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A 4-week, Open-label, Single-center Trial to Evaluate the Effectiveness of Lemborexant in Participants with Insomnia Comorbid with a Clinical Diagnosis of Mild Cognitive Impairment or Mild Dementia

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Insomnia
Date of first enrollment	22/05/2026
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	Participants will initiate LEM treatment at a dose of 5 mg at the beginning of the Treatment Phase. The dose may be adjusted at the discretion of the investigator in accordance with the approved dosage and administration described in the package insert but must not exceed 10 mg per day. LEM (5 mg or 10 mg) will be administered by the study partner orally in tablet form each night immediately before the time the participant intends to try to sleep.

Outcome(s)

Primary Outcome	The changes from baseline in TST and WASO at Week 4 of the treatment with LEM in the participants with elevated p-tau217.
Secondary Outcome	None

Key inclusion & exclusion criteria

Age minimum	>= 50age old
Age maximum	<= 90age old
Gender	Both
Include criteria	1. Has provided written informed consent, obtained from the participant and their study partner 2. Is between 50 and 90 years of age at the time of informed consent 3. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for insomnia disorder 4. Has complaints of cognitive impairment and: -Meets the diagnostic criteria or clinical symptoms for MCI due to AD or Alzheimer's-type dementia. For diagnostic criteria, Alzheimer's-type dementia is assessed using DSM-5. MCI due to AD is evaluated based on the criteria established by the National Institute on Aging and the Alzheimer's Association (NIA-AA), or alternatively, the Albert criteria -Has MMSE-J scores of 20 or more at screening (Week -1) 5. Male or female. Females must be postmenopausal (defined as amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy), with the procedure completed at least one month prior to the time of the informed consent. 6. Meets the following criteria regarding insomnia: -Has not used any insomnia medications in the past 14 days -Has an average baseline TST <6.5 hours as confirmed by the device at screening -Has an average baseline WASO >_45 minutes as confirmed by device at screening 7.Has a study partner(s) (spouse, family member, or other caregiver) that meets the following criteria. -Capable of providing consent -Not diagnosed with dementia -Able to spend time with the participant during the night and secure sufficient and regular time with the participant -Able to take responsibility for supervising medication procedures and devices -Available to be present at all trial visits -Willing to provide personal information related to their caregiving burden.
Exclude criteria	1. Has a history or current diagnosis of specific sleep disorders other than insomnia, including but not limited to circadian rhythm sleep-wake disorders, REM sleep behavior disorder, periodic limb movement disorder, restless legs syndrome, parasomnias, idiopathic hypersomnia, narcolepsy, or cataplexy. 2. Has a history of excessive daytime napping (defined as more than 2 hours a day for more than 3 days of the week based on estimates provided by the study partner, on average for the past 4 weeks) 3. Has a history of severe obstructive sleep apnea 4. Has a history of severe liver dysfunction 5. Has a history of seizures or epilepsy within 5 years prior to screening 6. Is unable to use the mattress type device appropriately (eg, those exceeding the weight limit of 138 kg; those who sometimes sleep at night on a sofa or in a location other than their own bed; those who have difficulty securing a power source near the bed; those who share their bed with spouse, children, other family members or pets; or those who are unable to mount the device appropriately on an electric reclining bed, etc.) 7. Is expected to be unable to collect sleep data using the mattress type devise during the one-week period immediately prior to Visit 2 (Week 0) or Visit 3 (Week 4), due to reasons such as staying away from home. 8. Is unable to agree to refrain from alcohol consumption during the study participation 9. Has evidence of a clinically relevant neurological disorder: delirium; frontotemporal dementia/MCI; vascular dementia/MCI; dementia/MCI due to Lewy bodies disease, Human Immunodeficiency Virus (HIV), prion disease, Parkinson's disease, Huntington's disease, traumatic brain injury, substance or medication, or any other medical condition(s) (eg, multiple sclerosis, chronic subdural hematoma, normal pressure hydrocephalus); or delusional disorder. 10. Clinically significant disease that could affect the participant's safety or interfere with the study assessments in the opinion of the investigators, including unstable psychiatry disorders 11. Geriatric Depression Scale (GDS) score >_ 10 12. Has hypersensitivity to LEM (Dayvigo tablets) or its excipients 13. Is currently using, plans to use during the potential course of the study, or has a history of using lecanemab or donanemab 14. Is deemed inappropriate for participation by the principal investigator, sub-investigator, or other qualified personnel.