A multi-centre, double-blind, parallel-group, randomized controlled study to investigate the efficacy, safety and tolerability of orally administred BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer's disease. - BI 409306 in patients with prodromal Alzheimer Disease

Boehringer Ingelheim0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Written Informed Consent, 55 years or older, minimal 50 kg.
•Patients with diagnosis of prodromal AD in accordance with the recommendation of the International Working Group (IWG), Dubois et al. 2007
•Symptoms noticed by the patients
•Cognitive testing confirming prodromal symptoms
•Biomarker evidence of AD pathology
•No evidence of other forms of dementia
•No other concomitant illness or medication which could confound or prohibit completion in the trial by the patient

•Other forms of dementia, or a psychiatrical disorder or severe depression
•Substantial concomitant cerebrovascular disease, Medical history of cancer, Significant ischemic heart disease, Significant gastrointestinal disorders, Uncontrolled endocrine disease, Significant pulmonary disease predisposing to hypoxia, Immunological disorders, Unstable/uncontrolled haematological disease, Any other systemic or multiple organ dysfunctions, Severe renal impairment, Any suicidal actions in the past 2 years, Previous participation in investigational drug studies of mild cognitive impairment within three months prior to screening, HIV or syphilis infection confirmed by a central lab test, intake of restricted medications as per protocol, pre-menopausal women not able or willing to take appropriate birth control, breast feeding women.

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