A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
This study is currently recruiting participants.
Verified December 2012 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01397578
First received: July 18, 2011
Last updated: December 5, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: MABT5102A Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Genentech:
Primary Outcome Measures:
- Change in brain amyloid load as assessed by amyloid PET imaging [ Time Frame: Baseline to Week 69 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease [ Time Frame: Baseline to Week 69 ] [ Designated as safety issue: No ]
- Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging [ Time Frame: Baseline to Week 69 ] [ Designated as safety issue: No ]
- Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score [ Time Frame: Baseline to Week 73 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 72 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: MABT5102A
Repeating subcutaneous injection
Drug: placebo
Repeating subcutaneous injection
|
| Experimental: B |
Drug: MABT5102A
Repeating intravenous infusion
Drug: placebo
Repeating intravenous infusion
|
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397578
Show 30 Study Locations
Contacts
| Contact: Please reference Study ID Number: ABE4955g www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Show 30 Study LocationsSponsors and Collaborators
Genentech
Investigators
| Study Director: | Robert Paul, M.D., Ph.D. | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01397578 History of Changes |
| Other Study ID Numbers: | ABE4955g, GN00762 |
| Study First Received: | July 18, 2011 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013