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

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00739037

Purpose

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.

Condition	Intervention	Phase
Alzheimer Disease	Drug: Placebo Drug: PAZ-417	Phase I

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

This study is the measurement of a 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). [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To measure both amyloid beta peptide 42 (Ab42) and PAZ-417 in both plasma and CSF and assess safety using the results of physical examinations, vital sign measurements, ECGs, cardiac telemetry, standard laboratory tests and collection of AES. [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	August 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator	Drug: Placebo
B: Experimental	Drug: PAZ-417

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

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.
Body mass index in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
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:

Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
Any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
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).
History of thrombotic events.
Presence or history of symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris, significant cardiac arrhythmia, or seizures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739037

Locations

United States, California
California Clinical Trials
Glendale, California, United States, 91026

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3186A1-1103
Study First Received:	August 15, 2008
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00739037 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on September 11, 2009