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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00945672
First Posted: July 24, 2009
Last Update Posted: May 5, 2016
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.
Information provided by:
Pfizer
July 22, 2009
July 24, 2009
May 5, 2016
August 2009
June 2011   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00945672 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2011
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00945672
A9951007
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

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