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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1, low dose | Experimental | ABT-354 |
|
| Group 2, high dose | Experimental | ABT-354 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-354 | Drug | ABT-354 Low Dose |
| |
| ABT-354 |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs | Up to Day 10 | |
| ECG (electrocardiogram) | Up to Day 10 | |
| Neurological exam | Up to Day 10 | |
| Laboratory tests | Hematology, Chemistry, Urinalysis | Up to Day 10 |
| Number of subject with adverse events | Up to Day 10 | |
| C-SSRS (Columbia-Suicide Severity Rating Scale) | Up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | Cmax, Cmin, Tmax, AUC, t-1/2, CL/F | Up to Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Marek, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 106999 | Miami | Florida | 33169 | United States | ||
| Site Reference ID/Investigator# 106998 |
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| Drug |
ABT-354 High Dose |
|
| Placebo | Drug | Placebo |
|
| Orlando |
| Florida |
| 32806 |
| United States |
| Site Reference ID/Investigator# 107000 | Overland Park | Kansas | 66212 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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