PER-022-16已完成未知
A PHASE III RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF SUVOREXANT (MK-4305) FOR THE TREATMENT OF INSOMNIA IN SUBJECTS WITH ALZHEIMER’S DISEASE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,0 个研究点目标入组 68 人开始时间: 2016年9月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •15)TST ≤ 6.5 hours
- •16)Mean TST < 6 hours (V2 and V3) and neither > 6.5 hours
- •17)≥ 70% compliance with e-diary during Run-in Period
- •18)> 75% trial medication compliance between V2 and V4
排除标准
- •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
- •31)positive urine drug screen test,confirmed by central lab
- •32)positive alcohol breath test
- •33)Has underlying pathology of sleep confirmed by PSG
- •34)PSG reveals evidence of exclusionary sleep disorder
- •35)positive urine drug screen
- •36)positive alcohol breath test
研究者
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