A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
NCT ID: NCT01343966
Last Updated: 2017-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
448 participants
INTERVENTIONAL
2011-04-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1: Subcutaneous cohort exp
MABT5102A
Repeating subcutaneous injection
Part 2: Intravenous cohort exp
MABT5102A
Repeating intravenous infusion
Part 1: Subcutaneous cohort
Repeating subcutaneous injection
placebo
Repeating subcutaneous injection
Part 2: Intravenous cohort
Repeating intravenous infusion
placebo
Repeating intravenous infusion
Interventions
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MABT5102A
Repeating subcutaneous injection
MABT5102A
Repeating intravenous infusion
placebo
Repeating subcutaneous injection
placebo
Repeating intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination (MMSE) score of 18-26 points at screening
* Geriatric Depression Scale (GDS-15) score of \< 6
* Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)
* If receiving concurrent AD treatment, patient must be on the medication for at least 3 months at a stable dose for at least 2 months prior to randomization.
Exclusion Criteria
* History or presence of clinically evident vascular disease potentially affecting the brain
* History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma
* Hospitalization within 4 weeks prior to screening
* Previous treatment with MABT5102A or any other therapeutic that targets Abeta
* Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed
50 Years
80 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Paul, M.D., Ph.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Hope Research Institute
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, 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
Pharmacology Research Inst
Newport Beach, 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
Neurological Research Inst
Santa Monica, 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
Compass Research
Orlando, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Rush Alzheimer's Disease Cntr.
Chicago, Illinois, United States
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, United States
IU Healthy Partners Adult Neurology Clinic
Indianapolis, Indiana, United States
Louisiana Research Associates
New Orleans, Louisiana, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States
NeuroCognitive Institute
Mount Arlington, New Jersey, United States
Memory Enhancement Center of NJ, Inc.
Toms River, New Jersey, United States
Albany Medical College
Albany, New York, United States
Empire Neurology, PC
Latham, 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
Neurology & Neuroscience Ctr of Ohio
Toledo, Ohio, United States
Clinical Trials of America, Inc.
Eugene, Oregon, United States
Summit Research Network Inc.
Portland, Oregon, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 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
Saibal Nandy Professional Corporation
Medicine Hat, Alberta, Canada
The Med Arts Health Rsrch Grp
Kelowna, British Columbia, Canada
The Med Arts Health Rsrch Grp
Penticton, 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
Providence Care Centre; Mental Health Site
Kingston, Ontario, Canada
St. Joseph's HC-Parkwood Hosp
London, Ontario, Canada
Bruyere Continuing Care
Ottawa, Ontario, Canada
Kawartha Regional Memory Clinic
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
Groupe Hospitalier Pellegrin
Bordeaux, , France
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, , France
Chu Limoges
Limoges, , France
Hopital Nord Laennec
Nantes, , France
Hopital de Cimiez
Nice, , France
Hopital Broca
Paris, , France
CHU de Rouen Hopital; Service de Neurologie
Rouen, , France
Hopital Hautepierre; Centre dInvestigation Clinique
Strasbourg, , France
Hôpital Casselardit; Cons memoire
Toulouse, , France
Studienambulanz emovis GmbH; St. Joseph Krankenhaus
Berlin, , Germany
Univ Berlin; Klin fur Psychi & Psycho Charite
Berlin, , Germany
Universitätsklinikum Erlangen; Augenklinik
Erlangen, , Germany
Bezirkskrankenhaus Günzburg
Günzburg, , Germany
Zentralinstitut fuer Seelische Gesundheit
Mannheim, , Germany
Inst fur Stedien zur Psych Ges
Mannheim, , Germany
Psych Klin der LMU Muenchen
München, , Germany
Ludwig-Maximilians-Univ.
München, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Villa Sauer, Praxis für; Neurologie und Psychiatrie
Siegen, , Germany
Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
Tübingen, , Germany
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
Hospital Perpetuo Socorro
Albacete, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Clinica Ruber, 4 planta; Servicio de Neurologia
Madrid, , Spain
Hospital Universitario Virgen de la Macarena;
Seville, , 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
Camden Mews Day Hospital; Camden and Islington
London, , 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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References
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Polhamus DG, Dolton MJ, Rogers JA, Honigberg L, Jin JY, Quartino A. Longitudinal Exposure-Response Modeling of Multiple Indicators of Alzheimer's Disease Progression. J Prev Alzheimers Dis. 2023;10(2):212-222. doi: 10.14283/jpad.2023.13.
Yoshida K, Moein A, Bittner T, Ostrowitzki S, Lin H, Honigberg L, Jin JY, Quartino A. Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2020 Jan 22;12(1):16. doi: 10.1186/s13195-020-0580-2.
Other Identifiers
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ABBY
Identifier Type: OTHER
Identifier Source: secondary_id
GN00761
Identifier Type: OTHER
Identifier Source: secondary_id
ABE4869g
Identifier Type: -
Identifier Source: org_study_id
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