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A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab

2020年2月18日 更新者：Genentech, Inc.

A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients With Mild to Moderate Alzheimer's Disease

This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's disease who have participated in and completed the treatment period of the Phase II Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on study treatment is 144 weeks.

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)

360

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
      • Phoenix、Arizona、アメリカ、85006
        • Banner Alzheimer's Institute
      • Scottsdale、Arizona、アメリカ、85259
        • Mayo Clinic
      • Sun City、Arizona、アメリカ、85351
        • Banner Sun Health Research Insitute
    • California
      • Encino、California、アメリカ、91316
        • Pharmacology Research Inst
      • Fresno、California、アメリカ、93720
        • Margolin Brain Institute
      • La Jolla、California、アメリカ、92037
        • Univ of CA San Diego; Neurosciences Comp.Alzheimer's
      • Los Angeles、California、アメリカ、90095
        • University of California Los Angeles (UCLA)
      • Los Angeles、California、アメリカ、90033
        • USC School of Medicine
      • Newport Beach、California、アメリカ、92660
        • Pharmacology Research Inst
      • Oxnard、California、アメリカ、93030
        • Pacific Neuroscience Med Grp
      • Palo Alto、California、アメリカ、94304
        • Stanford Univ Medical Center
      • Sacramento、California、アメリカ、95817
        • University of California Davis Medical System
      • San Diego、California、アメリカ、92103
        • Pacific Research Network - PRN
      • San Francisco、California、アメリカ、94117
        • Uni of California San Francisco
      • Santa Rosa、California、アメリカ、95403
        • Redwood Regional Medical Group
    • Connecticut
      • New Haven、Connecticut、アメリカ、06511
        • Yale University
    • Florida
      • Boca Raton、Florida、アメリカ、33431
        • Florida Atlantic University; College of Medicine
      • Brooksville、Florida、アメリカ、34601
        • Meridien Research
      • Delray Beach、Florida、アメリカ、33445
        • Brain Matters Research, Inc.
      • Miami、Florida、アメリカ、33137
        • Miami Jewish Health Systems; Clinical Research
      • Naples、Florida、アメリカ、34105
        • Collier Neurologic Specialists
      • Orlando、Florida、アメリカ、32806
        • Bioclinica Research
      • Tampa、Florida、アメリカ、33609
        • Axiom Clinical Research of Florida
      • West Palm Beach、Florida、アメリカ、33407
        • Premiere Research Institute
    • Georgia
      • Decatur、Georgia、アメリカ、30033
        • DeKalb Neurology Associates
    • Illinois
      • Chicago、Illinois、アメリカ、60612
        • Rush Alzheimer's Disease Cntr.
      • Elk Grove Village、Illinois、アメリカ、60007
        • Alexian Brothers Neurosci Inst
    • Indiana
      • Indianapolis、Indiana、アメリカ、46202
        • Indiana Univ School of Med
    • Louisiana
      • New Orleans、Louisiana、アメリカ、70114
        • Louisiana Research Associates
    • Mississippi
      • Hattiesburg、Mississippi、アメリカ、39401
        • Hattiesburg Clinic
    • Missouri
      • Saint Louis、Missouri、アメリカ、63132
        • Millennium Psychiatric Associates, LLC
    • Nevada
      • Las Vegas、Nevada、アメリカ、89106
        • Cleveland Clinic Lou Ruvo; Center for Brain Research
    • New Jersey
      • Eatontown、New Jersey、アメリカ、07724
        • Memory Enhancement Center of America, Inc.
      • Mount Arlington、New Jersey、アメリカ、07856
        • NeuroCognitive Institute
    • New York
      • Latham、New York、アメリカ、12210
        • Empire Neurology, PC
      • Manhasset、New York、アメリカ、11030
        • Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
      • New York、New York、アメリカ、10032
        • Columbia University Medical Center
      • Rochester、New York、アメリカ、14627
        • University of Rochester Medical Center; Monroe Community Hospital
      • Rochester、New York、アメリカ、14642
        • Investigational Drug Service; Univ of Rochester Medical Ctr
    • North Carolina
      • Raleigh、North Carolina、アメリカ、27607-6520
        • Raleigh Neurology Associates
    • Oregon
      • Portland、Oregon、アメリカ、97210
        • Summit Research Network Inc.
    • Pennsylvania
      • Jenkintown、Pennsylvania、アメリカ、19046
        • The Clinical Trial Center, LLC
    • Rhode Island
      • East Providence、Rhode Island、アメリカ、02914
        • Rhode Island Mood & Memory Research Institute
      • Providence、Rhode Island、アメリカ、02906
        • Butler Hospital
    • South Carolina
      • North Charleston、South Carolina、アメリカ、29425
        • Medical Uni of South Carolina
    • Texas
      • Houston、Texas、アメリカ、77030
        • Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
    • Vermont
      • Bennington、Vermont、アメリカ、05201
        • Clinical Neuroscience Research Associates, Inc.
  • イギリス
      • Bath、イギリス、BA1 3NG
        • The Rice Centre; Royal United Hospital
      • Brentford、イギリス、TW8 8DS
        • West London Research Unit; Brentford Lodge
      • Brighton、イギリス、BN2 5BE
        • Royal Sussex County Hospital, CIRU Level 5
      • Glasgow、イギリス、G20 0XA
        • Glasgow Memory Clinic
      • London, GT LON、イギリス、WC1N 3BG
        • The National Hospital for Neurology & Neurosurgery; Dementia Research Center
      • Southampton、イギリス、SO30 3JB
        • Moorgreen Hospital; Memory Assessment & Rsch Ctr
      • Southampton、イギリス、SO16 6YD
        • Southampton General Hospital; Pharmacy
      • Swindon、イギリス、SN3 6BW
        • Great Western Hosp.; Kingshill Research Ctr
  • カナダ
    • British Columbia
      • Kelowna、British Columbia、カナダ、V1Y 3G8
        • The Med Arts Health Rsrch Grp
      • Vancouver、British Columbia、カナダ、V6T 2B5
        • University of British Columbia Hospital; Division of Neurology
    • Nova Scotia
      • Halilfax、Nova Scotia、カナダ、B3H 2E1
        • Capitol District Health Authority
    • Ontario
      • Burlington、Ontario、カナダ、L7M 4Y1
        • JBN Medical Diagnostic Services Inc.
      • Kingston、Ontario、カナダ、K7L 2V7
        • Hotel Dieu Hospital
      • London、Ontario、カナダ、N6C 5J1
        • St. Joseph's HC-Parkwood Hosp
      • Ottawa、Ontario、カナダ、K1N 5C8
        • Bruyere Continuing Care
      • Peterborough、Ontario、カナダ、K9H 2P4
        • Kawartha Centre - Redefining Healthy Aging
      • Toronto、Ontario、カナダ、M3B 2S7
        • Toronto Memory Program (Neurology Research Inc.)
    • Quebec
      • Greenfield Park、Quebec、カナダ、J4V 2J2
        • Clinique Neuro Rive-Sud
      • Montreal、Quebec、カナダ、H1T 2M4
        • Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
      • Quebec City、Quebec、カナダ、G1J 1Z4
        • CHAUQ Hopital Enfant-Jesus
      • Verdun、Quebec、カナダ、H4H 1R3
        • McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
  • スペイン
      • Albacete、スペイン、2006
        • Complejo Hospitalario Universitario de Albacete
      • Madrid、スペイン、28006
        • Clinica Ruber, 4 planta; Servicio de Neurologia
    • Barcelona
      • BArcelon、Barcelona、スペイン、08034
        • Fundació ACE
      • San Cugat Del Valles、Barcelona、スペイン、08195
        • Hospital General De Catalunya
    • Guipuzcoa
      • San Sebastian、Guipuzcoa、スペイン、20009
        • Policlínica Guipuzcoa
    • Vizcaya
      • Barakaldo、Vizcaya、スペイン、48903
        • Hospital de Cruces; Servicio de Neurologia
  • ドイツ
      • Berlin、ドイツ、12203
        • Univ Berlin; Klin fur Psychi & Psycho Charite
      • Günzburg、ドイツ、89312
        • Bezirkskrankenhaus Günzburg
      • Mannheim、ドイツ、68159
        • Zentralinstitut fuer Seelische Gesundheit
      • Munchen、ドイツ、81377
        • Ludwig-Maximilians-Univ.
      • Munchen、ドイツ、81675
        • Klinikum rechts der Isar der Technischen Universität München
      • Tubingen、ドイツ、72076
        • Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
  • フランス
      • Bron、フランス、69677
        • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
      • Limoges、フランス、87042
        • CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
      • Nancy、フランス、54035
        • Hopital Central; Neurologie
      • Nantes、フランス、44093
        • Hôpital Nord Laennec
      • Rouen、フランス、76031
        • CHU de Rouen Hopital; Service de Neurologie
      • Strasbourg、フランス、67091
        • Hôpital Civil de Strasbourg

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:

  • Previous participation in Study ABE4869g or ABE4955g and completion of the Week 73 visit
  • Adequate visual and auditory acuity, in the investigator's judgment, to allow for neuropsychological testing
  • Availability of a person ("caregiver") who can provide information on activities of daily living and behavior in order to complete the study-specific assessments
  • Diagnosis of probable Alzheimer's disease according to the National Institute on Neurological and Communication Disease and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (McKhann et al. 1984)
  • Mini-Mental State Examination (MMSE) score of 10 or more at screening (Folstein et al. 1975)
  • For male participants with partners with reproductive potential, agreement to use a reliable means of contraception (e.g., condoms) during the study and for at least 8 weeks following the last dose of study drug
  • For female participants, a negative pregnancy test at screening

Exclusion Criteria:

  • Early treatment and/or study discontinuation prior to completion of the Week 73 visit of Genentech Study ABE4869g or ABE4955g
  • Early discontinuation from the treatment schedule of a prior version of Study GN28525 for safety reasons. If treatment discontinuation occurred for safety reasons, participants may not re-start dosing on extended treatment schedules offered in amendments to Study GN28525
  • Inability to tolerate Magnetic Resonance Imaging (MRI) procedures or contraindication to MRI
  • Female participants with reproductive potential: Female participants must either have undergone documented surgical sterilization or have not experienced menstruation for at least 12 consecutive months
  • Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the participant's ability to complete the study assessments or would require the equivalent of institutional or hospital care
  • History or presence of clinically evident vascular disease potentially affecting the brain
  • History of severe, clinically significant central nervous system trauma
  • History or presence of clinically relevant intracranial tumor
  • Presence of infections that affect the brain function or history of infections that resulted in neurologic sequelae
  • History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease
  • History or presence of a neurologic disease other than Alzheimer's disease that may affect cognition
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
  • Evidence of malignancies (except squamous cell cancer or basal cell cancer of the skin), acute infections, renal failure that requires dialysis, or other unstable medical disease not related to Alzheimer's disease that, in the investigator's opinion, would preclude participant's participation. Cancer that is not being actively treated with anti-cancer therapy or radiotherapy as well as cancers which are considered to have low probability of recurrence are allowed
  • History or presence of atrial fibrillation that, in the investigator's judgment, poses a risk for future stroke
  • Chronic kidney disease of Stage greater than or equal to (>=) 4, according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI) guidelines for chronic kidney disease (CKD)
  • Impaired hepatic function
  • Impaired coagulation (activated partial thromboplastin time [aPTT] greater than [>] 1.2 times upper limit of normal [ULN])
  • Platelet count less than (<) 100,000 per microliter (mcL)
  • Presence at screening of superficial siderosis of central nervous system, more than 8 cerebral microhemorrhages, or evidence of a prior cerebral macrohemorrhage
  • Presence at screening of any other significant cerebral abnormalities, including ARIA-E
  • Treatment with anticoagulation medications within 2 weeks prior to enrollment. Clopidogrel, dipyridamole, and aspirin are permitted
  • Treatment with anticholinergic antidepressants, typical antipsychotics, or barbiturates within 2 weeks prior to enrollment. All other antidepressants and atypical antipsychotics are allowed with certain restrictions as defined in the protocol
  • Chronic use of opiates, opioids, or benzodiazepines
  • Any biologic therapy within 75 weeks prior to enrollment
  • Any investigational agent (other than crenezumab) within 75 weeks prior to enrollment
  • Treatment with anticholinergic antidepressants, typical antipsychotics, barbiturates, or narcotics within 5 half-lives or 3 months prior to screening, whichever is longer. All other antidepressants and atypical antipsychotics are allowed. Chronic use of benzodiazepines is not allowed; however, the intermittent use of benzodiazepines is allowed, except within 2 days prior to any neurocognitive assessment

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：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
薬：Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
他の名前：
  • RO5490245

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
Percentage of Participants With Adverse Events (AEs)
時間枠：Up to 50 months
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. . An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Up to 50 months
Percentage of Participants by Nature of AEs
時間枠：Up to 50 months
A serious adverse event (SAE) is any AE that meets any of the following criteria: fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in a neonate/infant. Non-SAE of special interest for this study include the following: cerebral vascular edema, Superficial siderosis of central nervous system, cerebral micro-hemorrhages or macro-hemorrhages, pneumonia, liver injury.
Up to 50 months
Percentage of Participants by Severity of AEs
時間枠：Up to 50 months
AE severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 was used for assessing adverse event severity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1) mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2) moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3) severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4) life-threatening consequences; urgent intervention indicated, Grade 5) death related to AE.
Up to 50 months
Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation
時間枠：Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)
ATA is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy. Percentage of participants at post-baseline with positive results for ATA against crenezumab are reported.
Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)
Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)
時間枠：Baseline, Weeks 23, 47, 71, 97, 121 and 153
Alzheimer's disease (AD) is associated with ARIA. The occurrence of imaging abnormalities believed to represent cerebral vasogenic edema, has been reported in association with the investigational use of compounds that are intended to treat Alzheimer's disease by reducing Abeta in the brain. Here, the percentage of participants with symptomatic and asymptomatic ARIA-E were reported.
Baseline, Weeks 23, 47, 71, 97, 121 and 153
Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)
時間枠：Baseline, Weeks 23, 47, 71, 97, 121 and 153
AD is associated with ARIA. Cerebral micro-hemorrhages (microbleeds [MBs]) are radiologically defined as small dot-like foci of signal loss observed on magnetic resonance imaging (MRI) sequences sensitive for paramagnetic tissue properties. The occurrence of MBs has also been identified as an adverse event in anti-amyloid vaccination trials, and together with superficial siderosis, they have been termed ARIA-H.
Baseline, Weeks 23, 47, 71, 97, 121 and 153

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

Genentech, Inc.

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)

2012年12月7日

一次修了 (実際)

2017年2月8日

研究の完了 (実際)

2017年2月8日

試験登録日

最初に提出

2012年11月6日

QC基準を満たした最初の提出物

2012年11月6日

最初の投稿 (見積もり)

2012年11月8日

学習記録の更新

投稿された最後の更新 (実際)

2020年2月20日

QC基準を満たした最後の更新が送信されました

2020年2月18日

最終確認日

2020年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • GN28525
  • 2012-003242-33 (EudraCT番号)

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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。

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