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

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NCT01005862

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Glendale, California, 91206 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
21+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- On stable dose of background cholinesterase inhibitor or memantine at least 3 months
prior to enrollment

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

- 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

NCT01005862
Pfizer
Completed
Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers

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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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden,   United States
 
 
NCT01005862
A9951011
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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