A Single-centre, Randomized, Placebo-controlled, Double-blind, Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
研究概览
简要总结
Patients with mild cognitive impairment due to Alzheimer's disease (MCI due to AD) are at high risk to develop Alzheimer´s dementia. The therapeutic agent Contraloid has the potential to influence the chronic neurodegenerative process of AD. As Contraloid was so far only administered to healthy subjects, the rational of the proposed study is first to collect safety data in patients diagnosed with MCI due to AD, as the absorption, distribution, metabolism and excretion processes may be altered by disease, aging, comorbidities and concomitant drug therapies. Additionally, the design of a subsequent phase II study will be based on the data of this study. The results of the exploratory analyses will enable power calculations and the identification of the most useful and reliable biomarkers for the subsequent proof of concept phase II study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with MCI due to AD according to DSM-V
- •Age between 50 and 80 years (male and female)
- •MMSE score 22-30
- •Written informed consent (according AMG §40 (1) 3b)
- •Level of Aβ-oligomers: mind. 1fM
- •CSF according to diagnosis (p-tau > 62 pg/ml, total CSF Aβ 1-42/1-40 ratio ≤ 0.055)
- •3 months prior to screening stable medication
- •Females without childbearing potential
排除标准
- •History of seizures
- •History of stroke or TIA
- •Unstable medical, neurological or psychiatric condition
- •Current treatment with one of the following substances:
- •Typical antipsychotic or neuroleptic medication within 6 months of screening
- •Anti-coagulation medications within 3 months of screening
- •Chronic use of opiates or opioids (including long-acting opioid medication) within 3 months of screening
- •Stimulant medications (amphetamine, methylphenidate preparations, or modafinil) within 1 month of screening and throughout the study
- •Chronic use of benzodiazepines, barbiturates, or hypnotics from 3 months before screening
- •Persons who are legally detained in an official institution
- •Persons who may be dependent on the sponsor, the investigator or the trial site
- •Persons without caregiver
- •Participation in other clinical trials according to AMG (1 month before the time of this trial)
- •Persons showing EEG abnormalities
研究组 & 干预措施
Contraloid acetate
300 mg Contraloid/participant administered orally (for 28 days) as a single daily dose.
Other Name: PRI-002
干预措施: Contraloid acetate (Drug)
Placebo
300 mg Placebo (Microcrystalline cellulose)/participant administered orally (for 28 days) as a single daily dose.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
时间窗: From baseline (day 1) to follow-up (day 56)
Number of Adverse Events
Safety: Number of Participants with abnormal laboratory values (urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST)
时间窗: From baseline (day 1) to follow-up (day 56)
Laboratory values: urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST
Safety: Number of Participants with abnormal ECG values
时间窗: From baseline (day 1) to follow-up (day 56)
ECG
次要结局
- Pharmacokinetics: Peak Plasma Concentration (Cmax)(pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28)
- Pharmacokinetics: The time at which Cmax is observed (Tmax)(pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28)
- Pharmacokinetics: Terminal elimination half-life (t1/2) in plasma(pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28)
研究者
Oliver Peters, MD
Principal Investigator
Charite University, Berlin, Germany