Trial record 7 of 8 for:    PF-04360365

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00945672
First received: July 22, 2009
Last updated: June 17, 2011
Last verified: June 2011

July 22, 2009
June 17, 2011
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 ] [ Designated as safety issue: No ]
  • Brain amyloid burden [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • CSF abeta [ Time Frame: 13 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00945672
A9951007
Yes
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