Synaptic Therapy Alzheimer's Research Trial (START): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease Over 18 Months.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 540
- 试验地点
- 77
- 主要终点
- Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
研究概览
简要总结
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.
详细描述
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo for approximately 18 months (72 weeks) in approximately 540 participants diagnosed with early Alzheimer's disease
Participants will be randomized 1:1:1 to receive either 100mg or 200mg of CT1812 or placebo. CT1812 or placebo will be administered as 2 capsules to be taken orally once daily.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ages 50-85 years.
- •Diagnosis of either MCI due to AD or mild AD dementia.
- •MMSE 20-30 (inclusive).
- •Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
- •Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.
排除标准
- •Screening MRI of the brain indicative of significant abnormality.
- •Clinically significant abnormalities in screening laboratory tests.
- •Clinical or laboratory findings consistent with:
- •Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
- •Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
- •Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
- •A participant known to be actively infected with hepatitis B or hepatitis C at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor.
- •A current DSM-V diagnosis of active major depression or GDS > 6, schizophrenia, or bipolar disorder.
研究组 & 干预措施
Placebo
Placebo, n=180 group
干预措施: Placebo (Drug)
CT1812 100 mg
CT1812 at a dose of 100 n=180 group
干预措施: CT1812 (Drug)
CT1812 200 mg
CT1812 at a dose of 300mg, n=180 group
干预措施: CT1812 (Drug)
结局指标
主要结局
Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
时间窗: 18 months
The Clinical Dementia Rating (CDR) is a clinical scale that describes 5 levels of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia as absent, questionable, mild, moderate, or severe (global CDR scores of 0, 0.5, 1, 2, or 3, respectively). The score is based on interviews with the participant and study partner, using a structured interview. A sum of boxes score (CDR-SB) provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.
次要结局
- Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)(18 months)
- Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.(18 months)
- Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.(18 months)
- Plasma measures of Aβ fragments, ptau, and Neurofilament light (NfL)(18 months)
- Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change(18 months)