A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 80
Updated:8/3/2016
Start Date:August 2011
End Date:April 2014

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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

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.


Inclusion Criteria:

- Diagnosis of probable AD according to the NINCDS-ADRDA criteria

- MMSE score of 18-26 points at screening

- 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:

- 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
We found this trial at
23
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Fresno, CA
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Decatur, GA
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East Providence, Rhode Island 02915
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Eatontown, NJ
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Elk Grove Village, Illinois 60007
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Fort Myers, FL
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Hallandale Beach, Florida 33009
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Hattiesburg, MS
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Jenkintown, PA
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Nancy,
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Palo Alto, CA
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Providence, RI
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Santa Rosa, CA
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Sun City, AZ
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Toledo, OH
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Tucson, AZ
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