A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
2 other identifiers
interventional
91
3 countries
29
Brief Summary
This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2011
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedStudy Start
First participant enrolled
August 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2014
CompletedJuly 12, 2017
July 1, 2017
2.7 years
July 18, 2011
July 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in brain amyloid load as assessed by amyloid PET imaging
Baseline to Week 69
Secondary Outcomes (3)
Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease
Baseline to Week 69
Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging
Baseline to Week 69
Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score
Baseline to Week 73
Study Arms (4)
Part 1: Subcutaneous cohort exp
EXPERIMENTALPart 2: Intravenous cohort exp
EXPERIMENTALPart 1: Subcutaneous cohort
PLACEBO COMPARATORRepeating subcutaneous injection
Part 2: Intravenous cohort
PLACEBO COMPARATORRepeating intravenous injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
- For patients currently receiving treatment with approved AD treatments (AChE inhibitors or memantine): Treatment initiated and continued for at least the last 3 months prior to randomization, at a stable dose for at least the last 2 months prior to randomization
You may not qualify if:
- 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 (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation)
- History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (e.g., cerebral contusion)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (29)
Banner Alzheimer's Institute
Phoenix, Arizona, 85020, United States
Banner Sun Health Research Insitute
Sun City, Arizona, 85351, United States
NNS Clinical Research LLC
Tucson, Arizona, 85704, United States
Margolin Brain Institute
Fresno, California, 93720, United States
University of California Los Angeles (UCLA)
Los Angeles, California, 90095, United States
Pacific Neuroscience Med Grp
Oxnard, California, 93030, United States
Stanford Univ Medical Center
Palo Alto, California, 94304, United States
Redwood Regional Medical Group
Santa Rosa, California, 95403, United States
Internal Med Assoc of Lee Cty
Fort Myers, Florida, 33912, United States
Neuropsychiatric Research; Center of Southwest Florida
Fort Myers, Florida, 33912, United States
MD Clinical
Hallandale, Florida, 33009, United States
Compass Research
Orlando, Florida, 32806, United States
Dekalb Neurology Associates
Decatur, Georgia, 30033, United States
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, 60007, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, 89106, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
Manhasset, New York, 11030, United States
Neurology & Neuroscience Ctr of Ohio
Toledo, Ohio, 43623, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Hopital Central-CHU de Nancy; Pharmacie
Nancy, 54035, France
Hôpital Casselardit; Cons memoire
Toulouse, 31059, France
Clinique Psychiatrique Univ
Tours, 37044, France
Fundació ACE
BArcelon, Barcelona, 08034, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Mutua De Terrasa
Barcelona, 08221, Spain
Related Publications (3)
Polhamus DG, Dolton MJ, Rogers JA, Honigberg L, Jin JY, Quartino A. Longitudinal Exposure-Response Modeling of Multiple Indicators of Alzheimer's Disease Progression. J Prev Alzheimers Dis. 2023;10(2):212-222. doi: 10.14283/jpad.2023.13.
PMID: 36946448DERIVEDYoshida 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.
PMID: 31969177DERIVEDSalloway S, Honigberg LA, Cho W, Ward M, Friesenhahn M, Brunstein F, Quartino A, Clayton D, Mortensen D, Bittner T, Ho C, Rabe C, Schauer SP, Wildsmith KR, Fuji RN, Suliman S, Reiman EM, Chen K, Paul R. Amyloid positron emission tomography and cerebrospinal fluid results from a crenezumab anti-amyloid-beta antibody double-blind, placebo-controlled, randomized phase II study in mild-to-moderate Alzheimer's disease (BLAZE). Alzheimers Res Ther. 2018 Sep 19;10(1):96. doi: 10.1186/s13195-018-0424-5.
PMID: 30231896DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Paul, M.D., Ph.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 19, 2011
Study Start
August 31, 2011
Primary Completion
April 30, 2014
Study Completion
April 30, 2014
Last Updated
July 12, 2017
Record last verified: 2017-07