A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab
18. února 2020 aktualizováno: 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.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
360
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Bron, Francie, 69677
- Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
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Limoges, Francie, 87042
- CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
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Nancy, Francie, 54035
- Hopital Central; Neurologie
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Nantes, Francie, 44093
- Hopital Nord Laennec
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Rouen, Francie, 76031
- CHU de Rouen Hopital; Service de Neurologie
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Strasbourg, Francie, 67091
- Hôpital Civil de Strasbourg
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British Columbia
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Kelowna, British Columbia, Kanada, V1Y 3G8
- The Med Arts Health Rsrch Grp
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Vancouver, British Columbia, Kanada, V6T 2B5
- University of British Columbia Hospital; Division of Neurology
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Nova Scotia
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Halilfax, Nova Scotia, Kanada, B3H 2E1
- Capitol District Health Authority
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Ontario
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Burlington, Ontario, Kanada, L7M 4Y1
- JBN Medical Diagnostic Services Inc.
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Kingston, Ontario, Kanada, K7L 2V7
- Hotel Dieu Hospital
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London, Ontario, Kanada, N6C 5J1
- St. Joseph's HC-Parkwood Hosp
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Ottawa, Ontario, Kanada, K1N 5C8
- Bruyère Continuing Care
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Peterborough, Ontario, Kanada, K9H 2P4
- Kawartha Centre - Redefining Healthy Aging
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Toronto, Ontario, Kanada, M3B 2S7
- Toronto Memory Program (Neurology Research Inc.)
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Quebec
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Greenfield Park, Quebec, Kanada, J4V 2J2
- Clinique Neuro Rive-Sud
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Montreal, Quebec, Kanada, H1T 2M4
- Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
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Quebec City, Quebec, Kanada, G1J 1Z4
- CHAUQ Hopital Enfant-Jesus
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Verdun, Quebec, Kanada, H4H 1R3
- McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
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Berlin, Německo, 12203
- Univ Berlin; Klin fur Psychi & Psycho Charite
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Günzburg, Německo, 89312
- Bezirkskrankenhaus Günzburg
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Mannheim, Německo, 68159
- Zentralinstitut fuer Seelische Gesundheit
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Munchen, Německo, 81377
- Ludwig-Maximilians-Univ.
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Munchen, Německo, 81675
- Klinikum rechts der Isar der Technischen Universität München
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Tubingen, Německo, 72076
- Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
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Bath, Spojené království, BA1 3NG
- The Rice Centre; Royal United Hospital
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Brentford, Spojené království, TW8 8DS
- West London Research Unit; Brentford Lodge
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Brighton, Spojené království, BN2 5BE
- Royal Sussex County Hospital, CIRU Level 5
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Glasgow, Spojené království, G20 0XA
- Glasgow Memory Clinic
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London, GT LON, Spojené království, WC1N 3BG
- The National Hospital for Neurology & Neurosurgery; Dementia Research Center
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Southampton, Spojené království, SO30 3JB
- Moorgreen Hospital; Memory Assessment & Rsch Ctr
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Southampton, Spojené království, SO16 6YD
- Southampton General Hospital; Pharmacy
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Swindon, Spojené království, SN3 6BW
- Great Western Hosp.; Kingshill Research Ctr
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Arizona
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Phoenix, Arizona, Spojené státy, 85006
- Banner Alzheimer's Institute
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Scottsdale, Arizona, Spojené státy, 85259
- Mayo Clinic
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Sun City, Arizona, Spojené státy, 85351
- Banner Sun Health Research Insitute
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California
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Encino, California, Spojené státy, 91316
- Pharmacology Research Inst
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Fresno, California, Spojené státy, 93720
- Margolin Brain Institute
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La Jolla, California, Spojené státy, 92037
- Univ of CA San Diego; Neurosciences Comp.Alzheimer's
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Los Angeles, California, Spojené státy, 90095
- University of California Los Angeles (UCLA)
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Los Angeles, California, Spojené státy, 90033
- USC School of Medicine
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Newport Beach, California, Spojené státy, 92660
- Pharmacology Research Inst
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Oxnard, California, Spojené státy, 93030
- Pacific Neuroscience Med Grp
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Palo Alto, California, Spojené státy, 94304
- Stanford Univ Medical Center
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Sacramento, California, Spojené státy, 95817
- University of California Davis Medical System
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San Diego, California, Spojené státy, 92103
- Pacific Research Network - PRN
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San Francisco, California, Spojené státy, 94117
- Uni of California San Francisco
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Santa Rosa, California, Spojené státy, 95403
- Redwood Regional Medical Group
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Connecticut
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New Haven, Connecticut, Spojené státy, 06511
- Yale University
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Florida
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Boca Raton, Florida, Spojené státy, 33431
- Florida Atlantic University; College of Medicine
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Brooksville, Florida, Spojené státy, 34601
- Meridien Research
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Delray Beach, Florida, Spojené státy, 33445
- Brain Matters Research, Inc.
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Miami, Florida, Spojené státy, 33137
- Miami Jewish Health Systems; Clinical Research
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Naples, Florida, Spojené státy, 34105
- Collier Neurologic Specialists
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Orlando, Florida, Spojené státy, 32806
- Bioclinica Research
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Tampa, Florida, Spojené státy, 33609
- Axiom Clinical Research of Florida
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West Palm Beach, Florida, Spojené státy, 33407
- Premiere Research Institute
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Georgia
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Decatur, Georgia, Spojené státy, 30033
- DeKalb Neurology Associates
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- Rush Alzheimer's Disease Cntr.
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Elk Grove Village, Illinois, Spojené státy, 60007
- Alexian Brothers Neurosci Inst
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202
- Indiana Univ School of Med
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Louisiana
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New Orleans, Louisiana, Spojené státy, 70114
- Louisiana Research Associates
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Mississippi
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Hattiesburg, Mississippi, Spojené státy, 39401
- Hattiesburg Clinic
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Missouri
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Saint Louis, Missouri, Spojené státy, 63132
- Millennium Psychiatric Associates, LLC
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Nevada
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Las Vegas, Nevada, Spojené státy, 89106
- Cleveland Clinic Lou Ruvo; Center for Brain Research
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New Jersey
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Eatontown, New Jersey, Spojené státy, 07724
- Memory Enhancement Center of America, Inc.
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Mount Arlington, New Jersey, Spojené státy, 07856
- NeuroCognitive Institute
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New York
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Latham, New York, Spojené státy, 12210
- Empire Neurology, PC
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Manhasset, New York, Spojené státy, 11030
- Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
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New York, New York, Spojené státy, 10032
- Columbia University Medical Center
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Rochester, New York, Spojené státy, 14627
- University of Rochester Medical Center; Monroe Community Hospital
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Rochester, New York, Spojené státy, 14642
- Investigational Drug Service; Univ of Rochester Medical Ctr
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North Carolina
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Raleigh, North Carolina, Spojené státy, 27607-6520
- Raleigh Neurology Associates
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Oregon
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Portland, Oregon, Spojené státy, 97210
- Summit Research Network Inc.
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Pennsylvania
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Jenkintown, Pennsylvania, Spojené státy, 19046
- The Clinical Trial Center, LLC
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Rhode Island
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East Providence, Rhode Island, Spojené státy, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, Spojené státy, 02906
- Butler Hospital
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South Carolina
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North Charleston, South Carolina, Spojené státy, 29425
- Medical Uni of South Carolina
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Texas
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Houston, Texas, Spojené státy, 77030
- Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
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Vermont
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Bennington, Vermont, Spojené státy, 05201
- Clinical Neuroscience Research Associates, Inc.
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Albacete, Španělsko, 2006
- Complejo Hospitalario Universitario de Albacete
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Madrid, Španělsko, 28006
- Clinica Ruber, 4 planta; Servicio de Neurologia
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Barcelona
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BArcelon, Barcelona, Španělsko, 08034
- Fundació ACE
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San Cugat Del Valles, Barcelona, Španělsko, 08195
- Hospital General de Catalunya
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Guipuzcoa
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San Sebastian, Guipuzcoa, Španělsko, 20009
- Policlinica Guipuzcoa
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Vizcaya
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Barakaldo, Vizcaya, Španělsko, 48903
- Hospital de Cruces; Servicio de Neurologia
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
50 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
|
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
7. prosince 2012
Primární dokončení (Aktuální)
8. února 2017
Dokončení studie (Aktuální)
8. února 2017
Termíny zápisu do studia
První předloženo
6. listopadu 2012
První předloženo, které splnilo kritéria kontroly kvality
6. listopadu 2012
První zveřejněno (Odhad)
8. listopadu 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. února 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. února 2020
Naposledy ověřeno
1. února 2020
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- GN28525
- 2012-003242-33 (Číslo EudraCT)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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