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

Genentech

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: MABT5102A; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01343966

GN00761 (Other Identifier)

ABE4869g

ABBY (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 448 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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448 participants in 4 patient groups, including a placebo group

Part 1: Subcutaneous cohort exp

Experimental group

Treatment:

Drug: MABT5102A

Drug: MABT5102A

Part 2: Intravenous cohort exp

Experimental group

Treatment:

Drug: MABT5102A

Drug: MABT5102A

Part 1: Subcutaneous cohort

Placebo Comparator group

Description:

Repeating subcutaneous injection

Treatment:

Drug: placebo

Drug: placebo

Part 2: Intravenous cohort

Placebo Comparator group

Description:

Repeating intravenous infusion

Treatment:

Drug: placebo

Drug: placebo