Alzheimer's Disease, Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, sleep and memory
Brief summary
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.
Detailed description
The current application proposes to investigate the impact of a long-term light treatment intervention on sleep physiology and sleep-dependent cognitive processes in mild cognitive impairment (MCI) and mild Alzheimer's disease (AD) patients. The premise is that older adults, especially those with cognitive impairment, are often in continuous dim light, which leads to circadian misalignment. Circadian misalignment impacts the close relationship between homeostatic and circadian processes, which can reduce memory-related sleep features. The hypothesis is that a lighting intervention technology (LIT), designed to promote circadian entrainment, will improve sleep by aligning the two sleep processes (circadian and homeostatic) and, thus improve cognition. In addition to improving patients' lives, LIT has the potential to reduce the overnight burden on caregivers. Thus, an exploratory goal is to also measure the impact of LIT on caregivers' sleep, cognition, depression, and quality of life.
Interventions
DEVICELighting Intervention
Lighting Intervention consisting of a cool or warm light source.
Sponsors
Icahn School of Medicine at Mount Sinai
Rutgers University
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
In a single-arm, randomized, placebo-controlled (non-active comparison lighting intervention), between-subjects study, we will investigate the effect of long-term exposure (6 months) to a lighting intervention, which is designed to promote circadian entrainment.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for MCI/Mild AD Participant: * Subject has diagnosis of amnestic mild cognitive impairment (MCI) or mild Alzheimer's disease (AD), as defined by a Montreal Cognitive Assessment (MoCA) score between 17 and 24 and those who fall between 0.5-4.0 and 4.5-9.0 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) instrument * Subject has sleep disturbance indicated by a score \>5 on the Pittsburgh Sleep Quality Index and sleep efficiency below 80% as indicated via actigraphy * Subject resides in his/her home, independent living, or assisted living facilities with a caregiver.
Exclusion criteria
for MCI/Mild AD Participant: * Subject diagnosed with another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis) * Subject resides in a skilled nursing facility or long-term care * Subject has had recent changes in psychotropics (14 days) * Subject has major organ failure (e.g., kidney failure) * Subject has uncontrolled generalized disorders such as hypertension or diabetes * Subject has obstructing cataracts, macular degeneration, and/or blindness * Subject has undergone cataract surgery and received an intraocular lens coated with ultraviolet- and blue-blocking filters (400-440/440-500 nm) * Subject diagnosed with severe sleep apnea; using the Sleep Apnea scale of the Sleep Disorders Questionnaire (SA-SDQ) the study will use a score of 29 as a cutoff for men and a cutoff of 26 for women * Subject diagnosed with restless leg syndrome (RLS); using the International Restless Legs Scale (IRLS), the study will use a cutoff of ≥11 as a positive screen for RLS * Subject has a history of severe photosensitivity dermatitis, severe progressive retinal disease (e.g., macular degeneration), or a permanently dilated pupil (e.g., after certain types of cataract surgery) For caregivers, we will accept those who: * Live with the patients * Are not diagnosed with dementia (MOCA between 25 and 30 and CDR=0) * Understand English * Are willing to help with the study * No other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) | Will be administered at baseline and the end of weeks 9, 17, 25 and 37 | Change in cognition of the MCI participant will be assessed utilizing the Alzheimer's Disease Assessment Scale-Cognitive to capture subtler changes in cognitive performance. The ADAS-Cog is the most widely used general cognitive measure in clinical trials of Alzheimer's disease. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality in the MCI Participant using the Pittsburgh Sleep Quality Index (PSQI) | Will be administered at baseline and the end of weeks 9, 17, 25 and 37 | Change in sleep quality of the MCI participant will be assessed utilizing the Pittsburgh Sleep Quality Index (PSQI). The PSQI is composed of 19 items that generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). The sum of the seven component scores yields a single global score. A global score \>5 is considered to indicate sleep disturbances. A lower score indicates improvement in sleep quality. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMariana Figueiro, PhD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed