Clinical trial NCT01343966: A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-04-28
Enrollment: 448
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score
timeFrame: From baseline to Week 73
measure: Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score
timeFrame: From baseline to Week 73
Secondary outcomes:
measure: Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score
timeFrame: From baseline to Week 73
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Encino
country: United States
facility: Pharmacology Research Inst
state: California
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: La Jolla
country: United States
facility: Univ of CA San Diego; Neurosciences Comp.Alzheimer's
state: California
city: Los Angeles
country: United States
facility: USC School of Medicine
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Inst
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical System
state: California
city: San Diego
country: United States
facility: Pacific Research Network - PRN
state: California
city: San Francisco
country: United States
facility: Uni of California San Francisco
state: California
city: Santa Monica
country: United States
facility: Neurological Research Inst
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boca Raton
country: United States
facility: Florida Atlantic University; College of Medicine
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research, Inc.
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems; Clinical Research
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Chicago
country: United States
facility: Rush Alzheimer's Disease Cntr.
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Neurosci Inst
state: Illinois
city: Indianapolis
country: United States
facility: IU Healthy Partners Adult Neurology Clinic
state: Indiana
city: New Orleans
country: United States
facility: Louisiana Research Associates
state: Louisiana
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associates, LLC
state: Missouri
city: Mount Arlington
country: United States
facility: NeuroCognitive Institute
state: New Jersey
city: Toms River
country: United States
facility: Memory Enhancement Center of NJ, Inc.
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Latham
country: United States
facility: Empire Neurology, PC
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center; Monroe Community Hospital
state: New York
city: Rochester
country: United States
facility: Investigational Drug Service; Univ of Rochester Medical Ctr
state: New York
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Toledo
country: United States
facility: Neurology & Neuroscience Ctr of Ohio
state: Ohio
city: Eugene
country: United States
facility: Clinical Trials of America, Inc.
state: Oregon
city: Portland
country: United States
facility: Summit Research Network Inc.
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: North Charleston
country: United States
facility: Medical Uni of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
state: Texas
city: Bennington
country: United States
facility: Clinical Neuroscience Research Associates, Inc.
state: Vermont
city: Medicine Hat
country: Canada
facility: Saibal Nandy Professional Corporation
state: Alberta
city: Kelowna
country: Canada
facility: The Med Arts Health Rsrch Grp
state: British Columbia
city: Penticton
country: Canada
facility: The Med Arts Health Rsrch Grp
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia Hospital; Division of Neurology
state: British Columbia
city: Halilfax
country: Canada
facility: Capitol District Health Authority
state: Nova Scotia
city: Burlington
country: Canada
facility: Jbn Medical Diagnostic Services Inc.
state: Ontario
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: Kingston
country: Canada
facility: Providence Care Centre; Mental Health Site
state: Ontario
city: London
country: Canada
facility: St. Joseph's HC-Parkwood Hosp
state: Ontario
city: Ottawa
country: Canada
facility: Bruyere Continuing Care
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Regional Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program (Neurology Research Inc.)
state: Ontario
city: Greenfield Park
country: Canada
facility: Clinique Neuro Rive-Sud
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
state: Quebec
city: Quebec City
country: Canada
facility: CHAUQ Hopital Enfant-Jesus
state: Quebec
city: Verdun
country: Canada
facility: McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
state: Quebec
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Bron
country: France
facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
city: Limoges
country: France
facility: Chu Limoges
city: Nantes
country: France
facility: Hopital Nord Laennec
city: Nice
country: France
facility: Hopital de Cimiez
city: Paris
country: France
facility: Hopital Broca
city: Rouen
country: France
facility: CHU de Rouen Hopital; Service de Neurologie
city: Strasbourg
country: France
facility: Hopital Hautepierre; Centre dInvestigation Clinique
city: Toulouse
country: France
facility: Hôpital Casselardit; Cons memoire
city: Berlin
country: Germany
facility: Studienambulanz emovis GmbH; St. Joseph Krankenhaus
city: Berlin
country: Germany
facility: Univ Berlin; Klin fur Psychi & Psycho Charite
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Augenklinik
city: Günzburg
country: Germany
facility: Bezirkskrankenhaus Günzburg
city: Mannheim
country: Germany
facility: Zentralinstitut fuer Seelische Gesundheit
city: Mannheim
country: Germany
facility: Inst fur Stedien zur Psych Ges
city: Muenchen
country: Germany
facility: Psych Klin der LMU Muenchen
city: Munchen
country: Germany
facility: Ludwig-Maximilians-Univ.
city: Munchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Siegen
country: Germany
facility: Villa Sauer, Praxis für; Neurologie und Psychiatrie
city: Tubingen
country: Germany
facility: Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
city: San Cugat del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: San Sebastian
country: Spain
facility: Policlinica Guipuzcoa
state: Guipuzcoa
city: Barakaldo
country: Spain
facility: Hospital de Cruces; Servicio de Neurologia
state: Vizcaya
city: Albacete
country: Spain
facility: Hospital Perpetuo Socorro
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Clinica Ruber, 4 planta; Servicio de Neurologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena;
city: Bath
country: United Kingdom
facility: The Rice Centre; Royal United Hospital
city: Brentford
country: United Kingdom
facility: West London Research Unit; Brentford Lodge
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital, CIRU Level 5
city: Glasgow
country: United Kingdom
facility: Glasgow Memory Clinic
city: London, GT LON
country: United Kingdom
facility: The National Hospital for Neurology & Neurosurgery; Dementia Research Center
city: London
country: United Kingdom
facility: Camden Mews Day Hospital; Camden and Islington
city: Southampton
country: United Kingdom
facility: Southampton General Hospital; Pharmacy
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital; Memory Assessment & Rsch Ctr
city: Swindon
country: United Kingdom
facility: Great Western Hosp.; Kingshill Research Ctr
Study officials:
affiliation: Genentech, Inc.
name: Robert Paul, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.