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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01254773
First received: December 3, 2010
Last updated: April 21, 2014
Last verified: April 2014

December 3, 2010
April 21, 2014
December 2010
January 2013   (final data collection date for primary outcome measure)
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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01254773 on ClinicalTrials.gov Archive Site
  • To assess the safety of bapineuzumab administered SC at monthly intervals compared to placebo in subjects with mild to moderate AD [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Experimental Bapineuzumab
Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
  • Experimental: Bapineuzumab SC Dose 1; 2 mg
    Intervention: Drug: Experimental Bapineuzumab
  • Experimental: Bapineuzumab SC Dose 2; 7 mg
    Intervention: Drug: Experimental Bapineuzumab
  • Experimental: Bapineuzumab SC Dose 3; 20 mg
    Intervention: Drug: Experimental Bapineuzumab
  • Placebo Comparator: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
March 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01254773
AAB-001-SC-ALZ-2003
Yes
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
Not Provided
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP