CTIS2022-503148-41-00招募中1 期
Randomised, double-blind, placebo-controlled study to assess safety and efficacy of PRI-002 in patients with MCI or mild dementia due to Alzheimer’s disease (AD) - PRI-002-04
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 305
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Signed and dated written informed consent obtained from the subject and study companion in accordance with applicable regulations, Male or female, aged 55 to 80 years, inclusive, For female subjects: not being of child-bearing potential, Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive, Diagnosed with MCI due to AD or mild dementia due to AD, according to the NIA-AA criteria, MMSE score of 22 to 30, inclusive, Repeatable battery for the assessment of neuropsychological status - delayed memory index (RBANS-DMI) score =85, CDR global score of 0.5 or 1 with a memory score =0.5, Confirmation of AD diagnosis, by CSF biomarker profile reflecting AD, according to NIA-AA, or existing positive amyloid positron emission tomography (PET) evidence
排除标准
- •History or evidence of any other central nervous system (CNS) disorder(s) that could be interpreted as a cause of cognitive impairment or dementia
研究者
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