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Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01005862
First received: October 30, 2009
Last updated: September 25, 2012
Last verified: September 2012

October 30, 2009
September 25, 2012
March 2010
September 2012   (final data collection date for primary outcome measure)
Fractional Clearance rate of ABeta peptide in CSF [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01005862 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • PF-04360365 concentrations and ABETA concentrations in plasma and CSF [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • PF-04360365 concentrations and ABETA concentrations in plasma and CSF [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, MRI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: PF-04360365
    10 mg/kg, single dose administered intravenously
  • Drug: Placebo
    Placebo
  • Experimental: PF-04360365
    Intervention: Biological: PF-04360365
  • Placebo Comparator: Placebo
    single dose administered intravenously
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Sweden
 
NCT01005862
A9951011
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

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