None listed
Conditions
Interventions
On Visit 2 patients will initiate a transition period with single-blind placebo for a total of two weeks. After that, on Visit 4, patients will begin the double-blind treatment period which will last
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: V1: 1)Between 50 to 90 years 2)Meet the criteria for Alzheimer’s disease based on NIA-AA or DSM-5 3)Have a Mini Mental State Examination (MMSE) score ≥ 12 and ≤ 26 4)Have a DSM-5 diagnosis of insomnia 5)Stay overnight at a sleep lab and stay in bed for at least 8 hours for PSG testing 6)Have a regular bedtime between 8pm and 1am and maintain it 7)Wear an activity/sleep watch day and night 8)Sign informed consent (subject or legal representative) 9)Be able to speak, read, and understand informed consent; be able to respond verbally to questions, follow instructions, and complete study assessments; be able to adhere to dose and visits 10)Have a trial partner who: signs their own consent; resides with the subject overnight and has a close relationship with him; accompanies him to trial visits and stays overnight for the 3 PSG; assumes responsibility for medication procedures, completion of the e-diary and oversight of the activity/sleep watch; answers questions regarding his own sleep quality and distress 11)Have normal or clinically acceptable results of lab tests 12)Have normal or clinically acceptable results of physical exam, neurological exam, vital signs, and ECG 13)If female, not be of childbearing potential 14)Provide a blood sample for APOE genotyping V2: 15)TST ≤ 6.5 hours V3: 16)Mean TST 6.5 hours V4: 17)≥ 70% compliance with e-diary during Run-in Period 18)> 75% trial medication compliance between V2 and V4
Exclusion criteria
Exclusion criteria: 1)Resides in nursing home 2)MHIS Score > 4 3)History of stroke 4)relevant neurological disorder 5)history of seizures/epilepsy 6)History of sleep disorders 7)movement disorder 8)difficulty sleeping due to other condition 9)major depression 10)history of psychiatric condition 11)At imminent risk of self-harm or harm to others 12)alcoholism or drug dependency/abuse 13)has >2 alcoholic beverages/day or alcohol within 3h of bedtime or > 600 mg caffeine/day or after 4pm 14)Consumes >15 cigarettes/day 15)excessive daytime napping 16)uncontrolled, significant medical condition  17)ALT ≥ 3 x ULN; AST ≥ 3 x ULN; Total bilirubin ≥ 1.5 x ULN 18)creatinine clearance 3 chemical classes of drugs 24)Has donated blood products or had phlebotomy of >300 mL 25)malignancy 26)pregnant, attempting to get pregnant or nursing 27)Has a BMI > 40 kg/m2 28)participating or has participated in investigational study 29)family member of site or sponsor staff involved with trial 30)takes prohibited medications V2: 31)positive urine drug screen test,confirmed by central lab 32)positive alcohol breath test 33)Has underlying pathology of sleep confirmed by PSG V3: 34)PSG reveals evidence of exclusionary sleep disorder 35)positive urine drug screen 36)positive alcohol breath test
Countries
United States
Contacts
Public ContactAngela Chavez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed