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Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease

2022年10月11日 更新者：Pfizer

A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE DOSES OF PF 04360365 IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE.

Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

198

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大、V6T 2B5
        • University of British Columbia Hospital, Division of Neurology
    • Ontario
      • London、Ontario、加拿大、N6C 5J1
        • Parkwood Hospital, Geriatric Medicine
      • Peterborough、Ontario、加拿大、K9H 2P4
        • Kawartha Regional Memory Clinic
      • Toronto、Ontario、加拿大、M4N 3M5
        • SunnyBrook Health Sciences Centre
      • Toronto、Ontario、加拿大、M3B 2S7
        • Toronto Memory Program
    • Quebec
      • Montreal、Quebec、加拿大、H1T 2M4
        • Recherche Clinique de Neurologie
      • Sherbrooke、Quebec、加拿大、J1H 1Z1
        • Diex Recherche Inc.
  • 大韩民国
      • Seoul、大韩民国、135-710
        • Samsung Medical Center
      • Seoul、大韩民国、138-736
        • Asan Medical Center
      • Seoul、大韩民国、136-705
        • Korea University Anam Hospital
      • Seoul、大韩民国、133-792
        • Hanyang University Hospital
      • Seoul、大韩民国、143-914
        • Konkuk University Medical Center
    • Gyeonggi
      • Seongnam、Gyeonggi、大韩民国、463-707
        • Seoul National University Bundang Hospital
  • 比利时
      • Antwerpen、比利时、2020
        • ZNA Middelheim / Neurology
      • Edegem、比利时、2650
        • UZ Antwerpen, Department of Neurology
      • Jette、比利时、1090
        • UZ Brussel / Geriatrie
      • Leuven、比利时、3000
        • U.Z. Gasthuisberg / Neurologie
  • 澳大利亚
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • Royal Adelaide Hospital
      • Woodville South、South Australia、澳大利亚、5011
        • The Queen Elizabeth Hospital and Health Service
    • Victoria
      • Heidelberg West、Victoria、澳大利亚、3084
        • Heidelberg Repatriation Hospital, Austin Health
    • Western Australia
      • Nedlands、Western Australia、澳大利亚、6009
        • The McCusker Foundation for Alzheimer's Disease Research
  • 美国
    • Arizona
      • Peoria、Arizona、美国、85381
        • Pivotal Research Center
      • Peoria、Arizona、美国、85381
        • Sun Radiology- for MRI
      • Phoenix、Arizona、美国、85013
        • Dedicated Phase 1
    • Florida
      • Miami、Florida、美国、33176
        • Neuroscience Consultants, LLC
      • South Miami、Florida、美国、33143
        • Miami Research Associates
      • South Miami、Florida、美国、33143
        • MRA Clinical Research
      • South Miami、Florida、美国、33143
        • Sleep Florida, LLC
    • Illinois
      • Elk Grove Village、Illinois、美国、60007
        • Alexian Brothers Medical Center
      • Elk Grove Village、Illinois、美国、60007
        • Alexian Brothers Neurosciences Institute
    • Kansas
      • Overland Park、Kansas、美国、66212
        • Vince and Associates Clinical Research
      • Overland Park、Kansas、美国、66209
        • Stark Pharmacy
      • Overland Park、Kansas、美国、66211
        • Vince and Associates Clinical Research
    • New Jersey
      • Eatontown、New Jersey、美国、07724
        • Memory Enhancement Center of America, Inc
      • Oakhurst、New Jersey、美国、07755
        • Central Jersey Radiology
    • Rhode Island
      • Providence、Rhode Island、美国、02906
        • Butler Hospital
  • 英国
      • Manchester、英国、M50 2GY
        • MAC UK Neuroscience Ltd
      • Southampton、英国、SO30 3JB
        • Memory Assessment and Research Centre
      • Southampton、英国、SO16 6YD
        • Wellcome Trust Clinical Research Facility
    • Chesire
      • Cheadle、Chesire、英国、SK8 2PX
        • The Pharmacy Department
    • Wiltshire
      • Swindon、Wiltshire、英国、SN3 6BB
        • The Shalbourne Suite
      • Swindon、Wiltshire、英国、SN3 6BW
        • Kingshill Research Centre

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Males or females of non childbearing potential, age > or = 50

  • Diagnosis of probable Alzheimer's disease, consistent with criterial 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：Placebo
Placebo every 60 days (10 doses total)
实验性的：PF-04360365 8.5 mg/kg
生物：PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)
实验性的：PF-04360365 1 mg/kg
生物：PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
实验性的：PF-04360365 3 mg/kg
生物：PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
实验性的：PF-04360365 0.1 mg/kg
生物：PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
实验性的：PF-04360365 0.5 mg/kg
生物：PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
大体时间：Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state.
Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
大体时间：Baseline up to Month 24
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline up to Month 24
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
大体时间：Baseline up to Month 24
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. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline up to Month 24
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
大体时间：0 Hour on Day 0
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour on Day 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
大体时间：0 Hour (pre-dose) on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 1
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
大体时间：2 Hours on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 1
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
大体时间：0 Hour (pre-dose) on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 60
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
大体时间：2 Hours on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 60
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
大体时间：Day 90
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 90
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
大体时间：0 Hour (pre-dose) on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 120
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
大体时间：2 Hours on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 120
Mean Plasma Concentration of PF-04360365 on Day 150
大体时间：Day 150
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 150
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
大体时间：0 Hour (pre-dose) on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 180
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
大体时间：2 Hours on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 180
Mean Plasma Concentration of PF-04360365 on Day 210
大体时间：Day 210
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 210
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
大体时间：0 Hour (pre-dose) on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 240
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
大体时间：2 Hours on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 240
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
大体时间：0 Hour (pre-dose) on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 300
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
大体时间：2 Hours on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 300
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
大体时间：0 Hour (pre-dose) on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 360
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
大体时间：2 Hours on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 360
Mean Plasma Concentration of PF-04360365 on Day 390
大体时间：Day 390
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 390
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
大体时间：0 Hour (pre-dose) on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 420
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
大体时间：2 Hours on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 420
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
大体时间：0 Hour (pre-dose) on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 480
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
大体时间：2 Hours on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 480
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
大体时间：0 Hour (pre-dose) on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 540
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
大体时间：2 Hours on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 540
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
大体时间：Day 570
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 570
Mean Plasma Concentration of PF-04360365 on Day 660
大体时间：Day 660
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 660
Mean Plasma Concentration of PF-04360365 on Day 720
大体时间：Day 720
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 720

次要结果测量

结果测量
措施说明
大体时间
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
大体时间：Baseline
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
大体时间：Baseline and Month 19
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline and Month 19
Disability Assessment for Dementia (DAD) Score at Baseline
大体时间：Baseline
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline
Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
大体时间：Baseline and Month 19
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline and Month 19
Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)
大体时间：0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)
大体时间：0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)
大体时间：0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Results are not reported for PF-04360365 0.1, 0.5, 1.0 mg/kg, Placebo (Part A and B) arms because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)
大体时间：Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
大体时间：Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
大体时间：Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
大体时间：Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
大体时间：Baseline up to Month 24
Abnormality was defined as concentration either less than lower limit of normal (LLN) or more than upper limit of normal (ULN). Baseline was defined as the last assessment prior to the first study drug infusion
Baseline up to Month 24
Number of Participants With Serum Anti-Drug Anti Body (ADA)
大体时间：Day 1 up to Month 24
Serum samples were analyzed for the presence or absence of anti-PF-04360365 antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). Only participants receiving PF-04360365 were analyzed for this outcome measure.
Day 1 up to Month 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2008年12月5日

初级完成 (实际的)

2011年8月16日

研究完成 (实际的)

2011年8月16日

研究注册日期

首次提交

2008年7月23日

首先提交符合 QC 标准的

2008年7月24日

首次发布 (估计)

2008年7月25日

研究记录更新

最后更新发布 (实际的)

2022年11月7日

上次提交的符合 QC 标准的更新

2022年10月11日

最后验证

2022年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A9951002
  • 2008-000986-42 (EudraCT编号)
  • MD IN AD PATIENT (其他标识符：Alias Study Number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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