A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab
2020년 2월 18일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
360
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Berlin, 독일, 12203
- Univ Berlin; Klin fur Psychi & Psycho Charite
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Günzburg, 독일, 89312
- Bezirkskrankenhaus Günzburg
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Mannheim, 독일, 68159
- Zentralinstitut fuer Seelische Gesundheit
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Munchen, 독일, 81377
- Ludwig-Maximilians-Univ.
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Munchen, 독일, 81675
- Klinikum rechts der Isar der Technischen Universität München
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Tubingen, 독일, 72076
- Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
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Arizona
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Phoenix, Arizona, 미국, 85006
- Banner Alzheimer's Institute
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic
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Sun City, Arizona, 미국, 85351
- Banner Sun Health Research Insitute
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California
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Encino, California, 미국, 91316
- Pharmacology Research Inst
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Fresno, California, 미국, 93720
- Margolin Brain Institute
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La Jolla, California, 미국, 92037
- Univ of CA San Diego; Neurosciences Comp.Alzheimer's
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Los Angeles, California, 미국, 90095
- University of California Los Angeles (UCLA)
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Los Angeles, California, 미국, 90033
- USC School of Medicine
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Newport Beach, California, 미국, 92660
- Pharmacology Research Inst
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Oxnard, California, 미국, 93030
- Pacific Neuroscience Med Grp
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Palo Alto, California, 미국, 94304
- Stanford Univ Medical Center
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Sacramento, California, 미국, 95817
- University of California Davis Medical System
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San Diego, California, 미국, 92103
- Pacific Research Network - PRN
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San Francisco, California, 미국, 94117
- Uni of California San Francisco
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Santa Rosa, California, 미국, 95403
- Redwood Regional Medical Group
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Connecticut
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New Haven, Connecticut, 미국, 06511
- Yale University
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Florida
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Boca Raton, Florida, 미국, 33431
- Florida Atlantic University; College of Medicine
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Brooksville, Florida, 미국, 34601
- Meridien Research
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Delray Beach, Florida, 미국, 33445
- Brain Matters Research, Inc.
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Miami, Florida, 미국, 33137
- Miami Jewish Health Systems; Clinical Research
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Naples, Florida, 미국, 34105
- Collier Neurologic Specialists
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Orlando, Florida, 미국, 32806
- Bioclinica Research
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Tampa, Florida, 미국, 33609
- Axiom Clinical Research of Florida
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West Palm Beach, Florida, 미국, 33407
- Premiere Research Institute
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Georgia
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Decatur, Georgia, 미국, 30033
- DeKalb Neurology Associates
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Illinois
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Chicago, Illinois, 미국, 60612
- Rush Alzheimer's Disease Cntr.
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Elk Grove Village, Illinois, 미국, 60007
- Alexian Brothers Neurosci Inst
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana Univ School of Med
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Louisiana
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New Orleans, Louisiana, 미국, 70114
- Louisiana Research Associates
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Mississippi
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Hattiesburg, Mississippi, 미국, 39401
- Hattiesburg Clinic
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Missouri
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Saint Louis, Missouri, 미국, 63132
- Millennium Psychiatric Associates, LLC
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Nevada
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Las Vegas, Nevada, 미국, 89106
- Cleveland Clinic Lou Ruvo; Center for Brain Research
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New Jersey
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Eatontown, New Jersey, 미국, 07724
- Memory Enhancement Center of America, Inc.
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Mount Arlington, New Jersey, 미국, 07856
- NeuroCognitive Institute
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New York
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Latham, New York, 미국, 12210
- Empire Neurology, PC
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Manhasset, New York, 미국, 11030
- Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
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New York, New York, 미국, 10032
- Columbia University Medical Center
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Rochester, New York, 미국, 14627
- University of Rochester Medical Center; Monroe Community Hospital
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Rochester, New York, 미국, 14642
- Investigational Drug Service; Univ of Rochester Medical Ctr
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North Carolina
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Raleigh, North Carolina, 미국, 27607-6520
- Raleigh Neurology Associates
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Oregon
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Portland, Oregon, 미국, 97210
- Summit Research Network Inc.
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Pennsylvania
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Jenkintown, Pennsylvania, 미국, 19046
- The Clinical Trial Center, LLC
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Rhode Island
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East Providence, Rhode Island, 미국, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, 미국, 02906
- Butler Hospital
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South Carolina
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North Charleston, South Carolina, 미국, 29425
- Medical Uni of South Carolina
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Texas
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Houston, Texas, 미국, 77030
- Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
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Vermont
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Bennington, Vermont, 미국, 05201
- Clinical Neuroscience Research Associates, Inc.
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Albacete, 스페인, 2006
- Complejo Hospitalario Universitario de Albacete
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Madrid, 스페인, 28006
- Clinica Ruber, 4 planta; Servicio de Neurologia
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Barcelona
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BArcelon, Barcelona, 스페인, 08034
- Fundació ACE
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San Cugat Del Valles, Barcelona, 스페인, 08195
- Hospital General de Catalunya
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Guipuzcoa
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San Sebastian, Guipuzcoa, 스페인, 20009
- Policlinica Guipuzcoa
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Vizcaya
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Barakaldo, Vizcaya, 스페인, 48903
- Hospital de Cruces; Servicio de Neurologia
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Bath, 영국, BA1 3NG
- The Rice Centre; Royal United Hospital
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Brentford, 영국, TW8 8DS
- West London Research Unit; Brentford Lodge
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Brighton, 영국, BN2 5BE
- Royal Sussex County Hospital, CIRU Level 5
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Glasgow, 영국, G20 0XA
- Glasgow Memory Clinic
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London, GT LON, 영국, WC1N 3BG
- The National Hospital for Neurology & Neurosurgery; Dementia Research Center
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Southampton, 영국, SO30 3JB
- Moorgreen Hospital; Memory Assessment & Rsch Ctr
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Southampton, 영국, SO16 6YD
- Southampton General Hospital; Pharmacy
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Swindon, 영국, SN3 6BW
- Great Western Hosp.; Kingshill Research Ctr
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British Columbia
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Kelowna, British Columbia, 캐나다, V1Y 3G8
- The Med Arts Health Rsrch Grp
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Vancouver, British Columbia, 캐나다, V6T 2B5
- University of British Columbia Hospital; Division of Neurology
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Nova Scotia
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Halilfax, Nova Scotia, 캐나다, B3H 2E1
- Capitol District Health Authority
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Ontario
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Burlington, Ontario, 캐나다, L7M 4Y1
- JBN Medical Diagnostic Services Inc.
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Kingston, Ontario, 캐나다, K7L 2V7
- Hôtel Dieu Hospital
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London, Ontario, 캐나다, N6C 5J1
- St. Joseph's HC-Parkwood Hosp
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Ottawa, Ontario, 캐나다, K1N 5C8
- Bruyere Continuing Care
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Peterborough, Ontario, 캐나다, K9H 2P4
- Kawartha Centre - Redefining Healthy Aging
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Toronto, Ontario, 캐나다, M3B 2S7
- Toronto Memory Program (Neurology Research Inc.)
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Quebec
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Greenfield Park, Quebec, 캐나다, J4V 2J2
- Clinique Neuro Rive-Sud
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Montreal, Quebec, 캐나다, H1T 2M4
- Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
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Quebec City, Quebec, 캐나다, G1J 1Z4
- CHAUQ Hopital Enfant-Jesus
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Verdun, Quebec, 캐나다, H4H 1R3
- McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
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Bron, 프랑스, 69677
- Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
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Limoges, 프랑스, 87042
- CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
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Nancy, 프랑스, 54035
- Hopital Central; Neurologie
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Nantes, 프랑스, 44093
- Hôpital Nord Laennec
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Rouen, 프랑스, 76031
- CHU de Rouen Hopital; Service de Neurologie
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Strasbourg, 프랑스, 67091
- Hôpital civil de Strasbourg
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
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Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants With Adverse Events (AEs)
기간: Up to 50 months
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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.
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Up to 50 months
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Percentage of Participants by Nature of AEs
기간: Up to 50 months
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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.
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Up to 50 months
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Percentage of Participants by Severity of AEs
기간: Up to 50 months
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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.
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Up to 50 months
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Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation
기간: Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)
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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.
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Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)
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Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)
기간: Baseline, Weeks 23, 47, 71, 97, 121 and 153
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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.
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Baseline, Weeks 23, 47, 71, 97, 121 and 153
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Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)
기간: Baseline, Weeks 23, 47, 71, 97, 121 and 153
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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.
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Baseline, Weeks 23, 47, 71, 97, 121 and 153
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2012년 12월 7일
기본 완료 (실제)
2017년 2월 8일
연구 완료 (실제)
2017년 2월 8일
연구 등록 날짜
최초 제출
2012년 11월 6일
QC 기준을 충족하는 최초 제출
2012년 11월 6일
처음 게시됨 (추정)
2012년 11월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 2월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 2월 18일
마지막으로 확인됨
2020년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .