Trial record 2 of 8 for:    PF-04360365

Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00722046
First received: July 23, 2008
Last updated: October 8, 2012
Last verified: October 2012

July 23, 2008
October 8, 2012
December 2008
August 2011   (final data collection date for primary outcome measure)
  • Safety/tolerability of PF-04360365 in subjects with mild to moderate Alzheimer's disease dosed for 18 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, cognitive assessments) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics of PF-04360365 following administration of multiple doses in subjects with mild to moderate Alzheimer's disease. (plasma and cerebrospinal fluid (as available) PF-04360365 concentrations) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00722046 on ClinicalTrials.gov Archive Site
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma/CSF Abeta; CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; Immunogenicity (anti-drug antibodies) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma/CSF Abeta; CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; Immunogenicity (anti-drug antibodies) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
A Phase 2 Multicenter, Randomized, Double Blind, Placebo-Controlled Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease

Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient 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 0.1 mg/kg
    0.1 mg/kg every 60 days (10 doses total)
  • Biological: PF-04360365 0.5 mg/kg
    0.5 mg/kg every 60 days (10 doses total)
  • Biological: PF-04360365 1 mg/kg
    1 mg/kg every 60 days (10 doses total)
  • Drug: Placebo
    Placebo every 60 days (10 doses total)
  • Biological: PF-04360365 3 mg/kg
    3 mg/kg every 60 days (10 doses total)
  • Biological: PF-04360365 8.5 mg/kg
    8.5 mg/kg every 60 days (10 doses total)
  • Experimental: PF-04360365 0.1 mg/kg
    Intervention: Biological: PF-04360365 0.1 mg/kg
  • Experimental: PF-04360365 0.5 mg/kg
    Intervention: Biological: PF-04360365 0.5 mg/kg
  • Experimental: PF-04360365 1 mg/kg
    Intervention: Biological: PF-04360365 1 mg/kg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-04360365 3 mg/kg
    Intervention: Biological: PF-04360365 3 mg/kg
  • Experimental: PF-04360365 8.5 mg/kg
    Intervention: Biological: PF-04360365 8.5 mg/kg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
August 2011
August 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 criterial 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
Canada,   United States,   Australia,   Belgium,   United Kingdom,   Korea, Republic of
 
NCT00722046
A9951002
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

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