Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112073
Status:
COMPLETED
Last Update Posted:
2012-03-14
First Post:
2005-05-27
Brief Title:
AAB-001 in Patients With Mild to Moderate Alzheimers Disease
Sponsor:
JANSSEN Alzheimer Immunotherapy Research Development LLC
Organization:
JANSSEN Alzheimer Immunotherapy Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimers disease AD
Detailed Description:
The humanized monoclonal antibody AAB-001 which binds to and clears beta amyloid peptide is designed to provide antibodies to beta amyloid directly to the patient rather than requiring the patient to mount hisher own individual response It is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid Animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods
This is a multicenter double-blind placebo controlled randomized outpatient multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD Approximately 30 study sites will be involved Patients will be randomized to receive either AAB-001 or placebo Each patients participation will last approximately 2 years
This is a multicenter double-blind placebo controlled randomized outpatient multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD Approximately 30 study sites will be involved Patients will be randomized to receive either AAB-001 or placebo Each patients participation will last approximately 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None