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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00795730
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 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
• Actual Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

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

Outcome Measures

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 [6 months]

Secondary Outcome Measures

1. Pharmacokinetic and pharmcodynamic parameters [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
• ClinicalTrials.gov Identifier: NCT00795730
• Other Study ID Numbers: 3230A1-1002
• First Posted: Nov 21, 2008
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer: Alzheimer's Disease; schizophrenia
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Aug 20, 2021