AAB-003 (PF-05236812) in Alzheimer's Disease
AAB-003 (PF-05236812) in Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
This Phase I study will evaluate the safety of the experimental drug AAB-003 (PF-05236812) in people with mild to moderate Alzheimer's disease. Participants will receive one of five doses of AAB-003 or a placebo. Participation will last approximately 41 weeks.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 89 Years | Both | No |
Inclusion Criteria:
- Diagnosis of probable Alzheimer's dsease (MMSE score of 16-26 and brain MRI consistent with Alzheimer's)
- Use of cholinesterase inhibitor or memantine allowed, if stable
- Availability of caregiver to attend clinic visits with participant
Exclusion Criteria:
- Significant neurological disease other than Alzheimer's disease
- Major psychiatric disorder
- Contraindication to brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
- Women of childbearing potential
Detailed Description:
None given.
Central Contact Information:
For more information about this clinical trial, please contact the Pfizer CT.gov Call Center at 1-800-718-1021.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 33.090285, -117.0499859 | Escondido | California | 92025 | Name: Phone: | ||
Geolocation is 25.9812024, -80.148379 | Hallandale Beach | Florida | 33009 | Name: Phone: | ||
Geolocation is 29.1571921, -82.1223977 | Ocala | Florida | 34471 | Name: Phone: | ||
Geolocation is 29.1259294, -82.2800546 | Ocala | Florida | 34481 | Name: Phone: | ||
Geolocation is 33.7717008, -84.3726049 | Atlanta | Georgia | 30308 | Name: Phone: | ||
Geolocation is 39.0038878, -77.1053673 | Bethesda | Maryland | 20814 | Name: Phone: | ||
Geolocation is 39.0839973, -77.1527578 | Rockville | Maryland | 20850 | Name: Phone: | ||
Geolocation is 42.2917069, -85.5872286 | Kalamazoo | Michigan | 49048 | Name: Phone: | ||
Geolocation is 32.3095903, -90.1389757 | Flowood | Mississippi | 39232 | Name: Phone: | ||
Geolocation is 38.6608855, -90.422618 | Creve Coeur | Missouri | 63141 | Name: Phone: | ||
Geolocation is 38.767401, -90.4408037 | St. Louis | Missouri | 63044 | Name: Phone: | ||
Geolocation is 40.2962222, -74.0509725 | Eatontown | New Jersey | 07724 | Name: Phone: | ||
Geolocation is 40.5230137, -74.3411515 | Edison | New Jersey | 08837 | Name: Phone: | ||
Geolocation is 40.2613515, -74.023593 | Oakhurst | New Jersey | 07755 | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
Pfizer |
Collaborator Sponsor:
| Agency |
|---|
JANSSEN Alzheimer Immunotherapy Research & Development, LLC |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Pfizer CT.gov Call Center | Study Director | Pfizer |
Study Contact:
| Name | Phone |
|---|---|
Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
ClinicalTrials.gov ID
NCT01193608 (follow link to view full record on ct.gov in new window)
Official Title:
A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive, Multiple Ascending Dose Study Of The Safety, Tolerability And Pharmacokinetics Of AAB-003 (PF-05236812) In Subjects With Mild To Moderate Alzheimer's Disease
Study Start Date:
September 2010
Study End Date:
October 2013
Disease Stage:
Early
Middle
Enrollment:
104
