EUCTR2015-005438-24-FR进行中（未招募）1 期
A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy and safety of orally administered BI 425809 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 980
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
入选标准
- •- Patients with signs of dementia of Alzheimer Type
- •- Male and female patients with an age of at least 55 years
- •- MMSE 15-26
- •- All patients must sign and date an Informed Consent Form personally
- •- Concomitant use of AChEIs is allowed but not required. Patients who are currently taking AChEIs are eligible as long as they have been using a stable dose for at least 3 months prior to screening and no change is foreseen for the duration of the study. This dose must be consistent with the product label in the concerned country. Patients who are not currently taking AChEIs but have taken them in the past are also eligible if AChEIs were stopped at least 3 months prior to screening.
- •- 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 a reliable study partner (per investigator judgement, for instance a family member, partner etc., guardian or, if applicable, a legal representative)
- •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 293
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 292
排除标准
- •- Dementia secondary to disorders other than Alzheimer's Disease
- •Dementia. Lewy body dementia or vascular or multi-infarct dementia as primary diagnosis is excluded. The above should be assessed based on clinical data,
- •current laboratory findings, and a MRI or CT of the brain.
- •If previous cranial imaging is not available or older than 12 months prior to screening then a CT or MRI needs to be performed at screening. Local regulations need to be checked if use of radiation for a cranial CT scan is allowed in the concerned country. If performing of a cranial CT is not allowed (e.g. Germany, France, United Kingdom), a MRI must be performed.
- •- Any central nervous system disease other than AD which according to the investigator may be associated with worsening of cognition. Patients with epileptic seizure in last 2 years should be excluded.
- •- A disease or condition which in the opinion of the investigator are likely to interfere with trial testing procedures or put the patient at risk when participating in this trial.
- •- Any documented active or suspected malignancy or history of
- •malignancy with need of concomitant treatment that interfere with the investigational product.
- •- Patients with life expectancy of less than 2 years are also excluded.
- •- Any other clinical condition that, in the opinion of the investigator,
- •would jeopardize patient safety while participating in this clinical trial.
- •- Severe renal impairment defined as a GFR < 30 mL/min/1.73 m2 in the screening central lab report.
- •- Haemoglobin less than 120 g/L (12g/dL) in men or 115g/L (11.5g/dL) in women in the screening lab report.
- •- Clinically significant uncompensated hearing loss in the judgment of
- •the investigator. Use of hearing aids is allowed.
- •- Any suicidal behaviour in the past 2 years (i.e. actual attempt,
- •interrupted attempt, aborted attempt, or preparatory acts or behaviour).
- •- Any suicidal ideation of type 4 or 5 in the 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).
- •- Known history of HIV infection.
- •- 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.
- •- Previous participation in investigational drug studies of dementia of
- •Alzheimer's Type within three months prior to screening. Having received active treatment in any other
- •study targeting disease modification of AD like Aß immunization and tau therapies. Previous participation in studies with non-prescription medications, vitamins other nutritional formulations or non-pharmacological treatments is allowed.
- •- Treatment with restricted medication.
- •- Planned elective surgery requiring general anaesthesia, or
- •hospitalisation for more than 1 day (requiring an overnight stay) during the study period.
- •- For females: Women who are of child bearing potential. Women not of childbearing potential are defined a
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