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A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

Last updated on November 16, 2019

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Study Location
Pfizer Investigational Site
Heidelberg West, Victoria, 3081 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or Females of non-childbearing potential, age 50-85

- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1)
National Institute of Neurological and Communicable Disease and Stroke and
Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); and
2)Diagnostic and Statistical Manual of Mental Disorders (DSM IV)

- Mini-mental status exam score of 16-26 inclusive

- Rosen-Modified Hachinski Ischemia Score

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Diagnosis or history of other dementia 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

NCT00455000
Pfizer
Completed
A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

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Descriptive Information
Brief Title  ICMJE A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE A Phase I, Randomized, Placebo Controlled, Double Blind Dose Escalation Study Of The Safety, Tolerability, Pharmacokinetics,Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease
Brief SummaryThe purpose of this study is determine whether a single IV dose of PF-04360365 is safe and well tolerated in Adults with Mild to Moderate Alzheimer's disease.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Biological: PF-04360365
    Monoclonal antibody
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Active treatment
    5 possible active doses
    Intervention: Biological: PF-04360365
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2009)
37
Original Enrollment  ICMJE
 (submitted: March 30, 2007)
36
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion DateSeptember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Females of non-childbearing potential, age 50-85
  • Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); and 2)Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
  • Mini-mental status exam score of 16-26 inclusive
  • Rosen-Modified Hachinski Ischemia Score < or = 4

Exclusion Criteria:

  • Diagnosis or history of other dementia 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Sweden,   United Kingdom
Removed Location CountriesBelgium
 
Administrative Information
NCT Number  ICMJE NCT00455000
Other Study ID Numbers  ICMJE A9951001
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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