JPRN-jRCT2031220468已完成3 期
A Phase III, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease
Gesine Respondek, M.D.0 个研究点目标入组 24 人开始时间: 2022年11月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- 年龄范围
- >= 60age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Willing and able to comply with the study protocol and complete all aspects of the study [including cognitive and functional assessments, physical and neurological examinations, MRI, CSF collection, genotyping, and positron emission tomography (PET) imaging].
- •- Cognitively unimpaired with a screening clinical dementia rating global score (CDR-GS) of 0, and Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) >=80.
- •- Evidence of cerebral amyloid accumulation.
- •- Participants who have an available person (referred to as a study partner).
- •- Fluent in the language of the tests used at the study site.
- •Adequate visual and auditory acuity, sufficient to perform neuropsychological testing (eye glasses and hearing aids are permitted).
- •- Agreed not to participate in other interventional research studies for the duration of this trial.
- •- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 17 weeks after the final dose of study treatment.
排除标准
- •- Any evidence of an underlying neurological or neurodegenerative condition that may lead to cognitive impairment other than AD.
- •- Clinical diagnosis of mild cognitive impairment (MCI), prodromal AD, or any form of dementia.
- •- History or presence of intracranial or intracerebral vascular malformations, aneurysm, subarachnoid hemorrhage, or intracerebral macrohemorrhage.
- •- History of major depression, schizophrenia, schizoaffective disorder, or bipolar disorder.
- •- History or presence of systemic autoimmune disorders that may lead to progressive neurological impairment with associated cognitive deficits.
- •- Current COVID-19 infection.
- •- Evidence of folic acid or vitamin B-12 deficiency.
- •- Any passive immunotherapy (Ig) or other long-acting biologic agent to prevent or postpone cognitive decline within 1 year of screening.
- •- Any other investigational treatment within 5 half-lives or 6 months (whichever is longer) prior to screening.
- •- Typical/Atypical anti-psychotic medications or neuroleptic medications.
- •- Anticoagulation medications within 3 months of screening with no plans to initiate any prior to randomization.
- •- Any previous treatment with cholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists are exclusionary at screening.
- •- Pregnant or breastfeeding, or intending to become pregnant during the study or within 17 weeks after the final dose of gantenerumab.
- •- Impaired coagulation.
- •- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins, including gantenerumab and gantenerumab excipients.
研究者
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