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Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AN-1792 also known as AIP-001
Sponsored by
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's, AN-1792, AIP-001

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Mild to moderate Alzheimer's disease. Ability to cooperate with MRI scanning and neuropsychological testing. Live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.

Sites / Locations

  • Pivotal Research Centers
  • 21st Century Neurology
  • California Clinical Trials
  • UCSD Medical Center
  • Pharmacology Research Institute
  • Baumel-Eisner Neuromedical Institute
  • Baumel-Eisner Neuromedical Institute
  • Baumel-Eisner Neuromedical Institute
  • Mayo Clinic
  • Clinical Pharmaceutical Trials, Inc.
  • Baylor College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 2, 2001
Last Updated
September 22, 2009
Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00021723
Brief Title
Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2001
Overall Recruitment Status
Terminated
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's disease.
Detailed Description
The study will enroll approximately 375 patients with mild to moderate Alzheimer's disease at investigational sites in the United States and Europe. Patients will receive either AN-1792 or placebo, and they will be evaluated using standard clinical assessments of cognition and memory as well as experimental surrogate markers of Alzheimer's disease pathology. The goal of the study is to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the A-beta peptide in patients with Alzheimer's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's, AN-1792, AIP-001

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
375 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
AN-1792 also known as AIP-001

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Mild to moderate Alzheimer's disease. Ability to cooperate with MRI scanning and neuropsychological testing. Live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.
Facility Information:
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
California Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Pharmacology Research Institute
City
Northridge
State/Province
California
ZIP/Postal Code
91324-4625
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute
City
Bay Harbor Islands
State/Province
Florida
ZIP/Postal Code
33154
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Clinical Pharmaceutical Trials, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease

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