Study Evaluating PAZ-417 in Cerebrospinal Fluid in Subjects With Alzheimer's Disease
NCT00739037
Last updated date
ABOUT THIS STUDY
The primary purpose of this study is to assess biomarker known as amyloid beta peptide 40
(Ab40) in Cerebrospinal Fluid (CSF), following a single oral dose of PAZ-417 in subjects with
Alzheimer Disease (AD). This study will also consider another biomarker amyloid beta peptide
42 (Ab42) in Cerebrospinal Fluid in subjects with Alzheimer Disease and assess the safety,
tolerability and pharmacokinetic profile of PAZ-417 in both plasma and Cerebrospinal Fluid in
these subjects.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Alzheimer Disease
Sex
Females and Males
Age
55 + years
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating PAZ-417 in Cerebrospinal Fluid in Subjects With Alzheimer's Disease | |||
Official Title ICMJE | A Randomized, Single Dose, Placebo-Controlled, 2 Period Crossover Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAZ 417 in Cerebrospinal Fluid, When Administered Orally to Subjects With Alzheimer's Disease | |||
Brief Summary | The primary purpose of this study is to assess biomarker known as amyloid beta peptide 40 (Ab40) in Cerebrospinal Fluid (CSF), following a single oral dose of PAZ-417 in subjects with Alzheimer Disease (AD). This study will also consider another biomarker amyloid beta peptide 42 (Ab42) in Cerebrospinal Fluid in subjects with Alzheimer Disease and assess the safety, tolerability and pharmacokinetic profile of PAZ-417 in both plasma and Cerebrospinal Fluid in these subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Triple (Participant, Care Provider, Investigator) | |||
Condition ICMJE | Alzheimer Disease | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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 | Terminated | |||
Estimated Enrollment ICMJE | 10 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2008 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion:
Exclusion:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 55 Years and older (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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00739037 | |||
Other Study ID Numbers ICMJE | 3186A1-1103 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | August 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |