Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease (SUMMIT AD)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Experimental Bapineuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254773

AAB-001-SC-ALZ-2003

Details and patient eligibility

About

This study in individuals with mild to moderate Alzheimer's Disease is designed to assess:(1) safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

Enrollment: 146 patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of probable AD
• Age from 50 to less than 89
• Mini-Mental Status Exam score of 18-26 inclusive
• Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
• Stable doses of medications (cholinesterase inhibitors and memantine allowed)
• Caregiver able to attend all clinic visits with patient
• Amyloid burden on screening PET scan consistent with diagnosis of AD

Exclusion criteria

• Significant neurological disease other than AD
• Major psychiatric disorder
• Significant systemic illness
• History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
• Smoking greater than 20 cigarettes per day
• Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
• Prior treatment experimental immunotherapeutics or vaccines for AD
• Women of childbearing potential
• Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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146 participants in 4 patient groups, including a placebo group

Bapineuzumab SC Dose 1; 2 mg

Experimental group

Treatment:

Drug: Experimental Bapineuzumab

Bapineuzumab SC Dose 2; 7 mg

Experimental group

Treatment:

Drug: Experimental Bapineuzumab

Bapineuzumab SC Dose 3; 20 mg

Experimental group

Treatment:

Drug: Experimental Bapineuzumab

Placebo

Placebo Comparator group