A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab
18 февраля 2020 г. обновлено: 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.
Обзор исследования
Тип исследования
Интервенционный
Регистрация (Действительный)
360
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Berlin, Германия, 12203
- Univ Berlin; Klin fur Psychi & Psycho Charite
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Günzburg, Германия, 89312
- Bezirkskrankenhaus Günzburg
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Mannheim, Германия, 68159
- Zentralinstitut fuer Seelische Gesundheit
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Munchen, Германия, 81377
- Ludwig-Maximilians-Univ.
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Munchen, Германия, 81675
- Klinikum rechts der Isar der Technischen Universitat Munchen
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Tubingen, Германия, 72076
- Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
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Albacete, Испания, 2006
- Complejo Hospitalario Universitario de Albacete
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Madrid, Испания, 28006
- Clinica Ruber, 4 planta; Servicio de Neurologia
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Barcelona
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BArcelon, Barcelona, Испания, 08034
- Fundacio ACE
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San Cugat Del Valles, Barcelona, Испания, 08195
- Hospital General de Catalunya
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Guipuzcoa
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San Sebastian, Guipuzcoa, Испания, 20009
- Policlinica Guipuzcoa
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Vizcaya
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Barakaldo, Vizcaya, Испания, 48903
- Hospital de Cruces; Servicio de Neurologia
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British Columbia
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Kelowna, British Columbia, Канада, V1Y 3G8
- The Med Arts Health Rsrch Grp
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Vancouver, British Columbia, Канада, V6T 2B5
- University of British Columbia Hospital; Division of Neurology
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Nova Scotia
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Halilfax, Nova Scotia, Канада, B3H 2E1
- Capitol District Health Authority
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Ontario
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Burlington, Ontario, Канада, L7M 4Y1
- JBN Medical Diagnostic Services Inc.
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Kingston, Ontario, Канада, K7L 2V7
- Hôtel Dieu Hospital
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London, Ontario, Канада, N6C 5J1
- St. Joseph's HC-Parkwood Hosp
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Ottawa, Ontario, Канада, K1N 5C8
- Bruyere Continuing Care
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Peterborough, Ontario, Канада, K9H 2P4
- Kawartha Centre - Redefining Healthy Aging
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Toronto, Ontario, Канада, M3B 2S7
- Toronto Memory Program (Neurology Research Inc.)
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Quebec
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Greenfield Park, Quebec, Канада, J4V 2J2
- Clinique Neuro Rive-Sud
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Montreal, Quebec, Канада, H1T 2M4
- Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
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Quebec City, Quebec, Канада, G1J 1Z4
- CHAUQ Hopital Enfant-Jesus
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Verdun, Quebec, Канада, H4H 1R3
- McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
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Bath, Соединенное Королевство, BA1 3NG
- The Rice Centre; Royal United Hospital
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Brentford, Соединенное Королевство, TW8 8DS
- West London Research Unit; Brentford Lodge
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Brighton, Соединенное Королевство, BN2 5BE
- Royal Sussex County Hospital, CIRU Level 5
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Glasgow, Соединенное Королевство, G20 0XA
- Glasgow Memory Clinic
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London, GT LON, Соединенное Королевство, WC1N 3BG
- The National Hospital for Neurology & Neurosurgery; Dementia Research Center
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Southampton, Соединенное Королевство, SO30 3JB
- Moorgreen Hospital; Memory Assessment & Rsch Ctr
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Southampton, Соединенное Королевство, SO16 6YD
- Southampton General Hospital; Pharmacy
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Swindon, Соединенное Королевство, SN3 6BW
- Great Western Hosp.; Kingshill Research Ctr
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85006
- Banner Alzheimer's Institute
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Scottsdale, Arizona, Соединенные Штаты, 85259
- Mayo Clinic
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Sun City, Arizona, Соединенные Штаты, 85351
- Banner Sun Health Research Insitute
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California
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Encino, California, Соединенные Штаты, 91316
- Pharmacology Research Inst
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Fresno, California, Соединенные Штаты, 93720
- Margolin Brain Institute
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La Jolla, California, Соединенные Штаты, 92037
- Univ of CA San Diego; Neurosciences Comp.Alzheimer's
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Los Angeles, California, Соединенные Штаты, 90095
- University of California Los Angeles (UCLA)
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Los Angeles, California, Соединенные Штаты, 90033
- USC School of Medicine
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Newport Beach, California, Соединенные Штаты, 92660
- Pharmacology Research Inst
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Oxnard, California, Соединенные Штаты, 93030
- Pacific Neuroscience Med Grp
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Palo Alto, California, Соединенные Штаты, 94304
- Stanford Univ Medical Center
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Sacramento, California, Соединенные Штаты, 95817
- University of California Davis Medical System
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San Diego, California, Соединенные Штаты, 92103
- Pacific Research Network - PRN
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San Francisco, California, Соединенные Штаты, 94117
- Uni of California San Francisco
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Santa Rosa, California, Соединенные Штаты, 95403
- Redwood Regional Medical Group
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Connecticut
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New Haven, Connecticut, Соединенные Штаты, 06511
- Yale University
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Florida
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Boca Raton, Florida, Соединенные Штаты, 33431
- Florida Atlantic University; College of Medicine
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Brooksville, Florida, Соединенные Штаты, 34601
- Meridien Research
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Delray Beach, Florida, Соединенные Штаты, 33445
- Brain Matters Research, Inc.
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Miami, Florida, Соединенные Штаты, 33137
- Miami Jewish Health Systems; Clinical Research
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Naples, Florida, Соединенные Штаты, 34105
- Collier Neurologic Specialists
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Orlando, Florida, Соединенные Штаты, 32806
- Bioclinica Research
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Tampa, Florida, Соединенные Штаты, 33609
- Axiom Clinical Research of Florida
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West Palm Beach, Florida, Соединенные Штаты, 33407
- Premiere Research Institute
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Georgia
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Decatur, Georgia, Соединенные Штаты, 30033
- DeKalb Neurology Associates
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60612
- Rush Alzheimer's Disease Cntr.
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Elk Grove Village, Illinois, Соединенные Штаты, 60007
- Alexian Brothers Neurosci Inst
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Indiana
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Indianapolis, Indiana, Соединенные Штаты, 46202
- Indiana Univ School of Med
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Louisiana
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New Orleans, Louisiana, Соединенные Штаты, 70114
- Louisiana Research Associates
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Mississippi
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Hattiesburg, Mississippi, Соединенные Штаты, 39401
- Hattiesburg Clinic
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Missouri
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Saint Louis, Missouri, Соединенные Штаты, 63132
- Millennium Psychiatric Associates, LLC
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Nevada
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Las Vegas, Nevada, Соединенные Штаты, 89106
- Cleveland Clinic Lou Ruvo; Center for Brain Research
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New Jersey
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Eatontown, New Jersey, Соединенные Штаты, 07724
- Memory Enhancement Center of America, Inc.
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Mount Arlington, New Jersey, Соединенные Штаты, 07856
- NeuroCognitive Institute
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New York
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Latham, New York, Соединенные Штаты, 12210
- Empire Neurology, PC
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Manhasset, New York, Соединенные Штаты, 11030
- Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
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New York, New York, Соединенные Штаты, 10032
- Columbia University Medical Center
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Rochester, New York, Соединенные Штаты, 14627
- University of Rochester Medical Center; Monroe Community Hospital
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Rochester, New York, Соединенные Штаты, 14642
- Investigational Drug Service; Univ of Rochester Medical Ctr
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North Carolina
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Raleigh, North Carolina, Соединенные Штаты, 27607-6520
- Raleigh Neurology Associates
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Oregon
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Portland, Oregon, Соединенные Штаты, 97210
- Summit Research Network Inc.
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Pennsylvania
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Jenkintown, Pennsylvania, Соединенные Штаты, 19046
- The Clinical Trial Center, LLC
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Rhode Island
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East Providence, Rhode Island, Соединенные Штаты, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, Соединенные Штаты, 02906
- Butler Hospital
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South Carolina
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North Charleston, South Carolina, Соединенные Штаты, 29425
- Medical Uni of South Carolina
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Texas
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Houston, Texas, Соединенные Штаты, 77030
- Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
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Vermont
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Bennington, Vermont, Соединенные Штаты, 05201
- Clinical Neuroscience Research Associates, Inc.
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Bron, Франция, 69677
- Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
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Limoges, Франция, 87042
- CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
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Nancy, Франция, 54035
- Hopital Central; Neurologie
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Nantes, Франция, 44093
- Hopital Nord Laennec
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Rouen, Франция, 76031
- CHU de Rouen Hopital; Service de Neurologie
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Strasbourg, Франция, 67091
- Hôpital civil de Strasbourg
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
50 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
Временное ограничение: 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
|
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Percentage of Participants by Nature of AEs
Временное ограничение: 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.
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Up to 50 months
|
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Percentage of Participants by Severity of AEs
Временное ограничение: 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.
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Up to 50 months
|
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Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation
Временное ограничение: 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)
Временное ограничение: 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.
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Baseline, Weeks 23, 47, 71, 97, 121 and 153
|
|
Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)
Временное ограничение: 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.
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Baseline, Weeks 23, 47, 71, 97, 121 and 153
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
7 декабря 2012 г.
Первичное завершение (Действительный)
8 февраля 2017 г.
Завершение исследования (Действительный)
8 февраля 2017 г.
Даты регистрации исследования
Первый отправленный
6 ноября 2012 г.
Впервые представлено, что соответствует критериям контроля качества
6 ноября 2012 г.
Первый опубликованный (Оценивать)
8 ноября 2012 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
20 февраля 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
18 февраля 2020 г.
Последняя проверка
1 февраля 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- GN28525
- 2012-003242-33 (Номер EudraCT)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .