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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795730
• Other study ID #: 3230A1-1002
• Status: Completed
• Phase: Phase 1
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: August 2021
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Healthy Subjects

Intervention

Drug:
• NSA-789

Other:
• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability		6 months
Secondary	Pharmacokinetic and pharmcodynamic parameters		6 months