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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Biological: PF-04360365 0.1 mg/kg
Biological: PF-04360365 0.5 mg/kg
Biological: PF-04360365 1 mg/kg
Drug: Placebo
Biological: PF-04360365 3 mg/kg
Biological: PF-04360365 8.5 mg/kg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 198
Study Start Date: December 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04360365 0.1 mg/kg Biological: PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
Experimental: PF-04360365 0.5 mg/kg Biological: PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)
Experimental: PF-04360365 1 mg/kg Biological: PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
Placebo Comparator: Placebo Drug: Placebo
Placebo every 60 days (10 doses total)
Experimental: PF-04360365 3 mg/kg Biological: PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
Experimental: PF-04360365 8.5 mg/kg Biological: PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722046

  Show 38 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00722046     History of Changes
Other Study ID Numbers: A9951002
Study First Received: July 23, 2008
Last Updated: October 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Alzheimer's disease
antibody
amyloid

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014