- ICH GCP
- US Clinical Trials Registry
- 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
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33169
- Site Reference ID/Investigator# 106999
-
Orlando, Florida, United States, 32806
- Site Reference ID/Investigator# 106998
-
-
Kansas
-
Overland Park, Kansas, United States, 66212
- Site Reference ID/Investigator# 107000
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1, low dose
ABT-354
|
Placebo
ABT-354 Low Dose
ABT-354 High Dose
|
EXPERIMENTAL: Group 2, high dose
ABT-354
|
Placebo
ABT-354 Low Dose
ABT-354 High Dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vital signs
Time Frame: Up to Day 10
|
Up to Day 10
|
|
ECG (electrocardiogram)
Time Frame: Up to Day 10
|
Up to Day 10
|
|
Neurological exam
Time Frame: Up to Day 10
|
Up to Day 10
|
|
Laboratory tests
Time Frame: Up to Day 10
|
Hematology, Chemistry, Urinalysis
|
Up to Day 10
|
Number of subject with adverse events
Time Frame: Up to Day 10
|
Up to Day 10
|
|
C-SSRS (Columbia-Suicide Severity Rating Scale)
Time Frame: Up to Day 10
|
Up to Day 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameters
Time Frame: Up to Day 10
|
Cmax, Cmin, Tmax, AUC, t-1/2, CL/F
|
Up to Day 10
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M13-080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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