NCT00606164Unknown2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bryostatin 1 in Patients With Mild to Moderate Alzheimer's Disease
Blanchette Rockefeller Neurosciences Insitute1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The main purpose of this study is find out how safe a single dose of bryostatin 1 is in patients with Alzheimer's Disease (AD). This study is also being done 1) to determine how effective a single dose of bryostatin 1 is in the treatment of AD, 2) to find out what happens to bryostatin 1 once it enters the body by measuring the levels of bryostatin 1 in blood, and 3) to measure a substance in the blood (protein kinase C) that may help to better understand how bryostatin 1 works.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 50 yrs or older. Females must be of non-childbearing potential (surgically sterilized or at least 2 yrs post-menopausal)
- •Must have a cognitive deficit present for at least 1 yr & meet DSM-IV-TRTM criteria for AD & meet NINCDS/ADRDA criteria for the presence of probable AD
- •Severity of AD must be mild to moderate, documented with a MMSE score of 12-26
- •Has a CT scan or MRI scan within the prior 12 months, which is compatible with a diagnosis of probable AD
- •Ability to walk, at least with an assistive device
- •Vision & hearing sufficient to comply with testing
- •Normal cognitive & social functioning prior to onset of dementia
- •Consistent caregiver to accompany patient to assessment visits
- •Sufficient basic education to be able to complete the cognitive assessments
- •Living outside an institution
- •Informed consent signed & dated by patient or legal representative
- •Has provided written authorization for the use & disclosure of protected health information
排除标准
- •Dementia due to any condition other than AD, including vascular dementia (modified Hachinski Ischemic Scale ≥ 5; positive NINDS-AIREN criteria)
- •Evidence of clinically significant unstable cardiovascular, renal, hepatic, gastrointestinal, neurological, or metabolic disease within the past 6 months (as determined by medical history, ECG results, chest x-ray, or physical examination)
- •Use of any drug within 14 days prior to randomization unless the dose of the drug & the condition being treated have been stable for at least 30 days & are expected to remain stable during the study & neither the drug nor the condition being treated is expected to interfere with the study endpoints
- •Any medical or psychiatric condition that may require medication or surgical treatment during the study
- •Life expectancy less than 6 months
- •Any other screening laboratory values outside the normal ranges that are deemed clinically significant by the investigator
- •Use of an investigational drug within 30 days prior to the screening visit or during the entire study
- •Significant neurological disease other than AD, including cerebral tumor, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, & other entities
- •Major depression according to DSM-IV
- •Psychotic episodes requiring hospitalization or antipsychotic therapy for more than 2 weeks within the past 10 yrs, not linked to AD
- •Agitation sufficient to preclude participation in this trial
- •Alcohol or drug dependence diagnosed within the past 10 yrs
- •Epilepsy or anti-epileptic drug therapy
- •Abnormal laboratory tests that might point to another etiology for dementia: serum B12, folate, thyroid functions, electrolytes, syphilis serology
- •Musculoskeletal diseases that could interfere with assessment
- •Acute or poorly controlled medical illness: blood pressure> 180 mmHg systolic or 100 mmHg diastolic; myocardial infarction within 6 months; uncompensated congestive heart failure (NYHA Class III or IV), severe renal, hepatic or gastrointestinal disease that could alter drug pharmacokinetics; blood glucose > 180 mg/dl on repeated testing at entry into study or need for insulin therapy
- •Previous randomization in this trial or participation in another investigational trial < 2 months prior to randomization
- •Likelihood, according to clinical judgment, of being transferred to a nursing home within 6 months
- •Change in dosage of any concomitant antidepressant within 30 days prior to randomization
- •Lack of caregiver
- •Pregnant or lactating females
- •Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedures outlined in this protocol
- •HIV positive
- •Hepatitis B or C positive
- •Concomitant use of medications other than AD or antidepressant medications for which the dose regimens are stabilized for at least 30 days prior to enrollment in study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
10 ug/m2 Bryostatin
Experimental
干预措施: Bryostatin for Injection (Drug)
15 ug/m2 Bryostatin
Experimental
干预措施: Bryostatin for Injection (Drug)
结局指标
主要结局
Adverse Events
时间窗: 4-weeks
Alzheimer's Disease Assessment Scale
时间窗: 4-weeks post dose
Clinician's Interview Based Impression of Change
时间窗: 4-weeks post dose
次要结局
- Hematology(48 hrs and 4-weeks post dose)
- Alzheimer's Disease Assessment Scale(24, 48, and 72 hrs post dose)
- Clinician's Interview Based Impression of Change(24, 48, and 72 hrs post dose)
- Clinical Dementia Rating Battery(24, 48, and 72 hrs post dose and 4-weeks post dose)
- Alzheimer's Disease Cooperative Study - Activities of Daily Living(24, 48, and 72 hrs post dose and 4-weeks post dose)
- Severe Impairment Battery(24, 48, and 72 hrs post dose and 4-weeks post dose)
- Hopkins Verbal Learning Test-Revised(24, 48, and 72 hrs post dose and 4-weeks post dose)
- Temperature(48 hrs and 4-weeks post dose)
- Respiratory rate(48 hrs and 4-weeks post dose)
- Blood pressure(15, 30, and 60 minutes after start of study drug infusion, and at 1, 2, 4, 8, 12, 24, 48, and 72 hrs post infusion and 4-weeks post infusion)
- Heart rate(15, 30, and 60 minutes after start of study drug infusion, and at 1, 2, 4, 8, 12, 24, 48, and 72 hrs post infusion and 4-weeks post infusion)
- Electrocardiogram(15, 30, and 60 minutes after start of study drug infusion, and at 1, 2, 4, 8, 12, and 24 hrs post infusion and 4-weeks post infusion)
- Physical Exam(48 hrs and 4-weeks post dose)
- Blood chemistry(48 hrs and 4-weeks post dose)
- Urinalysis(48 hrs and 4-weeks post dose)
- Pharmacokinetics(Blood draws at baseline, during the study drug infusion (15, 30, and 60 minutes after start of infusion), and at 20 minutes, 1 hr, 2 hrs, 6 hrs, 24 hrs, 48 hrs, and 72 hrs post infusion)
- Protein kinase C activity (pharmacodynamics)(Blood draws at baseline, during the study drug infusion (15, 30, and 60 minutes after start of infusion), and at 20 minutes, 1 hr, 2 hrs, 6 hrs, 24 hrs, 48 hrs, and 72 hrs post infusion)
研究者
研究点 (1)
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