A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
3 other identifiers
interventional
448
6 countries
92
Brief Summary
This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
Typical duration for phase_2
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedStudy Start
First participant enrolled
April 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2014
CompletedJuly 12, 2017
July 1, 2017
2.8 years
April 27, 2011
July 10, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score
From baseline to Week 73
Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score
From baseline to Week 73
Secondary Outcomes (1)
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score
From baseline to Week 73
Study Arms (4)
Part 1: Subcutaneous cohort exp
EXPERIMENTALPart 2: Intravenous cohort exp
EXPERIMENTALPart 1: Subcutaneous cohort
PLACEBO COMPARATORRepeating subcutaneous injection
Part 2: Intravenous cohort
PLACEBO COMPARATORRepeating intravenous infusion
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria
- Mini-Mental State Examination (MMSE) score of 18-26 points at screening
- Geriatric Depression Scale (GDS-15) score of \< 6
- 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.
You may not qualify if:
- Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient'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 (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (92)
Hope Research Institute
Phoenix, Arizona, 85050, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Pharmacology Research Inst
Encino, California, 91316, United States
Margolin Brain Institute
Fresno, California, 93720, United States
Univ of CA San Diego; Neurosciences Comp.Alzheimer's
La Jolla, California, 92037, United States
USC School of Medicine
Los Angeles, California, 90033, United States
Pharmacology Research Inst
Newport Beach, California, 92660, United States
University of California Davis Medical System
Sacramento, California, 95817, United States
Pacific Research Network - PRN
San Diego, California, 92103, United States
Uni of California San Francisco
San Francisco, California, 94117, United States
Neurological Research Inst
Santa Monica, California, 90025, United States
Yale University
New Haven, Connecticut, 06511, United States
Florida Atlantic University; College of Medicine
Boca Raton, Florida, 33431, United States
Meridien Research
Brooksville, Florida, 34601, United States
Brain Matters Research, Inc.
Delray Beach, Florida, 33445, United States
Miami Jewish Health Systems; Clinical Research
Miami, Florida, 33137, United States
Collier Neurologic Specialists
Naples, Florida, 34102, United States
Compass Research
Orlando, Florida, 32806, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Rush Alzheimer's Disease Cntr.
Chicago, Illinois, 60612, United States
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, 60007, United States
IU Healthy Partners Adult Neurology Clinic
Indianapolis, Indiana, 46202, United States
Louisiana Research Associates
New Orleans, Louisiana, 70114, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, 63141, United States
NeuroCognitive Institute
Mount Arlington, New Jersey, 07856, United States
Memory Enhancement Center of NJ, Inc.
Toms River, New Jersey, 08755, United States
Albany Medical College
Albany, New York, 12208, United States
Empire Neurology, PC
Latham, New York, 12210, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester Medical Center; Monroe Community Hospital
Rochester, New York, 14627, United States
Investigational Drug Service; Univ of Rochester Medical Ctr
Rochester, New York, 14642, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607-6520, United States
Neurology & Neuroscience Ctr of Ohio
Toledo, Ohio, 43623, United States
Clinical Trials of America, Inc.
Eugene, Oregon, 97401, United States
Summit Research Network Inc.
Portland, Oregon, 97210, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Medical Uni of South Carolina
North Charleston, South Carolina, 29425, United States
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
Houston, Texas, 77030, United States
Clinical Neuroscience Research Associates, Inc.
Bennington, Vermont, 05201, United States
Saibal Nandy Professional Corporation
Medicine Hat, Alberta, T1B 4E7, Canada
The Med Arts Health Rsrch Grp
Kelowna, British Columbia, V1Y 3G8, Canada
The Med Arts Health Rsrch Grp
Penticton, British Columbia, V2A 5C8, Canada
University of British Columbia Hospital; Division of Neurology
Vancouver, British Columbia, V6T 2B5, Canada
Capitol District Health Authority
Halilfax, Nova Scotia, B3H 2E1, Canada
Jbn Medical Diagnostic Services Inc.
Burlington, Ontario, L7M 4Y1, Canada
Hotel Dieu Hospital
Kingston, Ontario, K7L 2V7, Canada
Providence Care Centre; Mental Health Site
Kingston, Ontario, K7L 4X3, Canada
St. Joseph's HC-Parkwood Hosp
London, Ontario, N6C 5J1, Canada
Bruyere Continuing Care
Ottawa, Ontario, K1N 5C8, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, K9H 2P4, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, M3B 2S7, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, J4V 2J2, Canada
Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
Montreal, Quebec, H1T 2M4, Canada
CHAUQ Hopital Enfant-Jesus
Québec, Quebec, G1J 1Z4, Canada
McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
Verdun, Quebec, H4H 1R3, Canada
Groupe Hospitalier Pellegrin
Bordeaux, 33000, France
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, 69677, France
Chu Limoges
Limoges, 87042, France
Hopital Nord Laennec
Nantes, 44093, France
Hopital de Cimiez
Nice, 06003, France
Hopital Broca
Paris, 75013, France
CHU de Rouen Hopital; Service de Neurologie
Rouen, 76031, France
Hopital Hautepierre; Centre dInvestigation Clinique
Strasbourg, 67098, France
Hôpital Casselardit; Cons memoire
Toulouse, 31059, France
Studienambulanz emovis GmbH; St. Joseph Krankenhaus
Berlin, 10626, Germany
Univ Berlin; Klin fur Psychi & Psycho Charite
Berlin, 12203, Germany
Universitätsklinikum Erlangen; Augenklinik
Erlangen, 91054, Germany
Bezirkskrankenhaus Günzburg
Günzburg, 89312, Germany
Zentralinstitut fuer Seelische Gesundheit
Mannheim, 68159, Germany
Inst fur Stedien zur Psych Ges
Mannheim, 68165, Germany
Psych Klin der LMU Muenchen
München, 80336, Germany
Ludwig-Maximilians-Univ.
München, 81377, Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
Villa Sauer, Praxis für; Neurologie und Psychiatrie
Siegen, 57072, Germany
Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
Tübingen, 72076, Germany
Hospital General de Catalunya
San Cugat Del Valles, Barcelona, 08195, Spain
Policlinica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, 20009, Spain
Hospital de Cruces; Servicio de Neurologia
Barakaldo, Vizcaya, 48903, Spain
Hospital Perpetuo Socorro
Albacete, 02006, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Clinica Ruber, 4 planta; Servicio de Neurologia
Madrid, 28006, Spain
Hospital Universitario Virgen de la Macarena;
Seville, 41071, Spain
The Rice Centre; Royal United Hospital
Bath, BA1 3NG, United Kingdom
West London Research Unit; Brentford Lodge
Brentford, TW8 8DS, United Kingdom
Royal Sussex County Hospital, CIRU Level 5
Brighton, BN2 5BE, United Kingdom
Glasgow Memory Clinic
Glasgow, G20 0XA, United Kingdom
Camden Mews Day Hospital; Camden and Islington
London, NW1 9DB, United Kingdom
The National Hospital for Neurology & Neurosurgery; Dementia Research Center
London, GT LON, WC1N 3BG, United Kingdom
Southampton General Hospital; Pharmacy
Southampton, SO16 6YD, United Kingdom
Moorgreen Hospital; Memory Assessment & Rsch Ctr
Southampton, SO30 3JB, United Kingdom
Great Western Hosp.; Kingshill Research Ctr
Swindon, SN3 6BW, United Kingdom
Related Publications (2)
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.
PMID: 36946448DERIVEDYoshida 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.
PMID: 31969177DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Paul, M.D., Ph.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2011
First Posted
April 28, 2011
Study Start
April 30, 2011
Primary Completion
February 28, 2014
Study Completion
February 28, 2014
Last Updated
July 12, 2017
Record last verified: 2017-07