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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01908010

Run by

AbbVie

People needed

20

Starts

2013-07-01

Expected to finish

2013-11-01

Last updated by the study team

2013-12-11

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site Reference ID/Investigator# 106999 — Miami, Florida, United States
• Site Reference ID/Investigator# 106998 — Orlando, Florida, United States
• Site Reference ID/Investigator# 107000 — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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