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

This study is currently recruiting participants.
Verified November 2012 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01343966
First received: April 27, 2011
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: MABT5102A
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score [ Time Frame: From baseline to Week 73 ] [ Designated as safety issue: No ]
  • Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score [ Time Frame: From baseline to Week 73 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score [ Time Frame: From baseline to Week 73 ] [ Designated as safety issue: No ]

Estimated Enrollment: 372
Study Start Date: April 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: MABT5102A
Repeating subcutaneous injection
Drug: placebo
Repeating subcutaneous injection
Experimental: B Drug: MABT5102A
Repeating intravenous infusion
Drug: placebo
Repeating intravenous infusion

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable AD according to the NINCDS-ADRDA criteria
  • MMSE score of 18-26 points at screening
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343966

Contacts
Contact: Please reference Study ID Number: ABE4869g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States, 85050
Active, not recruiting
Scottsdale, Arizona, United States, 85259
United States, California
Active, not recruiting
Encino, California, United States, 91316
Active, not recruiting
Fresno, California, United States, 93720
Active, not recruiting
La Jolla, California, United States, 92037
Active, not recruiting
Los Angeles, California, United States, 90033
Active, not recruiting
Newport Beach, California, United States, 92660
Active, not recruiting
Sacramento, California, United States, 95817
Active, not recruiting
San Diego, California, United States, 92103
Active, not recruiting
San Francisco, California, United States, 94143
Completed
Santa Monica, California, United States, 90404
United States, Connecticut
Active, not recruiting
New Haven, Connecticut, United States, 06520-8063
United States, Florida
Active, not recruiting
Boca Raton, Florida, United States, 33434
Active, not recruiting
Brooksville, Florida, United States, 34601
Active, not recruiting
Delray Beach, Florida, United States, 33445
Active, not recruiting
Miami, Florida, United States, 33137
Active, not recruiting
Naples, Florida, United States, 34102
Active, not recruiting
Orlando, Florida, United States, 32806
Active, not recruiting
Tampa, Florida, United States, 33609
Active, not recruiting
West Palm Beach, Florida, United States, 33407
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States, 60612
Active, not recruiting
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Louisiana
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New Orleans, Louisiana, United States, 70114
United States, Missouri
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Creve Coeur, Missouri, United States, 63141
United States, New Jersey
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Mount Arlington, New Jersey, United States, 07856
Active, not recruiting
Toms River, New Jersey, United States, 08755
United States, New York
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Albany, New York, United States, 12208
Active, not recruiting
Latham, New York, United States, 12210
Active, not recruiting
New York, New York, United States, 10032
Active, not recruiting
Rochester, New York, United States, 14620
Active, not recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Active, not recruiting
Raleigh, North Carolina, United States, 27607-6010
United States, Ohio
Active, not recruiting
Toledo, Ohio, United States, 43623
United States, Oregon
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Eugene, Oregon, United States, 97401
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Portland, Oregon, United States, 97210
United States, Pennsylvania
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Jenkintown, Pennsylvania, United States, 19046
United States, South Carolina
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North Charleston, South Carolina, United States, 29425
United States, Texas
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Houston, Texas, United States, 77030
United States, Vermont
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Bennington, Vermont, United States, 05201
Canada, Alberta
Recruiting
Medicine Hat, Alberta, Canada, T1B 4E7
Canada, British Columbia
Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 3G8
Active, not recruiting
Penticton, British Columbia, Canada, V2A 5C8
Active, not recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Nova Scotia
Active, not recruiting
Halilfax, Nova Scotia, Canada, B3H 2E1
Canada, Ontario
Active, not recruiting
Burlington, Ontario, Canada, L7M 4Y1
Active, not recruiting
Kingston, Ontario, Canada, K7L 5G2
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Kingston, Ontario, Canada, K7L 4X3
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London, Ontario, Canada, N6C 5J1
Active, not recruiting
Ottawa, Ontario, Canada, K1N 5C8
Active, not recruiting
Peterborough, Ontario, Canada, K9H 2P4
Recruiting
Toronto, Ontario, Canada, M5T 2S8
Active, not recruiting
Toronto, Ontario, Canada, M2J 5A3
Canada, Quebec
Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Active, not recruiting
Montreal, Quebec, Canada, H4H IR3
Active, not recruiting
Montreal, Quebec, Canada, H1T 2M4
Active, not recruiting
Quebec City, Quebec, Canada, G1J 1Z4
France
Recruiting
Bordeaux, France, 33000
Active, not recruiting
Bron, France, 69677
Active, not recruiting
Limoges, France, 87042
Active, not recruiting
Nantes, France, 44093
Recruiting
Nice, France, 06003
Recruiting
Paris, France, 75013
Active, not recruiting
Rouen, France, 76031
Active, not recruiting
Strasbourg, France, 67091
Recruiting
Toulouse, France, 31059
Germany
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Berlin, Germany, 14050
Recruiting
Berlin, Germany, 10626
Recruiting
Erlangen, Germany, 91054
Recruiting
Frankfurt, Germany, 60528
Active, not recruiting
Günzburg, Germany, 89312
Active, not recruiting
Mannheim, Germany, 68165
Active, not recruiting
Mannheim, Germany, 68159
Recruiting
Muenchen, Germany, 80336
Active, not recruiting
Munchen, Germany, D-81377
Active, not recruiting
München, Germany, 81675
Recruiting
Siegen, Germany, 57072
Active, not recruiting
Tubingen, Germany, 72076
Spain
Active, not recruiting
Albacete, Spain, 02006
Active, not recruiting
Barakaldo, Spain, 48903
Recruiting
Barcelona, Spain, 08035
Recruiting
Elche, Spain, 03203
Recruiting
Madrid, Spain, 28040
Active, not recruiting
Madrid, Spain, 28006
Recruiting
Madrid, Spain, 28905
Active, not recruiting
San Cugat Del Valles, Spain, 08195
Active, not recruiting
San Sebastian, Spain, 20009
Recruiting
Sevilla, Spain, 41071
United Kingdom
Active, not recruiting
Bath, United Kingdom, BA1 3NG
Not yet recruiting
Belfast, United Kingdom, BT9 7AB
Active, not recruiting
Brentford, United Kingdom, TW8 8DS
Active, not recruiting
Brighton, United Kingdom, BN2 5BE
Active, not recruiting
Glasgow, United Kingdom, G20 0XA
Active, not recruiting
London, United Kingdom, NW1 9DB
Active, not recruiting
London, Gt Lon, United Kingdom, WC1N 3BG
Active, not recruiting
Southampton, United Kingdom, SO16 6YD
Active, not recruiting
Southampton, United Kingdom, SO30 3JB
Active, not recruiting
Swindon, United Kingdom, SN3 6BW
Sponsors and Collaborators
Genentech
Investigators
Study Director: Robert Paul, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01343966     History of Changes
Other Study ID Numbers: ABE4869g, ABBY, GN00761
Study First Received: April 27, 2011
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013