NCT01254773|CompletedPhase 2DMC

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

SUMMIT AD

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

JANSSEN Alzheimer Immunotherapy Research & Development, LLC ClinicalTrials.gov

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1 other identifier

AAB-001-SC-ALZ-2003

Study Type

interventional

Target

146

Locations

1 country

Sites

Timeline

RegisteredDec 2010

StartedDec 2010

CompletionMar 2013

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

146

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2010

Geographic Reach

1 country

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Start

First participant enrolled

December 1, 2010

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed

Last Updated

May 9, 2014

Status Verified

April 1, 2014

Enrollment Period

2.1 years

First QC Date

December 3, 2010

Last Update Submit

April 21, 2014

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

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

Study Arms (4)

Bapineuzumab SC Dose 1; 2 mg

EXPERIMENTAL

Drug: Experimental Bapineuzumab

Bapineuzumab SC Dose 2; 7 mg

EXPERIMENTAL

Drug: Experimental Bapineuzumab

Bapineuzumab SC Dose 3; 20 mg

EXPERIMENTAL

Drug: Experimental Bapineuzumab

Placebo

PLACEBO COMPARATOR

Interventions

Experimental BapineuzumabDRUG

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

Bapineuzumab SC Dose 1; 2 mgBapineuzumab SC Dose 2; 7 mgBapineuzumab SC Dose 3; 20 mg

Eligibility Criteria

Age50 Years - 89 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.