NCT00422981已完成2 期
A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Effect on Cognitive Function of AL-108 After 12 Weeks of Intranasal Administration in Subjects With Mild Cognitive Impairment
Allon Therapeutics16 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 16
- 主要终点
- Change from baseline to Week 12 on the Composite Memory Variable
研究概览
简要总结
The purpose of this study is to find out if different doses of Investigational Drug are safe, tolerable, and if they have an effect on Mild Cognitive Impairment (MCI).
详细描述
Pre-Clinical experiments indicate the AL-108 compound has neuroprotective, cognitive protective and neurotrophic properties; therefore, the compound could be tested in a variety of human diseases. Human diseases include Cognitive impairment associated with aging or neurodegenerative diseases such as Alzheimer's Disease.
This clinical trial aims at providing the dose rationale as well as safety and tolerability information for AL-108 as evaluated after 12 weeks of intranasal administration in subjects with Mild Cognitive Impairment (MCI).
There are currently no drugs approved for the treatment of MCI nor accepted treatment or standard treatment approach.
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is male or female, at 55-85 years of age (inclusive) at screening
- •Self-reported memory complaint, corroborated by spouse or companion as appropriate.
- •Wechsler Memory Scale III (WMS-III) age-adjusted Logical Memory II score ≤
- •Mini-Mental State Exam (MMSE) ≥
- •Center for Epidemiologic Studies-Depression (CES-D) score <
- •Normal thyroid function, defined as TSH, T3 and T4 within normal limits.
- •Agree not to consume alcoholic beverages within 8 hours of each study visit.
- •Willing and able to sign informed consent and complete the CTB and all other tests and procedures as listed in the protocol.
- •Fluently reads and speaks English.
- •Female subjects must be surgically sterile or post-menopausal for at least 2 years. If <2 years post-menopausal, then a follicle stimulating hormone (FSH) ≥40 mIU/mL must be obtained.
排除标准
- •Subjects who have any significant, untreated psychiatric illness or any CNS condition (such as schizophrenia, Parkinson's disease, stroke, etc.) that could interfere with the study evaluations or procedures or which poses an additional risk. Subjects with a history of uncomplicated depression may participate if in remission and on a stable dose of antidepressant medication for at least 2 months.
- •History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- •History of alcohol or substance abuse or dependence within the past year.
- •Acute infective sinusitis.
- •History or presence of an abnormality of the external or internal structures of the nose or nasopharynx, except for surgical correction of the nasal septum or a "broken nose" at least 2 years previously, or surgical repair of cleft palate when <30 years of age.
- •Use of medications that are known to cause frank obtundation of cognition
- •Use of any approved or investigational medication for Alzheimer's Disease within 3 months of screening
- •History of or current significant systemic disease judged to interfere with the study evaluations or likely to be a safety concern.
- •Untreated sleep apnea or treatment for sleep apnea for <3 months.
- •Abnormal clinical laboratory test results, specifically: Alanine transaminase (ALT) or aspartate transaminase (AST) >2 х the upper limit of normal (ULN),Hematology <80% the lower limit of normal, Creatinine ≥2 mg/dL and ,Other clinical laboratory values or vital signs considered clinically significant in the opinion of the Investigator.
- •Treatment with any investigational drug, biologic, or device within the previous 30 days prior to screening.
- •Surgery involving general anesthesia within the past 3 months or planned surgery requiring general anesthesia during the study period.
研究组 & 干预措施
AL-108 5 mg
Active Comparator
5 mg QD
干预措施: AL-108 (Drug)
AL-108 15 mg
Active Comparator
15 mg BID
干预措施: AL-108 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to Week 12 on the Composite Memory Variable
时间窗: 12 weeks
次要结局
- Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16(16 weeks)
- Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).(16 weeks)
研究者
研究点 (16)
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