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Multiple Dose Study Evaluating the Safety and Tolerability of NSA-789

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ClinicalTrials.gov Identifier: NCT00795730
Recruitment Status : Terminated
First Posted : November 21, 2008
Last Update Posted : July 21, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with Alzheimer's Disease

Condition or disease Intervention/treatment Phase
Alzheimer Disease Healthy Subjects Drug: NSA-789 Other: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects and Subjects With Alzheimer's Disease
Study Start Date : January 2009
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo Other: placebo
Experimental: NSA-789 Drug: NSA-789



Primary Outcome Measures :
  1. Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pharmacokinetic and pharmcodynamic parameters [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with Alzheimer's Disease)
  • Women must be surgically sterile or postmenopausal
  • Subjects with Alzheimer's Disease must be generally healthy, but may have a stable, chronic illness if well controlled.

Exclusion Criteria

  • Healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study.
  • Subjects with Alzheimer's Disease may not be on any cholinesterase inhibitors such as donepezil (Aricept®) or rivastigmine (Exelon®) within 4 weeks of the start of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795730


Locations
United States, California
Glendale, California, United States, 91206
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00795730     History of Changes
Other Study ID Numbers: 3230A1-1002
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: July 21, 2009
Last Verified: July 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Alzheimer's Disease
schizophrenia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders