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← Trials/Trial dossier/NCT06093126

RecruitingPhase 4

Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial

Asset

Lemborexant

Listed sites

1

Recruiting sites

1

Enrollment

1

estimated

Study population

Frontotemporal dementia

Key I/E criterion

-

Primary endpoints

•Total sleep time•Sleep onset latency (SOL)•Wake time after sleep onset

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDLembN01
NCT IDNCT06093126

Timeline

Milestones

Study first posted2023-10-23actual
Study start2023-12-11actual
Last update posted2025-02-21actual
Primary completion2028-12-11estimated
Study completion2028-12-11estimated

Assets

Drug assets

Lemborexant

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Identified by clinician investigator to have early-onset dementia and a significant component of insomnia

Exclusion criteria

•Known sleep disorders that are contraindications for orexin antagonist therapy.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
4
Other (unclassified)
3

Behavior / neuropsychiatric

4 endpoints
Primary/protocol endpoint

Total sleep time

Time frame:Daily for 8 weeks

time to event, event

Primary/protocol endpoint

Sleep onset latency (SOL)

Time frame:Daily for 8 weeks

descriptive

Primary/protocol endpoint

Wake time after sleep onset

Time frame:Daily for 8 weeks

descriptive

Primary/protocol endpoint

Quality of sleep

Time frame:Weekly for 8 weeks

descriptive

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Number of night awakenings

Time frame:Daily for 8 weeks

event count, event

Secondary/protocol endpoint/low confidence

Presence & severity of ADRs

Time frame:Daily for 8 weeks

event count, event

Secondary/protocol endpoint/low confidence

Drop-out due to ADR

Time frame:Daily for 8 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.