Back to resultsA Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MABT5102A
MABT5102A
placebo
placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Hope Research Institute
- Mayo Clinic
- Pharmacology Research Inst
- Margolin Brain Institute
- Univ of CA San Diego; Neurosciences Comp.Alzheimer's
- USC School of Medicine
- Pharmacology Research Inst
- University of California Davis Medical System
- Pacific Research Network - PRN
- Uni of California San Francisco
- Neurological Research Inst
- Yale University
- Florida Atlantic University; College of Medicine
- Meridien Research
- Brain Matters Research, Inc.
- Miami Jewish Health Systems; Clinical Research
- Collier Neurologic Specialists
- Compass Research
- Axiom Clinical Research of Florida
- Premiere Research Institute
- Rush Alzheimer's Disease Cntr.
- Alexian Brothers Neurosci Inst
- IU Healthy Partners Adult Neurology Clinic
- Louisiana Research Associates
- Millennium Psychiatric Associates, LLC
- NeuroCognitive Institute
- Memory Enhancement Center of NJ, Inc.
- Albany Medical College
- Empire Neurology, PC
- Columbia University Medical Center
- University of Rochester Medical Center; Monroe Community Hospital
- Investigational Drug Service; Univ of Rochester Medical Ctr
- Raleigh Neurology Associates
- Neurology & Neuroscience Ctr of Ohio
- Clinical Trials of America, Inc.
- Summit Research Network Inc.
- The Clinical Trial Center, LLC
- Medical Uni of South Carolina
- Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
- Clinical Neuroscience Research Associates, Inc.
- Saibal Nandy Professional Corporation
- The Med Arts Health Rsrch Grp
- The Med Arts Health Rsrch Grp
- University of British Columbia Hospital; Division of Neurology
- Capitol District Health Authority
- Jbn Medical Diagnostic Services Inc.
- Hotel Dieu Hospital
- Providence Care Centre; Mental Health Site
- St. Joseph's HC-Parkwood Hosp
- Bruyere Continuing Care
- Kawartha Regional Memory Clinic
- Toronto Memory Program (Neurology Research Inc.)
- Clinique Neuro Rive-Sud
- Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
- CHAUQ Hopital Enfant-Jesus
- McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
- Groupe Hospitalier Pellegrin
- Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
- Chu Limoges
- Hopital Nord Laennec
- Hopital de Cimiez
- Hopital Broca
- CHU de Rouen Hopital; Service de Neurologie
- Hopital Hautepierre; Centre dInvestigation Clinique
- Hôpital Casselardit; Cons memoire
- Studienambulanz emovis GmbH; St. Joseph Krankenhaus
- Univ Berlin; Klin fur Psychi & Psycho Charite
- Universitätsklinikum Erlangen; Augenklinik
- Bezirkskrankenhaus Günzburg
- Zentralinstitut fuer Seelische Gesundheit
- Inst fur Stedien zur Psych Ges
- Psych Klin der LMU Muenchen
- Ludwig-Maximilians-Univ.
- Klinikum rechts der Isar der Technischen Universität München
- Villa Sauer, Praxis für; Neurologie und Psychiatrie
- Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
- Hospital General de Catalunya
- Policlinica Guipuzcoa
- Hospital de Cruces; Servicio de Neurologia
- Hospital Perpetuo Socorro
- Hospital Universitari Vall d'Hebron
- Clinica Ruber, 4 planta; Servicio de Neurologia
- Hospital Universitario Virgen de la Macarena;
- The Rice Centre; Royal United Hospital
- West London Research Unit; Brentford Lodge
- Royal Sussex County Hospital, CIRU Level 5
- Glasgow Memory Clinic
- The National Hospital for Neurology & Neurosurgery; Dementia Research Center
- Camden Mews Day Hospital; Camden and Islington
- Southampton General Hospital; Pharmacy
- Moorgreen Hospital; Memory Assessment & Rsch Ctr
- Great Western Hosp.; Kingshill Research Ctr
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Part 1: Subcutaneous cohort exp
Part 2: Intravenous cohort exp
Part 1: Subcutaneous cohort
Part 2: Intravenous cohort
Arm Description
Repeating subcutaneous injection
Repeating intravenous infusion
Outcomes
Primary Outcome Measures
Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score
Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score
Secondary Outcome Measures
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01343966
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 30, 2011 (Actual)
Primary Completion Date
February 28, 2014 (Actual)
Study Completion Date
February 28, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
448 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: Subcutaneous cohort exp
Arm Type
Experimental
Arm Title
Part 2: Intravenous cohort exp
Arm Type
Experimental
Arm Title
Part 1: Subcutaneous cohort
Arm Type
Placebo Comparator
Arm Description
Repeating subcutaneous injection
Arm Title
Part 2: Intravenous cohort
Arm Type
Placebo Comparator
Arm Description
Repeating intravenous infusion
Intervention Type
Drug
Intervention Name(s)
MABT5102A
Intervention Description
Repeating subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
MABT5102A
Intervention Description
Repeating intravenous infusion
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Repeating subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Repeating intravenous infusion
Primary Outcome Measure Information:
Title
Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score
Time Frame
From baseline to Week 73
Title
Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score
Time Frame
From baseline to Week 73
Secondary Outcome Measure Information:
Title
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score
Time Frame
From baseline to Week 73
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Paul, M.D., Ph.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Pharmacology Research Inst
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Univ of CA San Diego; Neurosciences Comp.Alzheimer's
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
USC School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pharmacology Research Inst
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
University of California Davis Medical System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Pacific Research Network - PRN
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Uni of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Neurological Research Inst
City
Santa Monica
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Florida Atlantic University; College of Medicine
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Brain Matters Research, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Miami Jewish Health Systems; Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Collier Neurologic Specialists
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Rush Alzheimer's Disease Cntr.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Alexian Brothers Neurosci Inst
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
IU Healthy Partners Adult Neurology Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Louisiana Research Associates
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Millennium Psychiatric Associates, LLC
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
NeuroCognitive Institute
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Facility Name
Memory Enhancement Center of NJ, Inc.
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Empire Neurology, PC
City
Latham
State/Province
New York
ZIP/Postal Code
12210
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center; Monroe Community Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Facility Name
Investigational Drug Service; Univ of Rochester Medical Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-6520
Country
United States
Facility Name
Neurology & Neuroscience Ctr of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Medical Uni of South Carolina
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Neuroscience Research Associates, Inc.
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Saibal Nandy Professional Corporation
City
Medicine Hat
State/Province
Alberta
ZIP/Postal Code
T1B 4E7
Country
Canada
Facility Name
The Med Arts Health Rsrch Grp
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 3G8
Country
Canada
Facility Name
The Med Arts Health Rsrch Grp
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 5C8
Country
Canada
Facility Name
University of British Columbia Hospital; Division of Neurology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Capitol District Health Authority
City
Halilfax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E1
Country
Canada
Facility Name
Jbn Medical Diagnostic Services Inc.
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Providence Care Centre; Mental Health Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 4X3
Country
Canada
Facility Name
St. Joseph's HC-Parkwood Hosp
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Bruyere Continuing Care
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Facility Name
Kawartha Regional Memory Clinic
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 2P4
Country
Canada
Facility Name
Toronto Memory Program (Neurology Research Inc.)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Clinique Neuro Rive-Sud
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHAUQ Hopital Enfant-Jesus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Name
Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Chu Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Nord Laennec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital de Cimiez
City
Nice
ZIP/Postal Code
06003
Country
France
Facility Name
Hopital Broca
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU de Rouen Hopital; Service de Neurologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hopital Hautepierre; Centre dInvestigation Clinique
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital Casselardit; Cons memoire
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Studienambulanz emovis GmbH; St. Joseph Krankenhaus
City
Berlin
ZIP/Postal Code
10626
Country
Germany
Facility Name
Univ Berlin; Klin fur Psychi & Psycho Charite
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitätsklinikum Erlangen; Augenklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Bezirkskrankenhaus Günzburg
City
Günzburg
ZIP/Postal Code
89312
Country
Germany
Facility Name
Zentralinstitut fuer Seelische Gesundheit
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Facility Name
Inst fur Stedien zur Psych Ges
City
Mannheim
ZIP/Postal Code
68165
Country
Germany
Facility Name
Psych Klin der LMU Muenchen
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Ludwig-Maximilians-Univ.
City
Munchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Villa Sauer, Praxis für; Neurologie und Psychiatrie
City
Siegen
ZIP/Postal Code
57072
Country
Germany
Facility Name
Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Hospital General de Catalunya
City
San Cugat del Valles
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Policlinica Guipuzcoa
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20009
Country
Spain
Facility Name
Hospital de Cruces; Servicio de Neurologia
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Perpetuo Socorro
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Clinica Ruber, 4 planta; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena;
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
The Rice Centre; Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
West London Research Unit; Brentford Lodge
City
Brentford
ZIP/Postal Code
TW8 8DS
Country
United Kingdom
Facility Name
Royal Sussex County Hospital, CIRU Level 5
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Glasgow Memory Clinic
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Facility Name
The National Hospital for Neurology & Neurosurgery; Dementia Research Center
City
London, GT LON
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Camden Mews Day Hospital; Camden and Islington
City
London
ZIP/Postal Code
NW1 9DB
Country
United Kingdom
Facility Name
Southampton General Hospital; Pharmacy
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Moorgreen Hospital; Memory Assessment & Rsch Ctr
City
Southampton
ZIP/Postal Code
SO30 3JB
Country
United Kingdom
Facility Name
Great Western Hosp.; Kingshill Research Ctr
City
Swindon
ZIP/Postal Code
SN3 6BW
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31969177
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.
Results Reference
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Learn more about this trial
A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
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