2022-503148-41-00招募中2 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)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 345
- 试验地点
- 45
- 主要终点
- Percentage of subjects with at least 1 drug-related AE or drug-related serious adverse event (SAE) between Baseline and Week 48
研究概览
简要总结
Safety To evaluate the safety and tolerability of multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD, based on incidence of drug-related adverse events (AEs).
Efficacy To evaluate the efficacy of multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD, based on the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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 National Institute on Aging and Alzheimer’s Association (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
结局指标
主要结局
Percentage of subjects with at least 1 drug-related AE or drug-related serious adverse event (SAE) between Baseline and Week 48
Percentage of subjects with at least 1 drug-related AE or drug-related serious adverse event (SAE) between Baseline and Week 48
Change from Baseline to Week 48 in global outcome as measured by CDR-SB.
Change from Baseline to Week 48 in global outcome as measured by CDR-SB.
次要结局
- Percentage of subjects with AEs and SAEs from Baseline until End of Study (EoS)
- Percentage of subjects with ARIA-E and ARIA-H from Baseline until End of Treatment (EoT)
- Percentage of subjects who stopped treatment due to AEs or SAEs from Baseline until EoT
- Change from baseline to Week 48, of: • Alzheimer's disease cooperative study - activities of daily living inventory (ADCS-ADL) • Alzheimer disease assessment scale - cognitive subscale, 13 tests (ADAS-Cog 13)
- Change from Baseline to EoT of: Cerebrospinal fluid (CSF) concentrations of AD‐related biomarkers including, but not limited to, ratio Aβ 1-42/1-40, p-tau, t-tau, Aβ oligomers, tau oligomers
- Change from Baseline to EoT of: Plasma concentrations of AD-related biomarkers including, but not limited to, ratio Aβ 1-42/1-40, p-tau, t-tau, neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP) and Aβ oligomers
- PRI-002 plasma concentrations over time
- Change from Baseline to EoT of: Mini mental state examination (MMSE) scores
- Change from Baseline to EoT of: • CDR-SB • ADCS-ADL • ADAS-Cog 13
- Change from Baseline to EoT of: Relationship between changes in CSF and plasma biomarkers and clinical changes (CDR‐SB, ADCS‐ADL, ADAS‐Cog 13, MMSE)
- Relationships between PRI‐002 plasma concentrations and clinical changes (CDR‐SB, ADCS‐ADL, ADAS‐Cog 13, MMSE) and safety endpoints (AEs and SAEs)
研究者
Prof. Dr. Dieter Willbold
Scientific
Prinnovation GmbH
研究点 (45)
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