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Insufficient target engagement of ABT-957 (preclinical data)
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This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) due to AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-957 | Experimental | ABT-957 given twice a day for 84 days |
|
| Placebo | Placebo Comparator | Placebo given twice a day for 84 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-957 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting treatment-emergent adverse events | For approximately 84 days | |
| Level of spectrin breakdown product-145 (SBDP-145) | 84 days |
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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# 143180 | Cypress | California | 90630 | United States | ||
| Site Reference ID/Investigator# 143178 |
| 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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|
| Orlando |
| Florida |
| 32806 |
| United States |
| Site Reference ID/Investigator# 149484 | The Villages | Florida | 32162 | United States |
| Site Reference ID/Investigator# 143181 | Marlton | New Jersey | 08053 | United States |
| Site Reference ID/Investigator# 143182 | Cincinnati | Ohio | 45255 | United States |
| Site Reference ID/Investigator# 149481 | Dallas | Texas | 75231 | United States |
| Site Reference ID/Investigator# 143254 | Orem | Utah | 84058 | United States |
| Site Reference ID/Investigator# 143179 | Salt Lake City | Utah | 84107 | United States |
| Site Reference ID/Investigator# 143177 | Spokane | Washington | 99202 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| 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 |
| D003072 | Cognition Disorders |
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| ID | Term |
|---|---|
| C000707013 | alicapistat |
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