Clinical trial NCT01908010: Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Vital signs
timeFrame: Up to Day 10
measure: ECG (electrocardiogram)
timeFrame: Up to Day 10
measure: Neurological exam
timeFrame: Up to Day 10
measure: Laboratory tests
timeFrame: Up to Day 10
measure: Number of subject with adverse events
timeFrame: Up to Day 10
measure: C-SSRS (Columbia-Suicide Severity Rating Scale)
timeFrame: Up to Day 10
Secondary outcomes:
measure: Pharmacokinetic parameters
timeFrame: Up to Day 10
Other outcomes:
Locations:
city: Miami
country: United States
facility: Site Reference ID/Investigator# 106999
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 106998
state: Florida
city: Overland Park
country: United States
facility: Site Reference ID/Investigator# 107000
state: Kansas
Study officials:
affiliation: AbbVie
name: Gerard Marek, MD
role: STUDY_DIRECTOR
References: