A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab
tiistai 18. helmikuuta 2020 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
360
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Albacete, Espanja, 2006
- Complejo Hospitalario Universitario de Albacete
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Madrid, Espanja, 28006
- Clinica Ruber, 4 planta; Servicio de Neurologia
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Barcelona
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BArcelon, Barcelona, Espanja, 08034
- Fundació ACE
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San Cugat Del Valles, Barcelona, Espanja, 08195
- Hospital General De Catalunya
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Guipuzcoa
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San Sebastian, Guipuzcoa, Espanja, 20009
- Policlínica Guipuzcoa
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Vizcaya
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Barakaldo, Vizcaya, Espanja, 48903
- Hospital de Cruces; Servicio de Neurologia
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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
- Bruyere 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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Bron, Ranska, 69677
- Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
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Limoges, Ranska, 87042
- CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
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Nancy, Ranska, 54035
- Hopital Central; Neurologie
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Nantes, Ranska, 44093
- Hôpital Nord Laennec
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Rouen, Ranska, 76031
- CHU de Rouen Hopital; Service de Neurologie
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Strasbourg, Ranska, 67091
- Hôpital Civil de Strasbourg
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Berlin, Saksa, 12203
- Univ Berlin; Klin fur Psychi & Psycho Charite
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Günzburg, Saksa, 89312
- Bezirkskrankenhaus Günzburg
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Mannheim, Saksa, 68159
- Zentralinstitut fuer Seelische Gesundheit
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Munchen, Saksa, 81377
- Ludwig-Maximilians-Univ.
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Munchen, Saksa, 81675
- Klinikum rechts der Isar der Technischen Universität München
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Tubingen, Saksa, 72076
- Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
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Bath, Yhdistynyt kuningaskunta, BA1 3NG
- The Rice Centre; Royal United Hospital
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Brentford, Yhdistynyt kuningaskunta, TW8 8DS
- West London Research Unit; Brentford Lodge
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Brighton, Yhdistynyt kuningaskunta, BN2 5BE
- Royal Sussex County Hospital, CIRU Level 5
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Glasgow, Yhdistynyt kuningaskunta, G20 0XA
- Glasgow Memory Clinic
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London, GT LON, Yhdistynyt kuningaskunta, WC1N 3BG
- The National Hospital for Neurology & Neurosurgery; Dementia Research Center
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Southampton, Yhdistynyt kuningaskunta, SO30 3JB
- Moorgreen Hospital; Memory Assessment & Rsch Ctr
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Southampton, Yhdistynyt kuningaskunta, SO16 6YD
- Southampton General Hospital; Pharmacy
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Swindon, Yhdistynyt kuningaskunta, SN3 6BW
- Great Western Hosp.; Kingshill Research Ctr
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Arizona
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Phoenix, Arizona, Yhdysvallat, 85006
- Banner Alzheimer's Institute
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Scottsdale, Arizona, Yhdysvallat, 85259
- Mayo Clinic
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Sun City, Arizona, Yhdysvallat, 85351
- Banner Sun Health Research Insitute
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California
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Encino, California, Yhdysvallat, 91316
- Pharmacology Research Inst
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Fresno, California, Yhdysvallat, 93720
- Margolin Brain Institute
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La Jolla, California, Yhdysvallat, 92037
- Univ of CA San Diego; Neurosciences Comp.Alzheimer's
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Los Angeles, California, Yhdysvallat, 90095
- University of California Los Angeles (UCLA)
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Los Angeles, California, Yhdysvallat, 90033
- USC School of Medicine
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Newport Beach, California, Yhdysvallat, 92660
- Pharmacology Research Inst
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Oxnard, California, Yhdysvallat, 93030
- Pacific Neuroscience Med Grp
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Palo Alto, California, Yhdysvallat, 94304
- Stanford Univ Medical Center
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Sacramento, California, Yhdysvallat, 95817
- University of California Davis Medical System
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San Diego, California, Yhdysvallat, 92103
- Pacific Research Network - PRN
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San Francisco, California, Yhdysvallat, 94117
- Uni of California San Francisco
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Santa Rosa, California, Yhdysvallat, 95403
- Redwood Regional Medical Group
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Connecticut
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New Haven, Connecticut, Yhdysvallat, 06511
- Yale University
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Florida
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Boca Raton, Florida, Yhdysvallat, 33431
- Florida Atlantic University; College of Medicine
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Brooksville, Florida, Yhdysvallat, 34601
- Meridien Research
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Delray Beach, Florida, Yhdysvallat, 33445
- Brain Matters Research, Inc.
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Miami, Florida, Yhdysvallat, 33137
- Miami Jewish Health Systems; Clinical Research
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Naples, Florida, Yhdysvallat, 34105
- Collier Neurologic Specialists
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Orlando, Florida, Yhdysvallat, 32806
- Bioclinica Research
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Tampa, Florida, Yhdysvallat, 33609
- Axiom Clinical Research of Florida
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West Palm Beach, Florida, Yhdysvallat, 33407
- Premiere Research Institute
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Georgia
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Decatur, Georgia, Yhdysvallat, 30033
- DeKalb Neurology Associates
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Illinois
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Chicago, Illinois, Yhdysvallat, 60612
- Rush Alzheimer's Disease Cntr.
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Elk Grove Village, Illinois, Yhdysvallat, 60007
- Alexian Brothers Neurosci Inst
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Indiana
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Indianapolis, Indiana, Yhdysvallat, 46202
- Indiana Univ School of Med
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Louisiana
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New Orleans, Louisiana, Yhdysvallat, 70114
- Louisiana Research Associates
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Mississippi
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Hattiesburg, Mississippi, Yhdysvallat, 39401
- Hattiesburg Clinic
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Missouri
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Saint Louis, Missouri, Yhdysvallat, 63132
- Millennium Psychiatric Associates, LLC
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Nevada
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Las Vegas, Nevada, Yhdysvallat, 89106
- Cleveland Clinic Lou Ruvo; Center for Brain Research
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New Jersey
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Eatontown, New Jersey, Yhdysvallat, 07724
- Memory Enhancement Center of America, Inc.
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Mount Arlington, New Jersey, Yhdysvallat, 07856
- NeuroCognitive Institute
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New York
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Latham, New York, Yhdysvallat, 12210
- Empire Neurology, PC
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Manhasset, New York, Yhdysvallat, 11030
- Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
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New York, New York, Yhdysvallat, 10032
- Columbia University Medical Center
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Rochester, New York, Yhdysvallat, 14627
- University of Rochester Medical Center; Monroe Community Hospital
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Rochester, New York, Yhdysvallat, 14642
- Investigational Drug Service; Univ of Rochester Medical Ctr
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North Carolina
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Raleigh, North Carolina, Yhdysvallat, 27607-6520
- Raleigh Neurology Associates
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Oregon
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Portland, Oregon, Yhdysvallat, 97210
- Summit Research Network Inc.
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Pennsylvania
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Jenkintown, Pennsylvania, Yhdysvallat, 19046
- The Clinical Trial Center, LLC
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Rhode Island
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East Providence, Rhode Island, Yhdysvallat, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, Yhdysvallat, 02906
- Butler Hospital
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South Carolina
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North Charleston, South Carolina, Yhdysvallat, 29425
- Medical Uni of South Carolina
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Texas
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Houston, Texas, Yhdysvallat, 77030
- Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
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Vermont
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Bennington, Vermont, Yhdysvallat, 05201
- Clinical Neuroscience Research Associates, Inc.
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
50 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
Aikaikkuna: 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
Aikaikkuna: 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
|
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Percentage of Participants by Severity of AEs
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
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Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)
Aikaikkuna: 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
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Perjantai 7. joulukuuta 2012
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 8. helmikuuta 2017
Opintojen valmistuminen (Todellinen)
Keskiviikko 8. helmikuuta 2017
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 6. marraskuuta 2012
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 6. marraskuuta 2012
Ensimmäinen Lähetetty (Arvio)
Torstai 8. marraskuuta 2012
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 20. helmikuuta 2020
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 18. helmikuuta 2020
Viimeksi vahvistettu
Lauantai 1. helmikuuta 2020
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- GN28525
- 2012-003242-33 (EudraCT-numero)
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Joo
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
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