2023-506170-12-00招募中2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 251
- 试验地点
- 39
- 主要终点
- Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score
研究概览
简要总结
Investigation of the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer’s Disease (AD)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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 CDR-Memory 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 Aβ accumulation by either positive amyloid assessment by either positron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aβ1-42 ratio assessment
排除标准
- •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 activitiy - 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
结局指标
主要结局
Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score
Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score
次要结局
- Incidence of treatment-emergent adverse events (TEAEs)
- Incidence of treatment-emergent serious adverse events (TESAEs)
- Incidence of TEAEs leading to discontinuation or death
- Incidence of Drug-related TEAEs
- Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Change from Baseline to Week 56 and Week 80 on indices of tau burden in the brain as measured by [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET)
- Change from Baseline to Week 56 and Week 80 in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)
- Change from Baseline to Week 56 and Week 80 in Amsterdam-Instrumental Activities of Daily Living (AiADL)
- Change from Baseline to Week 56 and Week 80 in Mini-Mental State Examination (MMSE) total score
- Serum concentrations of bepranemab over the 80- week Double-blind Treatment Period
研究者
UCB Cares
Scientific
UCB Biopharma
研究点 (39)
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