A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: MABT5102A
* Drug: MABT5102A
* Drug: placebo
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Subcutaneous cohort exp<br> | Drug: MABT5102A<br>* Repeating subcutaneous injection<br>|
| Experimental: Part 2: Intravenous cohort exp<br> | Drug: MABT5102A<br>* Repeating intravenous infusion<br>|
| Placebo Comparator: Part 1: Subcutaneous cohort<br>Repeating subcutaneous injection | Drug: placebo<br>* Repeating subcutaneous injection<br>|
| Placebo Comparator: Part 2: Intravenous cohort<br>Repeating intravenous infusion | Drug: placebo<br>* Repeating intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score |  | From baseline to Week 73 | 
| Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score |  | From baseline to Week 73 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score |  | From baseline to Week 73 |