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

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00795730
First received: November 20, 2008
Last updated: July 20, 2009
Last verified: July 2009
History of Changes

November 20, 2008
July 20, 2009
January 2009
June 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00795730 on ClinicalTrials.gov Archive Site
Pharmacokinetic and pharmcodynamic parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multiple Dose Study Evaluating the Safety and Tolerability of NSA-789
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

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Healthy Subjects
  • Drug: NSA-789
  • Other: placebo
  • Placebo Comparator: placebo
    Intervention: Other: placebo
  • Experimental: NSA-789
    Intervention: Drug: NSA-789
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
56
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00795730
3230A1-1002
No
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
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP