A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

July 10, 2017 updated by: Genentech, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
448

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Medicine Hat, Alberta, Canada, T1B 4E7
        • Saibal Nandy Professional Corporation
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3G8
        • The Med Arts Health Rsrch Grp
      • Penticton, British Columbia, Canada, V2A 5C8
        • 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
      • Kingston, Ontario, Canada, K7L 4X3
        • Providence Care Centre; Mental Health Site
      • 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 Regional Memory Clinic
      • 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
  • France
      • Bordeaux, France, 33000
        • Groupe Hospitalier Pellegrin
      • Bron, France, 69677
        • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
      • Limoges, France, 87042
        • CHU Limoges
      • Nantes, France, 44093
        • Hôpital Nord Laennec
      • Nice, France, 06003
        • Hôpital de Cimiez
      • Paris, France, 75013
        • Hôpital Broca
      • Rouen, France, 76031
        • CHU de Rouen Hopital; Service de Neurologie
      • Strasbourg, France, 67098
        • Hopital Hautepierre; Centre dInvestigation Clinique
      • Toulouse, France, 31059
        • Hôpital Casselardit; Cons memoire
  • Germany
      • Berlin, Germany, 12203
        • Univ Berlin; Klin fur Psychi & Psycho Charite
      • Berlin, Germany, 10626
        • Studienambulanz emovis GmbH; St. Joseph Krankenhaus
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen; Augenklinik
      • Günzburg, Germany, 89312
        • Bezirkskrankenhaus Günzburg
      • Mannheim, Germany, 68159
        • Zentralinstitut fuer Seelische Gesundheit
      • Mannheim, Germany, 68165
        • Inst fur Stedien zur Psych Ges
      • Muenchen, Germany, 80336
        • Psych Klin der LMU Muenchen
      • Munchen, Germany, 81377
        • Ludwig-Maximilians-Univ.
      • Munchen, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universität München
      • Siegen, Germany, 57072
        • Villa Sauer, Praxis für; Neurologie und Psychiatrie
      • Tubingen, Germany, 72076
        • Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
  • Spain
      • Albacete, Spain, 02006
        • Hospital Perpetuo Socorro
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28006
        • Clinica Ruber, 4 planta; Servicio de Neurologia
      • Sevilla, Spain, 41071
        • Hospital Universitario Virgen de la Macarena;
    • Barcelona
      • San Cugat del Valles, Barcelona, Spain, 08195
        • Hospital General De Catalunya
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20009
        • Policlínica Guipuzcoa
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces; Servicio de Neurologia
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • The Rice Centre; Royal United Hospital
      • Brentford, United Kingdom, TW8 8DS
        • West London Research Unit; Brentford Lodge
      • Brighton, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital, CIRU Level 5
      • Glasgow, United Kingdom, G20 0XA
        • Glasgow Memory Clinic
      • London, United Kingdom, NW1 9DB
        • Camden Mews Day Hospital; Camden and Islington
      • London, GT LON, United Kingdom, WC1N 3BG
        • The National Hospital for Neurology & Neurosurgery; Dementia Research Center
      • Southampton, United Kingdom, SO30 3JB
        • Moorgreen Hospital; Memory Assessment & Rsch Ctr
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital; Pharmacy
      • Swindon, United Kingdom, SN3 6BW
        • Great Western Hosp.; Kingshill Research Ctr
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Encino, California, United States, 91316
        • Pharmacology Research Inst
      • Fresno, California, United States, 93720
        • Margolin Brain Institute
      • La Jolla, California, United States, 92037
        • Univ of CA San Diego; Neurosciences Comp.Alzheimer's
      • Los Angeles, California, United States, 90033
        • USC School of Medicine
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Inst
      • Sacramento, California, United States, 95817
        • University of California Davis Medical System
      • San Diego, California, United States, 92103
        • Pacific Research Network - PRN
      • San Francisco, California, United States, 94117
        • Uni of California San Francisco
      • Santa Monica, California, United States, 90025
        • Neurological Research Inst
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Florida Atlantic University; College of Medicine
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research, Inc.
      • Miami, Florida, United States, 33137
        • Miami Jewish Health Systems; Clinical Research
      • Naples, Florida, United States, 34102
        • Collier Neurologic Specialists
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research of Florida
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Alzheimer's Disease Cntr.
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Neurosci Inst
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Healthy Partners Adult Neurology Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70114
        • Louisiana Research Associates
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Millennium Psychiatric Associates, LLC
    • New Jersey
      • Mount Arlington, New Jersey, United States, 07856
        • NeuroCognitive Institute
      • Toms River, New Jersey, United States, 08755
        • Memory Enhancement Center of NJ, Inc.
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Latham, New York, United States, 12210
        • Empire Neurology, PC
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Rochester, New York, United States, 14627
        • University of Rochester Medical Center; Monroe Community Hospital
      • Rochester, New York, United States, 14642
        • Investigational Drug Service; Univ of Rochester Medical Ctr
    • North Carolina
      • Raleigh, North Carolina, United States, 27607-6520
        • Raleigh Neurology Associates
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Neurology & Neuroscience Ctr of Ohio
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Clinical Trials of America, Inc.
      • Portland, Oregon, United States, 97210
        • Summit Research Network Inc.
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
    • South Carolina
      • North Charleston, South Carolina, United States, 29425
        • Medical Uni of South Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Clinical Neuroscience Research Associates, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Subcutaneous cohort exp
Drug: MABT5102A
Repeating subcutaneous injection
Drug: MABT5102A
Repeating intravenous infusion
Experimental: Part 2: Intravenous cohort exp
Drug: MABT5102A
Repeating subcutaneous injection
Drug: MABT5102A
Repeating intravenous infusion
Placebo Comparator: Part 1: Subcutaneous cohort
Repeating subcutaneous injection
Drug: placebo
Repeating subcutaneous injection
Drug: placebo
Repeating intravenous infusion
Placebo Comparator: Part 2: Intravenous cohort
Repeating intravenous infusion
Drug: placebo
Repeating subcutaneous injection
Drug: placebo
Repeating intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score
Time Frame: From baseline to Week 73
From baseline to Week 73
Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score
Time Frame: From baseline to Week 73
From baseline to Week 73

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score
Time Frame: From baseline to Week 73
From baseline to Week 73

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Robert Paul, M.D., Ph.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABE4869g
  • ABBY (Other Identifier: Genentech)
  • GN00761 (Other Identifier: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings