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

Alzheimer's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343966
• Other study ID #: ABE4869g
• Secondary ID: ABBYGN00761
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2011
• Last updated: July 10, 2017
• Start date: April 30, 2011
• Est. completion date: February 28, 2014

Study information

• Verified date: July 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: February 28, 2014
• Est. primary completion date: February 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• MABT5102A
Repeating subcutaneous injection
• MABT5102A
Repeating intravenous infusion
• placebo
Repeating subcutaneous injection
• placebo
Repeating intravenous infusion

Locations

Country	Name	City	State
Canada	Jbn Medical Diagnostic Services Inc.	Burlington	Ontario
Canada	Clinique Neuro Rive-Sud	Greenfield Park	Quebec
Canada	Capitol District Health Authority	Halilfax	Nova Scotia
Canada	The Med Arts Health Rsrch Grp	Kelowna	British Columbia
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	Saibal Nandy Professional Corporation	Medicine Hat	Alberta
Canada	Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique	Montreal	Quebec
Canada	Bruyere Continuing Care	Ottawa	Ontario
Canada	The Med Arts Health Rsrch Grp	Penticton	British Columbia
Canada	Kawartha Regional Memory Clinic	Peterborough	Ontario
Canada	CHAUQ Hopital Enfant-Jesus	Quebec City	Quebec
Canada	Toronto Memory Program (Neurology Research Inc.)	Toronto	Ontario
Canada	University of British Columbia Hospital; Division of Neurology	Vancouver	British Columbia
Canada	McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric	Verdun	Quebec
France	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
Germany	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	Inst fur Stedien zur Psych Ges	Mannheim
Germany	Zentralinstitut fuer Seelische Gesundheit	Mannheim
Germany	Psych Klin der LMU Muenchen	Muenchen
Germany	Klinikum rechts der Isar der Technischen Universität München	Munchen
Germany	Ludwig-Maximilians-Univ.	Munchen
Germany	Villa Sauer, Praxis für; Neurologie und Psychiatrie	Siegen
Germany	Universitätsklinik Tübingen; Psychiatrie und Psychotherapie	Tubingen
Spain	Hospital Perpetuo Socorro	Albacete
Spain	Hospital de Cruces; Servicio de Neurologia	Barakaldo	Vizcaya
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Clinica Ruber, 4 planta; Servicio de Neurologia	Madrid
Spain	Hospital General de Catalunya	San Cugat del Valles	Barcelona
Spain	Policlinica Guipuzcoa	San Sebastian	Guipuzcoa
Spain	Hospital Universitario Virgen de la Macarena;	Sevilla
United Kingdom	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	Moorgreen Hospital; Memory Assessment & Rsch Ctr	Southampton
United Kingdom	Southampton General Hospital; Pharmacy	Southampton
United Kingdom	Great Western Hosp.; Kingshill Research Ctr	Swindon
United States	Albany Medical College	Albany	New York
United States	Clinical Neuroscience Research Associates, Inc.	Bennington	Vermont
United States	Florida Atlantic University; College of Medicine	Boca Raton	Florida
United States	Meridien Research	Brooksville	Florida
United States	Rush Alzheimer's Disease Cntr.	Chicago	Illinois
United States	Millennium Psychiatric Associates, LLC	Creve Coeur	Missouri
United States	Brain Matters Research, Inc.	Delray Beach	Florida
United States	Alexian Brothers Neurosci Inst	Elk Grove Village	Illinois
United States	Pharmacology Research Inst	Encino	California
United States	Clinical Trials of America, Inc.	Eugene	Oregon
United States	Margolin Brain Institute	Fresno	California
United States	Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine	Houston	Texas
United States	IU Healthy Partners Adult Neurology Clinic	Indianapolis	Indiana
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	Univ of CA San Diego; Neurosciences Comp.Alzheimer's	La Jolla	California
United States	Empire Neurology, PC	Latham	New York
United States	USC School of Medicine	Los Angeles	California
United States	Miami Jewish Health Systems; Clinical Research	Miami	Florida
United States	NeuroCognitive Institute	Mount Arlington	New Jersey
United States	Collier Neurologic Specialists	Naples	Florida
United States	Yale University	New Haven	Connecticut
United States	Louisiana Research Associates	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Pharmacology Research Inst	Newport Beach	California
United States	Medical Uni of South Carolina	North Charleston	South Carolina
United States	Compass Research	Orlando	Florida
United States	Hope Research Institute	Phoenix	Arizona
United States	Summit Research Network Inc.	Portland	Oregon
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Investigational Drug Service; Univ of Rochester Medical Ctr	Rochester	New York
United States	University of Rochester Medical Center; Monroe Community Hospital	Rochester	New York
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	Mayo Clinic	Scottsdale	Arizona
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	Neurology & Neuroscience Ctr of Ohio	Toledo	Ohio
United States	Memory Enhancement Center of NJ, Inc.	Toms River	New Jersey
United States	Premiere Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score		From baseline to Week 73
Primary	Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score		From baseline to Week 73
Secondary	Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score		From baseline to Week 73