed by tests.
You are interested in volunteering for the study.
I have mild memory loss or mild Alzheimer's with specific test scores.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a long-term light treatment intervention to improve sleep and cognition
37 weeks
Visits at baseline and the end of weeks 9, 17, 25, and 37
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests how a special lighting setup in participants' homes might affect their sleep quality and memory over time. It also looks at any changes in caregivers' sleep, cognition, depression, and life satisfaction.
2Treatment groups
Active Control
Placebo Group
Group I: Active Lighting interventionActive Control1 Intervention
The active lighting intervention will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. Combining spectrum and light level, the intervention will allow us to: (1) use a light source that will stimulate the circadian system and (2) provide the participants with options as to how the light treatment will be delivered
Group II: Control Lighting InterventionPlacebo Group1 Intervention
The control lighting intervention will consist of low levels of a warm light source designed not to impact the circadian system.
Lighting Intervention is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Light Therapy for:
- Mild Cognitive Impairment
- Alzheimer's Disease
- Sleep Disturbances
- Depression
🇪🇺 Approved in European Union as Phototherapy for:
- Dementia
- Alzheimer's Disease
- Sleep Disturbances
- Behavioral and Psychological Symptoms of Dementia (BPSD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiTroy, NY
Icahn School of Medicine at Mount SinaiAlbany, NY
Icahn School of Medicine at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
National Institute on Aging (NIA)Collaborator
Rutgers UniversityCollaborator
References
The Efficacy of Cognitive Intervention Programs for Mild Cognitive Impairment: A Systematic Review. [2019]Mild cognitive impairment (MCI) describes a transitional state in progression from normal aging to dementia, especially Alzheimer's disease (AD). Currently, there is no effective pharmacological treatment that offers a long-term beneficial effect to delay the progression to dementia. There is growing evidence that supports an important role of non-pharmacological cognitive interventions. Therefore, it is warranted to clarify the distinct forms of cognitive interventions and their effects based on previous clinical trials. We aimed to provide a review of clinical trials of non-pharmacological cognitive interventions for MCI and to address the characteristics of the study patients, cognitive intervention programs and short-term / long-term benefits of the interventions. A total of 32 articles were identified according to the inclusion criteria. The results showed positive effects for both objective and subjective outcome variables, and these effects persisted from 1 month up to 5 years. Although many of the positive effects were related to improvement in trained tasks, alterations in neuroimaging and the transfer effects shown by some studies are encouraging. Future research in this area requires a larger sample size with a wider spectrum of MCI, more instructive outcome measures and a longer follow up duration.
Home/community-based interventions to improve function in persons with mild cognitive impairment/early dementia. [2022]Persons with mild cognitive impairment/early dementia have a possible 20-year trajectory of disability and dependence with little information on the effectiveness of interventions to improve function. This review investigates the literature of home/community-based interventions for physical and executive function in persons with mild cognitive impairment/early dementia. A 2007-2020 systematic literature search was conducted through PubMed, CINAHL Plus with Full Text and PsycINFO. Of the 1749 articles retrieved, 18 eligible studies were identified and consisted of three types of interventions: cognitive training-only (n = 7), multicomponent (n = 9), and physical activity-only (n = 2). Results showed that the interventions impacting function in persons with cognitive impairment incorporated a visual/written element, technology-based training, caregiver support, and modified duration/increased frequency of interventions. In studies improving function, participants simulated Instrumental Activities of Daily Living. They addressed cognitive function using both objective and subjective cognitive measures. We found gaps in the literature in incorporating race/ethnicity and appropriate socioeconomic status measures.
Nurse-Led Computerized Cognitive Training for Mild Cognitive Impairment: A Preliminary Study. [2021]This preliminary study aimed to compare the outcomes of an occupational therapist-led and a nurse-led computerized cognitive training (CCT) for mild cognitive impairment (MCI) in older adults.
Nonpharmacological therapies for behavioral and cognitive symptoms of mild cognitive impairment. [2016]Evaluate research on nonpharmacological treatments for symptoms of mild cognitive impairment (MCI).
Art therapy is associated with sustained improvement in cognitive function in the elderly with mild neurocognitive disorder: findings from a pilot randomized controlled trial for art therapy and music reminiscence activity versus usual care. [2019]Mild cognitive impairment (MCI) is a phase in cognitive decline when it is still possible to intervene to reverse the decline. Cognitive stimulation delivered through psychosocial interventions provides both psychological intervention and social stimulation to improve cognition. A pilot open-label parallel-arms randomized controlled trial was undertaken to examine the effects of art therapy (AT) and music reminiscence activity (MRA) compared to the control, on the primary outcome of neurocognitive domain assessments in elderly people with MCI.