Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
Public ClinicalTrials.gov record NCT03001557. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of the Efficacy and Safety of Lemborexant in Subjects With Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will be conducted to determine the dose response of lemborexant (LEM) on the change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters, and circadian-rhythm related parameters. Following the eligibility screening period, eligible participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks. After a 2-week follow-up period, eligible participants may enter an open-label extension period for up to 30 months or until the program discontinuation.
Study identification
- NCT ID
- NCT03001557
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Interventions
- Lemborexant 2.5 mg Drug
- Lemborexant 5 mg Drug
- Lemborexant 10 mg Drug
- Lemborexant 15 mg Drug
- Lemborexant-matched placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 60 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 20, 2016 (Actual)
- Primary completion
- Jul 26, 2018 (Actual)
- Completion
- Apr 17, 2020 (Actual)
- Last update posted
- May 17, 2021
2016 – 2020
United States locations
- U.S. sites
- 37
- U.S. states
- 11
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Facility #1 | Little Rock | Arkansas | 72205 | — |
| Facility #1 | Rogers | Arkansas | 72758 | — |
| Facility #1 | Costa Mesa | California | 92626 | — |
| Facility #1 | Fullerton | California | 92835 | — |
| Facility #1 | Glendale | California | 91206 | — |
| Facility #1 | Irvine | California | 92614 | — |
| Facility #1 | Irvine | California | 92618 | — |
| Facility #1 | La Jolla | California | 92037-0949 | — |
| Facility #1 | San Diego | California | 92103 | — |
| Facility #1 | Santa Monica | California | 90404 | — |
| Facility #1 | Bradenton | Florida | 34205 | — |
| Facility #1 | Brandon | Florida | 33511 | — |
| Facility #1 | Brooksville | Florida | 34601 | — |
| Facility #1 | Hallandale | Florida | 33009 | — |
| Facility #1 | Miami | Florida | 33137 | — |
| Facility #1 | Miami | Florida | 33165 | — |
| Facility #1 | Miami Lakes | Florida | 33014 | — |
| Facility #1 | Miami Springs | Florida | 33016 | — |
| Facility #1 | Orlando | Florida | 32806 | — |
| Facility #2 | Orlando | Florida | 32806 | — |
| Facility #1 | Sunrise | Florida | 33351 | — |
| Facility #2 | Tampa | Florida | 33613 | — |
| Facility #1 | Atlanta | Georgia | 30331 | — |
| Facility #1 | Columbus | Georgia | 31909 | — |
| Facility #1 | Macon | Georgia | 31201 | — |
| Facility #1 | Wichita | Kansas | 67207 | — |
| Facility #1 | Belmont | Massachusetts | 02478 | — |
| Nevada Senior Services (NSS) Adult Day Care Center | Henderson | Nevada | — | — |
| Facility #1 | Las Vegas | Nevada | 89104 | — |
| Facility #1 | Toms River | New Jersey | 08755 | — |
| Facility #2 | Toms River | New Jersey | 08755 | — |
| Facility #1 | Charlotte | North Carolina | 28270 | — |
| Facility #2 | Durham | North Carolina | 27705 | — |
| Facility #1 | Raleigh | North Carolina | 27612 | — |
| Facility #1 | Norristown | Pennsylvania | 19401 | — |
| Facility #1 | Willow Grove | Pennsylvania | 19090 | — |
| Facility #1 | Columbia | South Carolina | 29203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03001557, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 17, 2021 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03001557 live on ClinicalTrials.gov.