Back to resultsSafety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AAB-001
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Caregivers, Alzheimer disease
Eligibility Criteria
Inclusion Criteria: Diagnosis of probable AD Age from 50 to 85 years, inclusive Rosen Modified Hachinski ischemic score less than or equal to 4 Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of AD Fluency in English Stable doses of medications Exclusion Criteria: Significant neurological disease other than AD Major psychiatric disorder Significant systemic illness History of stroke or seizure Weight greater than 120kg (264 lbs.) History of autoimmune disease Smoking more than 20 cigarettes per day Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications Prior treatment with experimental immunotherapeutics or vaccines for AD Presence of pacemakers or foreign metal objects in the eyes, skin, or body
Sites / Locations
- Pharmacology Research Institute
- Pharmacology Research Institute
Outcomes
Primary Outcome Measures
Safety assessments
Secondary Outcome Measures
Blood levels of administered study drug
Cognitive and functional assessments
Full Information
NCT ID
NCT00174525
First Posted
September 9, 2005
Last Updated
May 8, 2012
Sponsor
Pharmacology Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00174525
Brief Title
Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease
Official Title
A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pharmacology Research Institute
4. Oversight
5. Study Description
Brief Summary
This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.
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 Caregivers, Alzheimer disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AAB-001
Primary Outcome Measure Information:
Title
Safety assessments
Secondary Outcome Measure Information:
Title
Blood levels of administered study drug
Title
Cognitive and functional assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Eligibility Criteria
Inclusion Criteria:
Diagnosis of probable AD
Age from 50 to 85 years, inclusive
Rosen Modified Hachinski ischemic score less than or equal to 4
Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of AD
Fluency in English
Stable doses of medications
Exclusion Criteria:
Significant neurological disease other than AD
Major psychiatric disorder
Significant systemic illness
History of stroke or seizure
Weight greater than 120kg (264 lbs.)
History of autoimmune disease
Smoking more than 20 cigarettes per day
Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
Prior treatment with experimental immunotherapeutics or vaccines for AD
Presence of pacemakers or foreign metal objects in the eyes, skin, or body
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel E. Grosz, MD
Organizational Affiliation
Pharmacology Research Institute, Northridge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute
City
Northridge
State/Province
California
ZIP/Postal Code
91324-4625
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease
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