A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
This study is currently recruiting participants.
Verified November 2012 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01343966
First received: April 27, 2011
Last updated: November 16, 2012
Last verified: November 2012
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Purpose
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.
| 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 Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY) |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score [ Time Frame: From baseline to Week 73 ] [ Designated as safety issue: No ]
- Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score [ Time Frame: From baseline to Week 73 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score [ Time Frame: From baseline to Week 73 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 372 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 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)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343966
Show 98 Study Locations
Contacts
| Contact: Please reference Study ID Number: ABE4869g www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Show 98 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: | NCT01343966 History of Changes |
| Other Study ID Numbers: | ABE4869g, ABBY, GN00761 |
| Study First Received: | April 27, 2011 |
| Last Updated: | November 16, 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 22, 2013