Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease
NCT01193608
Last updated date
ABOUT THIS STUDY
This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients
with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812)
or placebo. Each patient's participation will last approximately 41 weeks.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
50-89 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease
- Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
- Caregiver will participate and be able to attend clinic visits with patient
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Significant neurological disease other than Alzheimer's Disease
- Major psychiatric disorder
- Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal
objects in the body)
- Women of childbearing potential
NEED INFO?
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812) or placebo. Each patient's participation will last approximately 41 weeks. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Alzheimer's Disease | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 88 | |||
| Original Estimated Enrollment ICMJE | 80 | |||
| Actual Study Completion Date ICMJE | October 2013 | |||
| Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 50 Years to 89 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Korea, Republic of, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01193608 | |||
| Other Study ID Numbers ICMJE | B2601001 3245K1-1000 ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | JANSSEN Alzheimer Immunotherapy Research & Development, LLC | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||