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A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00945672
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : May 5, 2016
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE July 22, 2009
First Posted Date  ICMJE July 24, 2009
Last Update Posted Date May 5, 2016
Study Start Date  ICMJE August 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2009)
  • Safety/tolerability/PK of multiple doses of PF-04360365 in subjects with mild to moderate Alzheimer's disease dosed for 1 year (adverse events, physical/neurological exams, vital signs, 12-lead ECG, clinical labs, brain MRI, cognitive assessments) [ Time Frame: 18 months ]
  • Brain amyloid burden [ Time Frame: 13 months ]
  • CSF abeta [ Time Frame: 13 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2009)
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma abeta, CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; immunogenicity (anti-drug antibodies) [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE A Phase 2 Double-Blinded, Randomized, Placebo-Controlled, Multicenter Study Evaluating The Safety, Tolerability And Pharmacokinetics/ Pharmacodynamics Of PF-04360365 In Mild To Moderate Alzheimer's Disease Patients
Brief Summary The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Biological: PF-04360365 10 mg/kg
    10 mg/kg every 90 days (5 total doses)
  • Biological: PF-04360365 7.5 mg/kg
    10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses)
  • Drug: placebo
    placebo administered every 90 days or monthly to match experimental treatment arms.
Study Arms  ICMJE
  • Experimental: PF-04360365 10 mg/kg
    Intervention: Biological: PF-04360365 10 mg/kg
  • Experimental: PF-04360365 7.5 mg/kg
    Intervention: Biological: PF-04360365 7.5 mg/kg
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   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: July 23, 2009)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females of non childbearing potential, age > or = 50.
  • Diagnosis of probable Alzheimer's disease, consistent with criteria from both:

    • National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
    • Diagnostic and Statistical Manual of Mental Disorders (DSM IV).
  • Mini-mental status exam score of 16-26 inclusive.
  • Rosen-Modified Hachinski Ischemia Score of < or = 4.

Exclusion Criteria:

  • Diagnosis or history of other demential or neurodegenerative disorders.
  • Diagnosis or history of clinically significant cerebrovascular disease.
  • Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities.
  • History of autoimmune disorders.
  • History of allergic or anaphylactic reactions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (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 Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00945672
Other Study ID Numbers  ICMJE A9951007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP