A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab
NCT ID: NCT01723826
Last Updated: 2020-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
360 participants
INTERVENTIONAL
2012-12-07
2017-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Interventions
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Crenezumab
Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Banner Sun Health Research Insitute
Sun City, Arizona, United States
Pharmacology Research Inst
Encino, California, United States
Margolin Brain Institute
Fresno, California, United States
Univ of CA San Diego; Neurosciences Comp.Alzheimer's
La Jolla, California, United States
USC School of Medicine
Los Angeles, California, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
Pharmacology Research Inst
Newport Beach, California, United States
Pacific Neuroscience Med Grp
Oxnard, California, United States
Stanford Univ Medical Center
Palo Alto, California, United States
University of California Davis Medical System
Sacramento, California, United States
Pacific Research Network - PRN
San Diego, California, United States
Uni of California San Francisco
San Francisco, California, United States
Redwood Regional Medical Group
Santa Rosa, California, United States
Yale University
New Haven, Connecticut, United States
Florida Atlantic University; College of Medicine
Boca Raton, Florida, United States
Meridien Research
Brooksville, Florida, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Miami Jewish Health Systems; Clinical Research
Miami, Florida, United States
Collier Neurologic Specialists
Naples, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Dekalb Neurology Associates
Decatur, Georgia, United States
Rush Alzheimer's Disease Cntr.
Chicago, Illinois, United States
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, United States
Indiana Univ School of Med
Indianapolis, Indiana, United States
Louisiana Research Associates
New Orleans, Louisiana, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Millennium Psychiatric Associates, LLC
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
NeuroCognitive Institute
Mount Arlington, New Jersey, United States
Empire Neurology, PC
Latham, New York, United States
Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
Manhasset, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center; Monroe Community Hospital
Rochester, New York, United States
Investigational Drug Service; Univ of Rochester Medical Ctr
Rochester, New York, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Summit Research Network Inc.
Portland, Oregon, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
Medical Uni of South Carolina
North Charleston, South Carolina, United States
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
Houston, Texas, United States
Clinical Neuroscience Research Associates, Inc.
Bennington, Vermont, United States
The Med Arts Health Rsrch Grp
Kelowna, British Columbia, Canada
University of British Columbia Hospital; Division of Neurology
Vancouver, British Columbia, Canada
Capitol District Health Authority
Halilfax, Nova Scotia, Canada
Jbn Medical Diagnostic Services Inc.
Burlington, Ontario, Canada
Hotel Dieu Hospital
Kingston, Ontario, Canada
St. Joseph's HC-Parkwood Hosp
London, Ontario, Canada
Bruyere Continuing Care
Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada
Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
Montreal, Quebec, Canada
CHAUQ Hopital Enfant-Jesus
Québec, Quebec, Canada
McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
Verdun, Quebec, Canada
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, , France
CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
Limoges, , France
Hopital Central; Neurologie
Nancy, , France
Hopital Nord Laennec
Nantes, , France
CHU de Rouen Hopital; Service de Neurologie
Rouen, , France
Hôpital Civil de Strasbourg
Strasbourg, , France
Univ Berlin; Klin fur Psychi & Psycho Charite
Berlin, , Germany
Bezirkskrankenhaus Günzburg
Günzburg, , Germany
Zentralinstitut fuer Seelische Gesundheit
Mannheim, , Germany
Ludwig-Maximilians-Univ.
München, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
Tübingen, , Germany
Fundació ACE
BArcelon, Barcelona, Spain
Hospital General de Catalunya
San Cugat Del Valles, Barcelona, Spain
Policlinica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital de Cruces; Servicio de Neurologia
Barakaldo, Vizcaya, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, , Spain
Clinica Ruber, 4 planta; Servicio de Neurologia
Madrid, , Spain
The Rice Centre; Royal United Hospital
Bath, , United Kingdom
West London Research Unit; Brentford Lodge
Brentford, , United Kingdom
Royal Sussex County Hospital, CIRU Level 5
Brighton, , United Kingdom
Glasgow Memory Clinic
Glasgow, , United Kingdom
The National Hospital for Neurology & Neurosurgery; Dementia Research Center
London, GT LON, , United Kingdom
Southampton General Hospital; Pharmacy
Southampton, , United Kingdom
Moorgreen Hospital; Memory Assessment & Rsch Ctr
Southampton, , United Kingdom
Great Western Hosp.; Kingshill Research Ctr
Swindon, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2012-003242-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GN28525
Identifier Type: -
Identifier Source: org_study_id
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