A Randomized, Placebo-Controlled, Double-Blind, 24-Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline in the ADAS-Cog 14 memory box score at Weeks 12 and 24
研究概览
简要总结
Randomized, Placebo-Controlled, Double-Blind, 24-Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults aged ≥55 and ≤85 years at the time of written consent
- •Subjects with a Korean Mini-Mental State Examination (K-MMSE) score of 20 to 28
- •Have a global Clinical Dementia Rating (CDR) score of 0.5 to 1 and a CDR Memory Box score of 0.5 or greater
- •Subjects who test positive for amyloid on Positron Emission Tomography (PET)
排除标准
- •Subjects with clinically significant diseases other than Alzheimer's disease that may confound cognitive assessment
- •History of central nervous system (CNS) diseases
- •Active central nervous system (CNS) infection capable of affecting cognitive function, or a history of infection resulting in neurological sequelae
- •Structural brain abnormalities identified on screening MRI that could account for cognitive impairment
- •Abnormal thyroid function identified at screening
- •Vitamin B12 deficiency identified at screening
- •History of seizure disorder or epilepsy
- •History or suspicion of alcohol or substance abuse/dependence
- •History of psychiatric disorders, including schizophrenia, bipolar disorder, or clinically significant major depressive disorder, with current active symptoms
- •History of malignancy diagnosed or recurrent within 5 years prior to screening
- •History of a major cardiovascular event within 12 months prior to screening
- •Cardiovascular disease requiring the administration of anticoagulants
- •Severe or active infectious disease requiring treatment with antibiotics or antivirals within 4 weeks prior to randomization, or expected to require such treatment during the study period
- •Clinically significant gastrointestinal disorders within 3 months prior to screening, or conditions that may lead to malabsorption
- •Treatment with any disease-modifying therapy for Alzheimer's disease within 1 year prior to screening
- •Initiation or dosage/regimen changes of symptomatic treatments for dementia within 12 weeks prior to screening
- •Chronic use of medications acting on the CNS or those that may affect cognitive function within 8 weeks prior to screening
- •Regular use of medications that may alter the gut microbiota within 4 weeks prior to screening
结局指标
主要结局
Change from baseline in the ADAS-Cog 14 memory box score at Weeks 12 and 24
时间窗: Baseline, Week 12, Week 24
Change from baseline in the ADCS-MCI-ADL score at Weeks 12 and 24
时间窗: Baseline, Week 12, Week 24
Change from baseline in the K-MMSE score at Weeks 12 and 24
时间窗: Baseline, Week 12, Week 24
Change from baseline in the ADAS-Cog 14 total score at Weeks 12 and 24
时间窗: Baseline, Week 12, Week 24
Change from baseline in the Global Clinical Dementia Rating (CDR) score at Week 24
时间窗: Baseline, Week 24
Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at Week 24
时间窗: Baseline, Week 24
Change from baseline in amyloid PET imaging biomarkers at Week 24
时间窗: Baseline, Week 24
Change from baseline in blood-based Alzheimer's disease-related biomarkers at Week 24
时间窗: Baseline, Week 24
Change from baseline in blood cytokine levels at Week 24
时间窗: Baseline, Week 24
次要结局
未报告次要终点