A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab
18 februari 2020 bijgewerkt door: 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.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
360
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1Y 3G8
- The Med Arts Health Rsrch Grp
-
Vancouver, British Columbia, Canada, V6T 2B5
- University of British Columbia Hospital; Division of Neurology
-
-
Nova Scotia
-
Halilfax, Nova Scotia, Canada, B3H 2E1
- Capitol District Health Authority
-
-
Ontario
-
Burlington, Ontario, Canada, L7M 4Y1
- JBN Medical Diagnostic Services Inc.
-
Kingston, Ontario, Canada, K7L 2V7
- Hotel Dieu Hospital
-
London, Ontario, Canada, N6C 5J1
- St. Joseph's HC-Parkwood Hosp
-
Ottawa, Ontario, Canada, K1N 5C8
- Bruyere Continuing Care
-
Peterborough, Ontario, Canada, K9H 2P4
- Kawartha Centre - Redefining Healthy Aging
-
Toronto, Ontario, Canada, M3B 2S7
- Toronto Memory Program (Neurology Research Inc.)
-
-
Quebec
-
Greenfield Park, Quebec, Canada, J4V 2J2
- Clinique Neuro Rive-Sud
-
Montreal, Quebec, Canada, H1T 2M4
- Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
-
Quebec City, Quebec, Canada, G1J 1Z4
- CHAUQ Hopital Enfant-Jesus
-
Verdun, Quebec, Canada, H4H 1R3
- McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
-
-
-
-
-
Berlin, Duitsland, 12203
- Univ Berlin; Klin fur Psychi & Psycho Charite
-
Günzburg, Duitsland, 89312
- Bezirkskrankenhaus Günzburg
-
Mannheim, Duitsland, 68159
- Zentralinstitut fuer Seelische Gesundheit
-
Munchen, Duitsland, 81377
- Ludwig-Maximilians-Univ.
-
Munchen, Duitsland, 81675
- Klinikum rechts der Isar der Technischen Universität München
-
Tubingen, Duitsland, 72076
- Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
-
-
-
-
-
Bron, Frankrijk, 69677
- Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
-
Limoges, Frankrijk, 87042
- CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
-
Nancy, Frankrijk, 54035
- Hopital Central; Neurologie
-
Nantes, Frankrijk, 44093
- Hôpital Nord Laennec
-
Rouen, Frankrijk, 76031
- CHU de Rouen Hopital; Service de Neurologie
-
Strasbourg, Frankrijk, 67091
- Hôpital Civil de Strasbourg
-
-
-
-
-
Albacete, Spanje, 2006
- Complejo Hospitalario Universitario de Albacete
-
Madrid, Spanje, 28006
- Clinica Ruber, 4 planta; Servicio de Neurologia
-
-
Barcelona
-
BArcelon, Barcelona, Spanje, 08034
- Fundació ACE
-
San Cugat Del Valles, Barcelona, Spanje, 08195
- Hospital General De Catalunya
-
-
Guipuzcoa
-
San Sebastian, Guipuzcoa, Spanje, 20009
- Policlínica Guipuzcoa
-
-
Vizcaya
-
Barakaldo, Vizcaya, Spanje, 48903
- Hospital de Cruces; Servicio de Neurologia
-
-
-
-
-
Bath, Verenigd Koninkrijk, BA1 3NG
- The Rice Centre; Royal United Hospital
-
Brentford, Verenigd Koninkrijk, TW8 8DS
- West London Research Unit; Brentford Lodge
-
Brighton, Verenigd Koninkrijk, BN2 5BE
- Royal Sussex County Hospital, CIRU Level 5
-
Glasgow, Verenigd Koninkrijk, G20 0XA
- Glasgow Memory Clinic
-
London, GT LON, Verenigd Koninkrijk, WC1N 3BG
- The National Hospital for Neurology & Neurosurgery; Dementia Research Center
-
Southampton, Verenigd Koninkrijk, SO30 3JB
- Moorgreen Hospital; Memory Assessment & Rsch Ctr
-
Southampton, Verenigd Koninkrijk, SO16 6YD
- Southampton General Hospital; Pharmacy
-
Swindon, Verenigd Koninkrijk, SN3 6BW
- Great Western Hosp.; Kingshill Research Ctr
-
-
-
-
Arizona
-
Phoenix, Arizona, Verenigde Staten, 85006
- Banner Alzheimer's Institute
-
Scottsdale, Arizona, Verenigde Staten, 85259
- Mayo Clinic
-
Sun City, Arizona, Verenigde Staten, 85351
- Banner Sun Health Research Insitute
-
-
California
-
Encino, California, Verenigde Staten, 91316
- Pharmacology Research Inst
-
Fresno, California, Verenigde Staten, 93720
- Margolin Brain Institute
-
La Jolla, California, Verenigde Staten, 92037
- Univ of CA San Diego; Neurosciences Comp.Alzheimer's
-
Los Angeles, California, Verenigde Staten, 90095
- University of California Los Angeles (UCLA)
-
Los Angeles, California, Verenigde Staten, 90033
- USC School of Medicine
-
Newport Beach, California, Verenigde Staten, 92660
- Pharmacology Research Inst
-
Oxnard, California, Verenigde Staten, 93030
- Pacific Neuroscience Med Grp
-
Palo Alto, California, Verenigde Staten, 94304
- Stanford Univ Medical Center
-
Sacramento, California, Verenigde Staten, 95817
- University of California Davis Medical System
-
San Diego, California, Verenigde Staten, 92103
- Pacific Research Network - PRN
-
San Francisco, California, Verenigde Staten, 94117
- Uni of California San Francisco
-
Santa Rosa, California, Verenigde Staten, 95403
- Redwood Regional Medical Group
-
-
Connecticut
-
New Haven, Connecticut, Verenigde Staten, 06511
- Yale University
-
-
Florida
-
Boca Raton, Florida, Verenigde Staten, 33431
- Florida Atlantic University; College of Medicine
-
Brooksville, Florida, Verenigde Staten, 34601
- Meridien Research
-
Delray Beach, Florida, Verenigde Staten, 33445
- Brain Matters Research, Inc.
-
Miami, Florida, Verenigde Staten, 33137
- Miami Jewish Health Systems; Clinical Research
-
Naples, Florida, Verenigde Staten, 34105
- Collier Neurologic Specialists
-
Orlando, Florida, Verenigde Staten, 32806
- Bioclinica Research
-
Tampa, Florida, Verenigde Staten, 33609
- Axiom Clinical Research of Florida
-
West Palm Beach, Florida, Verenigde Staten, 33407
- Premiere Research Institute
-
-
Georgia
-
Decatur, Georgia, Verenigde Staten, 30033
- DeKalb Neurology Associates
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten, 60612
- Rush Alzheimer's Disease Cntr.
-
Elk Grove Village, Illinois, Verenigde Staten, 60007
- Alexian Brothers Neurosci Inst
-
-
Indiana
-
Indianapolis, Indiana, Verenigde Staten, 46202
- Indiana Univ School of Med
-
-
Louisiana
-
New Orleans, Louisiana, Verenigde Staten, 70114
- Louisiana Research Associates
-
-
Mississippi
-
Hattiesburg, Mississippi, Verenigde Staten, 39401
- Hattiesburg Clinic
-
-
Missouri
-
Saint Louis, Missouri, Verenigde Staten, 63132
- Millennium Psychiatric Associates, LLC
-
-
Nevada
-
Las Vegas, Nevada, Verenigde Staten, 89106
- Cleveland Clinic Lou Ruvo; Center for Brain Research
-
-
New Jersey
-
Eatontown, New Jersey, Verenigde Staten, 07724
- Memory Enhancement Center of America, Inc.
-
Mount Arlington, New Jersey, Verenigde Staten, 07856
- NeuroCognitive Institute
-
-
New York
-
Latham, New York, Verenigde Staten, 12210
- Empire Neurology, PC
-
Manhasset, New York, Verenigde Staten, 11030
- Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
-
New York, New York, Verenigde Staten, 10032
- Columbia University Medical Center
-
Rochester, New York, Verenigde Staten, 14627
- University of Rochester Medical Center; Monroe Community Hospital
-
Rochester, New York, Verenigde Staten, 14642
- Investigational Drug Service; Univ of Rochester Medical Ctr
-
-
North Carolina
-
Raleigh, North Carolina, Verenigde Staten, 27607-6520
- Raleigh Neurology Associates
-
-
Oregon
-
Portland, Oregon, Verenigde Staten, 97210
- Summit Research Network Inc.
-
-
Pennsylvania
-
Jenkintown, Pennsylvania, Verenigde Staten, 19046
- The Clinical Trial Center, LLC
-
-
Rhode Island
-
East Providence, Rhode Island, Verenigde Staten, 02914
- Rhode Island Mood & Memory Research Institute
-
Providence, Rhode Island, Verenigde Staten, 02906
- Butler Hospital
-
-
South Carolina
-
North Charleston, South Carolina, Verenigde Staten, 29425
- Medical Uni of South Carolina
-
-
Texas
-
Houston, Texas, Verenigde Staten, 77030
- Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
-
-
Vermont
-
Bennington, Vermont, Verenigde Staten, 05201
- Clinical Neuroscience Research Associates, Inc.
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
50 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
|
Up to 50 months
|
|
Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation
Tijdsspanne: 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.
|
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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
7 december 2012
Primaire voltooiing (Werkelijk)
8 februari 2017
Studie voltooiing (Werkelijk)
8 februari 2017
Studieregistratiedata
Eerst ingediend
6 november 2012
Eerst ingediend dat voldeed aan de QC-criteria
6 november 2012
Eerst geplaatst (Schatting)
8 november 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 februari 2020
Laatste update ingediend die voldeed aan QC-criteria
18 februari 2020
Laatst geverifieerd
1 februari 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GN28525
- 2012-003242-33 (EudraCT-nummer)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .