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Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease

Last updated on November 13, 2019

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Study Location
MD Clinical
Hallandale Beach, Florida, 33009 United States
Contact
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
50-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Successful completion of study B2601001

- MMSE 12 or greater

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Study B2601001 Week 32 MRI with clinically important exclusionary findings.

- Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001

NCT01369225
Pfizer
Completed
Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease

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Descriptive Information
Brief Title  ICMJE Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE A Multicenter, Open-label Extension, Multiple Dose, Parallel Group Study To Investigate The Long-term Safety And Tolerability Of Aab-003 (Pf-05236812) Administered Intravenously In Subjects With Mild To Moderate Alzheimer's Disease Previously Treated With Aab-003 Or Placebo In Protocol B2601001
Brief SummaryThis is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: AAB-003 (PF-05236812)
    0.5 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    1 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    2 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    4 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    8 mg/kg AAB-003, IV
Study Arms  ICMJE
  • Experimental: 0.5 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 1 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 2 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 4 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 8 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
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
 (submitted: September 26, 2014)
52
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2011)
104
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion DateAugust 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Successful completion of study B2601001
  • MMSE 12 or greater

Exclusion Criteria:

  • Study B2601001 Week 32 MRI with clinically important exclusionary findings.
  • Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 90 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 NCT01369225
Other Study ID Numbers  ICMJE B2601003
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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