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
Study identification
- NCT ID
- NCT03001557
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Eisai Inc.
- Industry
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Interventions
- Lemborexant 10 mg Drug
- Lemborexant 15 mg Drug
- Lemborexant 2.5 mg Drug
- Lemborexant 5 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 19, 2016
- Primary completion
- Jul 25, 2018
- Completion
- Apr 16, 2020
- Last update posted
- May 16, 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 16, 2021 · Synced May 11, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03001557 live on ClinicalTrials.gov.