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Trial record 1 of 1 for:    NCT01005862
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Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01005862
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : September 26, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 30, 2009
First Posted Date  ICMJE November 2, 2009
Last Update Posted Date September 26, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2009)
Fractional Clearance rate of ABeta peptide in CSF [ Time Frame: 36 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01005862 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
  • Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion [ Time Frame: 36 hours ]
  • PF-04360365 concentrations and ABETA concentrations in plasma and CSF [ Time Frame: 36 hours ]
  • Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration [ Time Frame: 36 hours ]
  • Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2009)
  • Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion [ Time Frame: 36 hours ]
  • PF-04360365 concentrations and ABETA concentrations in plasma and CSF [ Time Frame: 36 hours ]
  • Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration [ Time Frame: 36 hours ]
  • Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, MRI [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
Official Title  ICMJE A Randomized, Investigator And Subject-Blind, Sponsor-Open, Placebo-Controlled Study To Examine The Effects Of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
Brief Summary The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.
Detailed Description Not 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
    10 mg/kg, single dose administered intravenously
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: PF-04360365
    Intervention: Biological: PF-04360365
  • Placebo Comparator: Placebo
    single dose administered intravenously
    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: September 25, 2012)
17
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2009)
18
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females of non-childbearing potential (age 50 and over for Alzheimer's disease patients; 21-45 for healthy volunteers)
  • For patients with Alzheimer's Disease: 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) and Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
  • Mini-mental status exam score greater than or equal to 20
  • Rosen-Modified Hachinski Ischemia Score of < or = 4
  • On stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01005862
Other Study ID Numbers  ICMJE A9951011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2012

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