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Slow subject enrollment
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This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-957 | Experimental | ABT-957 administered twice-daily for 7 days |
|
| Placebo | Placebo Comparator | Placebo administered twice-daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-957 | Drug | ABT-957 administered twice-daily for 7 days |
| |
| Placebo for ABT-957 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic evaluation of the two ABT-957 diastereomers | maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), plasma concentration at the end of the dosing interval (Ctrough), the area under the plasma concentration-time curve (AUC) during each dosing interval (AUC0-12 and AUC12-24) | Day 7 |
| Number of subjects with adverse events | Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study | Routinely for the duration of the study, about 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuno Mendonca, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 129545 | Glendale | California | 91206 | United States | ||
| Site Reference ID/Investigator# 129435 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30052328 | Result | Lon HK, Mendonca N, Goss S, Othman AA, Locke C, Jin Z, Rendenbach-Mueller B. Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Alicapistat, a Selective Inhibitor of Human Calpains 1 and 2 for the Treatment of Alzheimer Disease: An Overview of Phase 1 Studies. Clin Pharmacol Drug Dev. 2019 Apr;8(3):290-303. doi: 10.1002/cpdd.598. Epub 2018 Jul 27. |
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| Other |
Placebo for ABT-957 administered twice-daily for 7 days |
|
| Orlando |
| Florida |
| 32806 |
| United States |
| Site Reference ID/Investigator# 129641 | New York | New York | 10019 | United States |
| Site Reference ID/Investigator# 144825 | Salt Lake City | Utah | 84106 | 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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| ID | Term |
|---|---|
| C000707013 | alicapistat |
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