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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease; Healthy Subjects

Treatments: Other: placebo; Drug: NSA-789

Study type: Interventional

Funder types: Industry

Identifiers

NCT00795730

3230A1-1002

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Other: placebo

NSA-789

Experimental group

Treatment:

Drug: NSA-789