Light and the Effect on Metabolic Syndrome and Alzheimer's Disease
This study's main hypothesis is that a delivering a tailored lighting intervention (TLI) will provide a successful means for promoting circadian entrainment and treating metabolic disease and inflammation in patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD) and Alzheimer's disease and related dementias (ADRD). As such, the proposed studies have the potential to provide important insights into the link between AD/ADRD and type 2 diabetes (T2DM) by identifying the disruption of circadian rhythms as a key component in the metabolic impairment. Preliminary data from ongoing studies demonstrates a beneficial effect of light treatment on sleep and depression. If positive results are observed, the potential also exists to transform the manner in which homes, assisted living facilities, and nursing homes are lighted by delivering a simple, practical, non-pharmacological intervention to promote entrainment, improve sleep, and reduce metabolic disease in AD and mild AD MCI patients. This randomized, placebo-controlled, crossover study involving 60 AD/ADRD patients who live in controlled environments (i.e., assisted living facilities and nursing homes), will investigate whether 8 weeks of exposure to a TLI designed to increase circadian entrainment improves sleep, mood, inflammatory markers, and metabolic control, compared to a control, circadian-inactive light.
Conditions:
🦠 Alzheimer Disease
🦠 Diabetes Mellitus, Type 2
🗓️ Study Start (Actual)
1 November 2018
🗓️ Primary Completion (Estimated)
31 October 2024
✅ Study Completion (Estimated)
30 April 2025
👥 Enrollment (Estimated)
60
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
New Brunswick, New Jersey, United States
📍
Albany, New York, United States
📍
New York, New York, United States
Description
Inclusion Criteria:
- * Diagnosis of mild to moderate Alzheimer's disease or related dementia,
- * sleep disturbance as determined by a score ≥ 5 on the PSQI
Exclusion Criteria:
- * insulin-dependent diabetes,
- * urinary incontinence
- * obstructing cataracts
- * macular degeneration
- * blindness
- * severe sleep apnea or
- * restless leg syndrome (RLS)
Ages Eligible for Study:
55 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
12 December 2018
- First Submitted that Met QC Criteria
13 December 2018
- First Posted
17 December 2018
Study Record Updates
- Last Update Submitted that Met QC Criteria
8 February 2024
- Last Update Posted
12 February 2024
- Last Verified
February 2024