A PHASE 2 DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS/ PHARMACODYNAMICS OF PF-04360365 IN MILD TO MODERATE ALZHEIMER'S DISEASE PATIENTS

Pfizer4 个研究点分布在 1 个国家目标入组 36 人开始时间: 2009年8月6日最近更新: 2024年4月19日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Pfizer
入组人数: 36
试验地点: 4
主要终点: Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.

研究设计

研究类型: Interventional
分配方式: Randomized
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

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

•Males or females of non childbearing potential, age > or =
•Diagnosis of probable Alzheimer's disease, consistent with criteria from both:
•National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
•Diagnostic and Statistical Manual of Mental Disorders (DSM IV).
•Mini-mental status exam score of 16-26 inclusive.
•Rosen-Modified Hachinski Ischemia Score of < or = 4.

排除标准

•Diagnosis or history of other demential or neurodegenerative disorders.
•Diagnosis or history of clinically significant cerebrovascular disease.
•Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities.
•History of autoimmune disorders.
•History of allergic or anaphylactic reactions.

研究组 & 干预措施

PF-04360365 10 mg/kg

Experimental

干预措施: PF-04360365 10 mg/kg (Biological)

PF-04360365 7.5 mg/kg

Experimental

干预措施: PF-04360365 7.5 mg/kg (Biological)

placebo

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities

时间窗: Baseline up to Month 18

Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral edema, cerebral/meningeal enhancement, micro hemorrhage, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyper intensities) were assessed from structural magnetic resonance imaging (MRI). Participants with brain abnormality other than those listed above assessed using MRI scan were reported under 'other' category. Only those MRI findings in which at least 1 participant had event, were reported.

Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)

时间窗: Baseline up to Month 18

Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI.

Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M

时间窗: Baseline, Month 13

Quantitative amyloid imaging was performed using PET technique using \[11C\] Pittsburgh Compound B (PIB) for following brain areas: frontal, temporal, parietal and occipital cortices, anterior and posterior cingular cortex, cerebellum, pons, and subcortical white matter. For target regions of interest, beta-amyloid plaque imaging radiotracer (PIB) retention data was expressed as standard uptake value ratio (SUVR) which was defined as a ratio of radioactivity uptake of the target region relative to the cerebellum reference region. This outcome measure was planned to be analyzed only for cohort M.

Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0

时间窗: 0 hour on Day 0 (Day prior to dosing)