A 28-Day Study of GAL-101 in Participants With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This Phase 2a study will evaluate the safety and tolerability of GAL-101 in approximately 100 participants with mild to moderate Alzheimer's disease associated with amyloid-beta pathology. Participants will be randomly assigned to receive either 1200 mg of GAL-101 salt or matching placebo tablets by mouth once daily for 28 days. Neither the participants nor the study team will know which treatment each participant receives during the study.
The study will also explore whether GAL-101 affects brain-wave activity measured using quantitative electroencephalography, Alzheimer's disease-related biomarkers in cerebrospinal fluid, and performance on cognitive tests. Blood and cerebrospinal fluid samples will be collected to evaluate how GAL-101 is absorbed and distributed in the body.
详细描述
GAL-101 oral was previously evaluated in a Phase 1 study in healthy adult and elderly participants (ClinicalTrials.gov Identifier: NCT07780604)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 50 to 85 years, inclusive.
- •Clinical diagnosis of Alzheimer's disease at the mild or moderate dementia stage (Stages 4 or 5) according to the 2018 National Institute on Aging and Alzheimer's Association criteria
- •Evidence of amyloid-beta pathology based on cerebrospinal fluid biomarkers, amyloid-beta positron emission tomography, or plasma phosphorylated tau
- •Evidence of cognitive decline during the previous year.
- •Availability of a reliable trial partner, caregiver, or legal representative who has contact with the participant for at least 10 hours per week and can support study participation.
- •Able and willing to provide informed consent and comply with study requirements.
- •In sufficiently good health, in the investigator's opinion, to participate in the study.
- •If receiving an acetylcholinesterase inhibitor or memantine, treatment must be at a stable dose for the protocol-specified period.
排除标准
- •A neurological, psychiatric, cerebrovascular, or other medical condition that could explain the participant's cognitive impairment, interfere with study assessments, or create an unacceptable safety risk.
- •Previous treatment with anti-amyloid-beta immunotherapy.
- •Participation in another interventional clinical study or receipt of an investigational drug within 3 months before screening.
- •Use of prohibited medications or substances that could affect cognition, electroencephalography assessments, safety, or interpretation of the study results.
- •Clinically significant or unstable cardiovascular, respiratory, renal, hepatic, metabolic, infectious, or malignant disease.
- •Active major depression, schizophrenia, bipolar disorder, or clinically significant suicide risk.
- •Known or suspected hypersensitivity to GAL-101, placebo, or their components.
- •A scalp condition that would prevent adequate electroencephalography assessment.
- •Inability to comply with the study schedule or procedures.
- •Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From the first dose through 4 weeks after the last dose, approximately 8 weeks
Number of participants who experience one or more adverse events following administration of GAL-101 salt or placebo.
次要结局
- Change From Baseline in Global Alpha-Band Corrected Amplitude Envelope Correlation(Baseline to the end of the 28-day treatment perio)