ESTUDIO CLINICO DE FASE III, RANDOMIZADO, CONTROLADO CON PLACEBO, DESTINADO A INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE SUVOREXANT (MK-4305) PARA EL TRATAMIENTO DEL INSOMNIO EN SUJETOS CON ENFERMEDAD DE ALZHEIMER
- Conditions
- -G470 Disorders of initiating and maintaining sleep [insomnias]-G30Disorders of initiating and maintaining sleep [insomnias]G30G470
- Registration Number
- PER-022-16
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 68
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 hours (V2 and V3) and neither > 6.5 hours
V4:
17)≥ 70% compliance with e-diary during Run-in Period
18)> 75% trial medication compliance between V2 and V4
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 <30 mL/min
19)vitamin B12 or folate deficiency or Abnormal thyroid function
20)hepatitis or liver disease active
21)Positive urine drug screen
22)known allergy or hypersensitivity to suvorexant
23)hypersensitivity to >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method