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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908010
• Other study ID #: M13-080
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2013
• Last updated: December 9, 2013
• Start date: July 2013
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This is a double-blind, placebo-controlled, randomized, multiple-dose, multicenter study. Up to 20 male and female subjects with mild to moderate Alzheimer's disease (AD) who are taking stable doses of acetylcholinesterase inhibitors will be enrolled in this study. Within 28 days prior to study drug administration, subjects will be screened based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD, Mini-Mental State Examination (MMSE) and Modified Hachinski Ischemic Scale (MHIS) scores, medical history, physical examination, neurological examination, vital signs, ECG, laboratory tests and response to Columbia-Suicide Severity Rating Scale (C-SSRS).

The study will be performed in two groups of 10 subjects each. In each group of 10 subjects, 7 subjects will be randomly assigned to receive ABT-354 and 3 subjects to receive matching placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ABT-354
ABT-354 Low Dose
• ABT-354
ABT-354 High Dose
• Placebo
Placebo

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs		Up to Day 10	Yes
Primary	ECG (electrocardiogram)		Up to Day 10	Yes
Primary	Neurological exam		Up to Day 10	Yes
Primary	Laboratory tests	Hematology, Chemistry, Urinalysis	Up to Day 10	Yes
Primary	Number of subject with adverse events		Up to Day 10	Yes
Primary	C-SSRS (Columbia-Suicide Severity Rating Scale)		Up to Day 10	Yes
Secondary	Pharmacokinetic parameters	Cmax, Cmin, Tmax, AUC, t-1/2, CL/F	Up to Day 10	No