A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
NCT ID: NCT01397578
Last Updated: 2017-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2011-08-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1: Subcutaneous cohort exp
MABT5102A
Repeating subcutaneous injection
Part 2: Intravenous cohort exp
MABT5102A
Repeating intravenous infusion
Part 1: Subcutaneous cohort
Repeating subcutaneous injection
placebo
Repeating subcutaneous injection
Part 2: Intravenous cohort
Repeating intravenous injection
placebo
Repeating intravenous infusion
Interventions
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MABT5102A
Repeating subcutaneous injection
MABT5102A
Repeating intravenous infusion
placebo
Repeating subcutaneous injection
placebo
Repeating intravenous infusion
Eligibility Criteria
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Inclusion 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)
* 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
Exclusion Criteria
* 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
50 Years
80 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Paul, M.D., Ph.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Banner Sun Health Research Insitute
Sun City, Arizona, United States
NNS Clinical Research LLC
Tucson, Arizona, United States
Margolin Brain Institute
Fresno, California, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
Pacific Neuroscience Med Grp
Oxnard, California, United States
Stanford Univ Medical Center
Palo Alto, California, United States
Redwood Regional Medical Group
Santa Rosa, California, United States
Internal Med Assoc of Lee Cty
Fort Myers, Florida, United States
Neuropsychiatric Research; Center of Southwest Florida
Fort Myers, Florida, United States
MD Clinical
Hallandale, Florida, United States
Compass Research
Orlando, Florida, United States
Dekalb Neurology Associates
Decatur, Georgia, United States
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
Manhasset, New York, United States
Neurology & Neuroscience Ctr of Ohio
Toledo, Ohio, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
Hopital Central-CHU de Nancy; Pharmacie
Nancy, , France
Hôpital Casselardit; Cons memoire
Toulouse, , France
Clinique Psychiatrique Univ
Tours, , France
Fundació ACE
BArcelon, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Mutua De Terrasa
Barcelona, , Spain
Countries
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References
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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.
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.
Salloway 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.
Other Identifiers
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GN00762
Identifier Type: OTHER
Identifier Source: secondary_id
ABE4955g
Identifier Type: -
Identifier Source: org_study_id
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