A Phase IB/IIA, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose, Parallel-Group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 following Intravenous Infusion in Patients with Prodromal or Mild To Moderate Alzheimer’s Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 99
- 试验地点
- 11
- 主要终点
- 1. Nature, frequency, severity, and timing of AEs, including – for Part 1 only – DLAEs. Significant assessments reported as AEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead ECG, and brain MRI findings (including the occurrence of vasogenic edema and hemorrhage) (Part 1-4)
研究概览
简要总结
To evaluate the safety and tolerability of multiple-ascending dose of RO7126209 (Part 1 and 2), of intravenous dose of RO7126209 (Part 3) and of long-term administration of IV doses (Part 4) To evaluate the pharmacodynamic (PD) effects of multiple doses of RO7126209 (Part 3)
研究设计
- 分配方式
- Randomized
- 主要目的
- A Phase Ib/iia To Investigate Ro7126209 In Patients With Alzheimer’s Disease
- 盲法
- Double (Analyst, Monitor, Subject, Investigator, Carer)
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
- 否
入选标准
- •Age 50 to 85 years (inclusive) at screening
- •Probable mild to moderate AD dementia (consistent with NIA-AA core clinical criteria for probable AD dementia) (McKhann et al 2011) or prodromal AD (consistent with the NIA-AA diagnostic criteria and guidelines for mild cognitive impairment due to AD) (Albert et al 2011)
- •Mini-Mental State Examination (MMSE) score of 18 to 28 points, inclusive, within 84 days before baseline
- •Clinical Dementia Rating-Global Score (CDR-GS) of 0.5, 1, or 2 within 84 days before baseline
- •Positive amyloid PET scan (cut-off: > 50 Centiloid units) within 12 months before baseline
- •In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least 8 weeks prior to baseline and until randomization
排除标准
- •Any condition other than AD that may affect cognition
- •Significant cerebral abnormalities
- •History or presence of intracranial mass (e.g., glioma, meningioma) that could potentially impair cognition
- •History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder, Cancer, unless cured or currently not needing treatment. Note: History of major depression is acceptable, if participant has had no episode within the past year, or is considered in remission, or depression is controlled by treatment
- •History of any clinically significant hematological diseases, clinically significant ophthalmologic disease or chronic kidney disease
- •Atrial fibrillation, cardiovascular disease or uncontrolled hypertension
研究组 & 干预措施
Placebo Trontinemab
干预措施: Placebo Trontinemab (Drug)
Flortaucipir F18
干预措施: Flortaucipir F18 (Drug)
Trontinemab
干预措施: Trontinemab (Drug)
结局指标
主要结局
1. Nature, frequency, severity, and timing of AEs, including – for Part 1 only – DLAEs. Significant assessments reported as AEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead ECG, and brain MRI findings (including the occurrence of vasogenic edema and hemorrhage) (Part 1-4)
1. Nature, frequency, severity, and timing of AEs, including – for Part 1 only – DLAEs. Significant assessments reported as AEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead ECG, and brain MRI findings (including the occurrence of vasogenic edema and hemorrhage) (Part 1-4)
2. Change from baseline in brain amyloid load, as measured by amyloid PET scan (Part 3)
2. Change from baseline in brain amyloid load, as measured by amyloid PET scan (Part 3)
次要结局
- 3. CSF concentration of RO7126209
- 4. Incidence and titer of anti-RO7126209 ADAs over time
- 1. Change from baseline in brain amyloid load, as measured by amyloid PET scan (Part 1, 2 and 4 only)
- 2. Plasma Concentration of RO7126209 at specified timepoints
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG