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The primary objective is to compare mild cognitive impairment in the AL-208 group with the placebo group at 14 + - 3 days after CABG surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-208 | Active Comparator | 1 dose of 300 mg |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-208 | Drug | 1 dose of 300 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study was to compare mild cognitive impairment in the AL-208 group with the placebo group at 14±3 days after coronary artery bypass graft (CABG) surgery. | The primary objective of this study was to compare mild cognitive impairment in the AL-208 group with the placebo group at 14±3 days after coronary artery bypass graft (CABG) surgery. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| The safety profile of AL-208 in subjects undergoing CABG surgery | The safety profile of AL-208 in subjects undergoing CABG surgery | 14 days |
| The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Matthews, MD | Medical Monitor on behalf of Allon Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Clinical Research Corp. | Laguna Hills | California | 92653 | United States | ||
| Sacramento Heart and Vascular Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41173865 | Derived | Gozes I, Blatt J, Guz LS. Systemic davunetide provides sex-specific neuroprotection during Coronary Artery Bypass Grafting (CABG). Transl Psychiatry. 2025 Oct 31;15(1):454. doi: 10.1038/s41398-025-03675-y. |
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| Drug |
1 dose of placebo |
|
The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery
| 14 days |
| Concentration of AL-208 in plasma in subjects undergoing CABG surgery | Concentration of AL-208 in plasma in subjects undergoing CABG surgery | 14 days |
| Sacramento |
| California |
| 95825 |
| United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Piedmont Hospital Research Institute | Atlanta | Georgia | 30309 | United States |
| The Atlanta Heart and Vascular Research Group | Atlanta | Georgia | 30342 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Chicago Heart Institute and Vein Clinic | Elk Grove Village | Illinois | 60007 | United States |
| Illinois Heart and Vascular Foundation | Hindsdale | Illinois | 60521 | United States |
| Indiana/Ohio Heart Cardiothoracic and Vascular Surgeons | Fort Wayne | Indiana | 46804 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Cardiothoracic Associates | Flint | Michigan | 48532 | United States |
| NYU Medical Center | New York | New York | 10016 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Carolina Cardiovascular Surgical Associates, PA | Raleigh | North Carolina | 27610 | United States |
| Memory Assessment and Research Services | Wilmington | North Carolina | 28405 | United States |
| St. Vincent Mary Medical Center | Toledo | Ohio | 43608 | United States |
| Tulsa Clinical Resesarch, LLC | Tulsa | Oklahoma | 74104-5428 | United States |
| Consultants in Cardiovascular Diseases Inc. | Erie | Pennsylvania | 16502 | United States |
| Clinical Research Solutions, PC | Knoxville | Tennessee | 37920 | United States |
| Vanderbilt University | Nashville | Tennessee | 37212 | United States |
| Clinical Cardiovascular Research Center | Dallas | Texas | 75226 | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Cardiac and Thoracic Surgical Associates, Ltd. | Mechanicsville | Virginia | 23116 | United States |
| Multicare Health Systems | Tacoma | Washington | 98415 | United States |
| London health Sciences Centre | London | Ontario | N6A5A5 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G2C4 | Canada |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C425904 | davunetide |
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