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
  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

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Peoria, Arizona, United States, 85381
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33176
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Illinois
Pfizer Investigational Site
Elk Grove Village, Illinois, United States, 60007
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66209
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, New Jersey
Pfizer Investigational Site
Eatontown, New Jersey, United States, 07724
Pfizer Investigational Site
Oakhurst, New Jersey, United States, 07755
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States, 02906
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Pfizer Investigational Site
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Pfizer Investigational Site
Heidelberg West, Victoria, Australia, 3084
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Belgium
Pfizer Investigational Site
Antwerpen, Belgium, 2020
Pfizer Investigational Site
Edegem, Belgium, 2650
Pfizer Investigational Site
Jette, Belgium, 1090
Pfizer Investigational Site
Leuven, Belgium, 3000
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6C 5J1
Pfizer Investigational Site
Peterborough, Ontario, Canada, K9H 2P4
Pfizer Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, Canada, M3B 2S7
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H1T 2M4
Pfizer Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Korea, Republic of
Pfizer Investigational Site
Sungnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 136-705
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 143-914
Pfizer Investigational Site
Seoul, Korea, Republic of, 133-792
United Kingdom
Pfizer Investigational Site
Trafford Park, Manchester, United Kingdom, M32 0UT
Pfizer Investigational Site
Swindon, Wiltshire, United Kingdom, SN3 6BB
Pfizer Investigational Site
Swindon, Wiltshire, United Kingdom, SN3 6BW
Pfizer Investigational Site
Manchester, United Kingdom, M32 0UT
Pfizer Investigational Site
Southampton, United Kingdom, SO16 6YD
Pfizer Investigational Site
Southampton, United Kingdom, SO30 3JB
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 September 14, 2014