NCT03980730终止2 期
Randomized, Double-blind, Placebo-controlled, Multicenter Studies to Evaluate the Safety and Efficacy of Azeliragon as a Treatment for Subjects With Mild Alzheimer's Disease and Impaired Glucose Tolerance
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 31
- 主要终点
- Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6
研究概览
简要总结
This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21 months (in Part 2).
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
- •Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression of disease
- •Mini Mental State Examination (MMSE) score of 21-26, inclusive
- •Clinical Dementia Rating global score of 0.5 or 1
- •Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) of 10 or more
- •Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD
- •Concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 2 months prior to screening
- •Hemoglobin A1c (HbA1c) 6.5% - 9.5%, inclusive
- •Caregiver willing to participate and be able to attend clinic visits with patient
- •Ability to ingest oral medications
排除标准
- •Significant neurological or psychiatric disease other than Alzheimer's disease
- •Previous clinical trial participation within 90 days of screening
- •Previous exposure to putative disease modifying therapy for Alzheimer's disease within 1 year of screening
- •History of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring current treatment
- •Women of childbearing potential
- •Uncontrolled blood pressure and/or blood pressure above 140/90
- •Participants receiving medications that may negatively impact cognitive function
- •History of diabetic ketoacidosis within the past year
- •History of chronic pancreatitis
- •Stage 4 kidney disease
- •Use of insulin therapy
研究组 & 干预措施
Azeliragon
Experimental
Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
干预措施: Azeliragon (Drug)
Placebo
Placebo Comparator
Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6
时间窗: Baseline to Month 6
The Alzheimer's Disease Assessment Scale - Cognitive Subscale 14 Item (ADAS-cog14) scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment
次要结局
- Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6(Baseline to Month 6)
- Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6(Baseline to Month 6)
- Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6(Baseline to Month 6)
- Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.(Baseline to Month 6)
研究者
研究点 (31)
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