Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate safety, tolerability and pharmacokinetics of ABT-354 in up to 20 male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Cholinesterase Inhibitors

Criteria

Inclusion Criteria:

• Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's Disease

• Has a Mini-Mental State Examination total score of 16 to 26, inclusive, at Screening

• Has a Modified Hachinski Ischemia Scale score of ≤ 4 at Screening

• On a stable dose of - donepezil, galantamine or rivastigmine for at least 30 days prior to study drug administration

• Has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization

Exclusion Criteria:

• Receipt of any depot drug by injection within 30 days prior to study drug administration

• Receipt of an investigational product within a time period equal to 10 half-lives, if known, or within 6 weeks prior to study drug administration

• History of any significant neurological disease other than Alzheimer's Disease

• History of significant sensitivity or allergy to multiple drugs based on medical records and/or the opinion of the investigator

• Significant current - suicidal ideation within 1 month prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale completed at Screening or any history of suicide attempts