Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease
NCT01193608
ABOUT THIS STUDY
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1-800-718-1021
- 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
- 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
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Descriptive Information | ||||
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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 |