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NCT03777722 · ClinicalTrials.gov registry record · NA
Light and the Effect on Metabolic Syndrome and Alzheimer's Disease
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 61
- Enrollment target
NCT03777722 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 61 participants.
The verdict
NCT03777722, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Tailored Lighting Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2025-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03777722
The ClinicalTrials.gov registry entry for NCT03777722 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tailored Lighting Intervention is the first listed.
NCT03777722 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03777722 about?
NCT03777722 is a clinical study titled "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 d...
What is the current status of trial NCT03777722?
This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2018-11-19. Estimated completion is 2025-05-31.
What interventions are being tested in trial NCT03777722?
The interventions under investigation include: Tailored Lighting Intervention (DEVICE).
Who is sponsoring clinical trial NCT03777722?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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