A PATIENT- AND INVESTIGATOR-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF BEPRANEMAB (UCB0107) IN STUDY PARTICIPANTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE (AD), FOLLOWED BY AN OPEN-LABEL EXTENSION PERIOD - NA

CB Biopharma SR0 个研究点目标入组 450 人开始时间: 2021年8月30日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•- 50 to 80 years of age
•- diagnosis of prodromal/mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD according to National Institute of Aging-Alzheimer's Association (NIA-AA)
•- a global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and CDRMemory Box (CDRMB) score =0.5 at Screening and Baseline
•- Score of =85 for the delayed recall domain of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at Screening
•- Mini-Mental State Examination (MMSE) score =20 at Screening
•- Participant has an identified informant that has and will maintain sufficient contact (minimum of 5 hours per week) with the participant to be able to provide accurate information on the participant's cognitive, functional, and emotional states and of the participant's personal care
•- At least 6 years of formal education after the age of 5 or work experience to exclude mental deficits other than prodromal or mild AD dementia
•- evidence of cerebral Aß accumulation by either positive amyloid assessment by either positron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aß1-42 ratio assessment
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 350

•- any evidence of a condition that may affect cognition other than AD
•- contraindications to PET imaging
•- Inability to tolerate or contraindication to magnetic resonance imaging
•- any serious medical condition or abnormality that in the opinion of the investigator would preclude safe participation in and completion of the study or interfere with study assessments and/or study interpretation
•- alcohol or drug abuse within 2 years of screening
•- use of any experimental therapy within the past 6 months (or 5 half lives) prior to screening - previous treatment with medication intended to treat a neurodegenerative disorder (other than AD) within 1 year of screening
•- chronic daily treatment with atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally acting antihistamine or anticholinergic
•- received treatment with monoclonal antibodies (mAbs), cytokines, immunoglobulins, or other blood products within 3 months or 5 half-lives (whichever is longer) prior to first dosing

发起方

CB Biopharma SR