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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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

198

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
薬：Placebo
Placebo every 60 days (10 doses total)
実験的：PF-04360365 8.5 mg/kg
生物学的：PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)
実験的：PF-04360365 1 mg/kg
生物学的：PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
実験的：PF-04360365 3 mg/kg
生物学的：PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
実験的：PF-04360365 0.1 mg/kg
生物学的：PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
実験的：PF-04360365 0.5 mg/kg
生物学的：PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 570
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 570
Mean Plasma Concentration of PF-04360365 on Day 660
時間枠：Day 660
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 660
Mean Plasma Concentration of PF-04360365 on Day 720
時間枠：Day 720
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 720

二次結果の測定

結果測定
メジャーの説明
時間枠
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
時間枠：Day 0 (Hour 0), 90, 570
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pfizer

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2008年12月5日

一次修了 (実際)

2011年8月16日

研究の完了 (実際)

2011年8月16日

試験登録日

最初に提出

2008年7月23日

QC基準を満たした最初の提出物

2008年7月24日

最初の投稿 (見積もり)

2008年7月25日

学習記録の更新

投稿された最後の更新 (実際)

2022年11月7日

QC基準を満たした最後の更新が送信されました

2022年10月11日

最終確認日

2022年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • A9951002
  • 2008-000986-42 (EudraCT番号)
  • MD IN AD PATIENT (その他の識別子：Alias Study Number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

アルツハイマー病の臨床試験

  • Adelphi Values LLC
    Blueprint Medicines Corporation
    完了
    全身性肥満細胞症の患者報告アウトカムアンケート
    肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されました
    アメリカ

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