EUCTR2013-005031-24-IT进行中（未招募）1 期
A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer Disease (AD)
Boehringer Ingelheim Italia S.p.A.0 个研究点目标入组 1,000 人开始时间: 2014年11月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male and female patients with an age of at least 55 years
- •- Body weight not lower than 50 kgs
- •- Patients with early signs of Alzheimer Disease
- •- Treatment naive patients or patients who have not received
- •prescribed drugs for treatment of AD (including acetyl cholinesterase
- •inhibitors (donepezil, galantamine, rivastigmine, tacrine, phenserine)
- •and Memantine
- •- Patients must have at least 6 years of formal education and fluency in
- •the test language as verbally confirmed by the patient and documented
- •by the study investigator.
- •- Patients must have given written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to any study procedures. All patients must be able to give informed consent personally and have capacity for such consent. An informed consent given by a legal representative will not be accepted.
- •- Patients must have a reliable study partner (per investigator
- •judgement, for instance a family member, guardian, partner etc.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •-Cognitive impairment with any etiology other than AD (based on
- •clinical data and/or current laboratory findings and/or a pre-existing MRI or CT of the brain which is not older than 12 months prior to screening visit) for example: neurosyphilis, craniocerebral trauma, small vessel disease
- •-Substantial concomitant cerebrovascular disease (defined by a history of a stroke / intracranial haemorrhagia) temporally related to the onset of worsening of cognitive impairment per investigator judgement
- •-Medical history of cancer (except for basal cell carcinoma) and/or
- •treatment for cancer within the last 5 years
- •-Medical history or diagnosis of any of symptomatic and
- •unstable/uncontrolled conditions per investigator judgement
- •-Severe renal impairment defined with a glomerular filtration rate
- •(GFR) < 30ml/min/1.73m2 in the screening central lab report
- •-Any other psychiatric disorders such as schizophrenia, or mental
- •retardation
- •-Any suicidal actions in the past 2 years (per investigator judgement
- •i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
- •-Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity
- •Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
- •-Previous participation in investigational drug studies of cognitive
- •impairment. Currently ongoing treatment with non-prescription
- •medications, vitamins or other nutritional formulations is allowed
- •however these should be captured in the electronic case report form (e-CRF)
- •-Significant history of drug dependence or abuse (including alcohol, as defined in Diagnostic and Statistical Manual of Mental Disorders [DSM-V] or in the opinion of the investigator) within the last two years, or a positive urine drug screen for cocaine, heroin, or marijuana.
- •-Known history of HIV infection
- •-Any planned surgeries requiring general anaesthesia, or
- •hospitalisation for more than 1 day during the study period
- •-Pre-menopausal women (last menstruation = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control
- •-For male patients: Men who are able to father a child, unwilling to be abstinent or to use an adequate form of effective contraception for the duration of study participation and for at least 28 days after treatment has ended.
- •-Use of any investigational drug or procedure for other indications
- •within 3 months or 6 half-lives (whichever is longer) prior to
- •randomization.
- •-Intake of medications which might interfere with the study drug
- •within 3 months prior to randomization and intended to be initiated during the duration of the trial
- •-Known hypersensitivity to the drug product excipients
研究者
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