PER-033-17尚未招募未知
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY, AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- A
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Ability to provide written consent signed by the patient (co-signed by the patient’s legally authorized representative, if required by the local regulations, guidelines, and independent Ethics Committee
- •2. Age 50−90 years old at screening, inclusive
- •3. Evidence of AD pathological process, as confirmed by CSF tau/Aβ42 or on amyloid PETscan by qualitative read by the core/central PET laboratory.
- •4.Probable AD dementia (consistent with NIA/AA core clinical criteria for probable AD dementia) or prodromal AD (consistent with the NIA/AAdiagnostic criteria and guidelines for mild cognitive decline due to AD)
排除标准
- •1. Any evidence of a condition other than AD that may affect cognition, including, but not
- •limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson’s disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium or hypoxia
研究者
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