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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: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: Experimental Bapineuzumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 146
Study Start Date: December 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bapineuzumab SC Dose 1 Drug: Experimental Bapineuzumab
Comparisons of 3 different doses of Bapineuzumab or placebo, given Subcutaneously (under the skin) monthly for 24 months.
Experimental: Bapineuzumab SC Dose 2 Drug: Experimental Bapineuzumab
Comparisons of 3 different doses of Bapineuzumab or placebo, given Subcutaneously (under the skin) monthly for 24 months.
Experimental: Bapineuzumab SC Dose 3 Drug: Experimental Bapineuzumab
Comparisons of 3 different doses of Bapineuzumab or placebo, given Subcutaneously (under the skin) monthly for 24 months.
No Intervention: Placebo

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254773

  Show 28 Study Locations
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
  More Information

No publications provided

Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01254773     History of Changes
Other Study ID Numbers: AAB-001-SC-ALZ-2003
Study First Received: December 3, 2010
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013