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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: MABT5102A; Drug: placebo

• Registration Number: NCT01343966
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Study Start: 2011-04-30
• Primary Completion: 2014-02-28
• Study Completion: 2014-02-28
• Disposition First Submitted: 2016-08-10
• Disposition First Submitted QC: 2016-08-10
• Disposition First Posted: 2016-08-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1: Subcutaneous cohort exp	MABT5102A	-
Part 2: Intravenous cohort	placebo	Repeating intravenous infusion
Part 2: Intravenous cohort exp	MABT5102A	-
Part 1: Subcutaneous cohort	placebo	Repeating subcutaneous injection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score	From baseline to Week 73

Trial Locations

Locations (90)

Hope Research Institute; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

Pharmacology Research Inst; 🇺🇸 Newport Beach, California, United States

Margolin Brain Institute; 🇺🇸 Fresno, California, United States

Univ of CA San Diego; Neurosciences Comp.Alzheimer's; 🇺🇸 La Jolla, California, United States

USC School of Medicine; 🇺🇸 Los Angeles, California, United States

University of California Davis Medical System; 🇺🇸 Sacramento, California, United States

Pacific Research Network - PRN; 🇺🇸 San Diego, California, United States

Uni of California San Francisco; 🇺🇸 San Francisco, California, United States

Neurological Research Inst; 🇺🇸 Santa Monica, California, United States

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