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Study Evaluating PAZ-417 in Cerebrospinal Fluid in Subjects With Alzheimer's Disease

Last updated on December 15, 2017

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Study Location
California Clinical Trials
Glendale, California, 91026 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00739037
Pfizer
Terminated
Study Evaluating PAZ-417 in Cerebrospinal Fluid in Subjects With Alzheimer's Disease

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Study Evaluating PAZ-417 in Cerebrospinal Fluid in Subjects With Alzheimer's Disease
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Alzheimer Disease
  • Drug: Placebo
  • Drug: PAZ-417
  • Placebo Comparator: A
    Intervention: Drug: Placebo
  • Experimental: B
    Intervention: Drug: PAZ-417
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
December 2008
December 2008   (Final data collection date for primary outcome measure)

Inclusion:

  1. Men or women of non-childbearing potential, 55 years of age or older with a probable diagnosis of Alzheimer's Disease (AD), according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. Subjects will have AD that is mild to moderate in severity, as qualified by a score of 12 to 26 on the Mini-Mental State Examination (MMSE). Woman of non-childbearing potential must be either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal at least 1 year and must have a negative serum pregnancy test result within 48 hours before administration of test article. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
  2. Body mass index in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
  3. Subjects must be generally healthy, with the exception of AD but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination findings, vital sign measurements, findings on 12 lead electrocardiogram (ECG), or chronic laboratory test results that are associated with stable, well controlled chronic illness.

Exclusion:

  1. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
  2. Any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  3. History of vascular disorders (peripheral, coronary, venous), chronic inflammatory disorders (eg, rheumatoid arthritis), hematologic disorders, or bleeding disorders (eg, hemophilia, idiopathic thrombocytopenic purpura, VonWillebrand disease).
  4. History of thrombotic events.
  5. Presence or history of symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris, significant cardiac arrhythmia, or seizures.
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00739037
3186A1-1103
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the

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

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