Mild Cognitive Impairment
Conditions
Keywords
MCI following CABG surgery
Brief summary
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
Interventions
DRUGAL-208
1 dose of 300 mg
DRUGPlacebo
1 dose of placebo
Sponsors
Allon Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females (of non-childbearing potential), 50 to 79 years of age. 2. Undergoing CABG surgery with the use of extracorporeal circulation. 3. Willing and able to complete cognitive testing. 4. Score \< 16 on the Center for Epidemiological Studies in Depression scale (CES-D). 5. Score \> or = 28 on the Mini-Mental State Examination (MMSE). 6. Willing and able to provide informed consent to participate in this study 7. Fluency in written and spoken English.
Exclusion criteria
1. Presence of any severe mental illness that could affect interpretation of efficacy data, such as schizophrenia or bipolar affective disorder; any untreated or unstable psychiatric condition including depressive disorder or anxiety disorder. 2. History of stroke or other significant neurological disorder 3. Transient ischemic attack (TIA) with ongoing cognitive sequelae 4. Chronic atrial fibrillation or uncontrolled atrial fibrillation prior to surgery 5. Myocardial infarction (MI) within the last 8 weeks and/or previous history of more than 3 MIs 6. History of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes \> 2.5 x upper limit or normal (ULN) at screening). 7. History of renal dysfunction with ongoing sequelae (including but not limited to creatinine value \> 2.5 mg/dL at screening). 8. Known active alcohol or drug abuse. 9. Concurrent use of prescription medications known to enhance memory 10. General anesthesia (defined as anesthesia requiring intubation or ventilatory support) within 3 months prior to randomization. 11. Cardiopulmonary bypass or thoracotomy within 2 years prior to randomization. 12. Undergoing valvular repair or replacement during scheduled CABG surgery. 13. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy. 14. Decompensating congestive heart disease 15. Subjects on immunosuppressive drugs, such as azathioprine, chemotherapeutic agents, mycophenolate, monoclonal antibodies, or more than 20 mg/day prednisone, within the previous 3 months 16. Receipt of any investigational agent or device within 30 days of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety profile of AL-208 in subjects undergoing CABG surgery | 14 days | The safety profile of AL-208 in subjects undergoing CABG surgery |
| The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery | 14 days | The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery |
| Concentration of AL-208 in plasma in subjects undergoing CABG surgery | 14 days | Concentration of AL-208 in plasma in subjects undergoing CABG surgery |
Countries
Canada, United States
Outcome results
None listed