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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center, Biomarker, Safety, and Pharmacokinetic Study of Bapineuzumab (AAB-001) Administered Subcutaneously at Monthly Intervals in Subjects With Mild to Moderate Alzheimer's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01254773

Acronym

SUMMIT AD

Enrollment

146

Registered

2010-12-07

Start date

2010-12-31

Completion date

2013-03-31

Last updated

2014-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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.

Interventions

DRUGExperimental Bapineuzumab

Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 89 Years

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

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of bapineuzumab administered subcutaneously (SC) at monthly intervals compared to placebo on cerebral amyloid burden in subjects with mild to moderate AD.	24 months

Secondary

Measure	Time frame
To assess the safety of bapineuzumab administered SC at monthly intervals compared to placebo in subjects with mild to moderate AD	24 months
To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints.	24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026