CY6463 acts on the nitric oxide signaling pathway in the brain. This pathway is important for many aspects of brain health, including control of blood flow in the brain, how brain cells use energy, and how those cells communicate with one another. Impairment of this pathway is a critical part of the origin of many neurological diseases that can cause a loss of brain function, including memory and decision-making abilities.
CY6463 may help people with AD and cardiovascular disease maintain or recover some of their original cognitive function due to CY6463’s expected impact on neurons and blood vessels in the brain.
In addition to evaluating the safety of CY6463, this study will explore whether CY6463 improves blood flow in the brain, diminishes signs of brain degeneration and inflammation, and improves brain function. Cognitive tests will also be conducted to evaluate whether CY6463 improves memory and attention.
Travel assistance may be available, including transportation to and from the study visits for you and a care partner.
To learn more, please speak with a member of the study staff.
Participants will take study drug tablets by mouth each day for about 87 days (~3 months). About half of the participants will be randomized to take CY6463 and the other half will be randomized to take placebo (a pill with no active drug in it). Neither the participants nor the study doctors will know which type of pill each participant is taking.
Participants will complete 7 scheduled visits over about 5 months, from Screening (up to 60 days) through Follow-up (about 14 days after the last dose), with each visit lasting most of the day. The schedule allows the activities for a given visit to be split across multiple days, if needed.
Study Activities May Include:
Participants will visit their study doctors who will assess their health and disease status and perform tests of brain activity. The brain tests are not invasive, which means they take measurements from outside of the body, and include electroencephalography (or “EEG”), which measures electrical activity of the brain, and magnetic resonance imaging (or “MRI”), which takes pictures of the brain.
Participants will take study drug tablets by mouth once each day during the treatment period and will be asked to complete a daily diary.
During each study visit, blood will be collected, vital signs will be measured, and the heart will be checked using an electrocardiogram (or “ECG”). Several questionnaires will also be administered, including a few that assess cognitive function.
Two samples of cerebral spinal fluid (the clear fluid that surrounds the brain and spinal cord), will be collected: one at the beginning of the study before the first dose of study drug, and the other at the end of the study, after the last dose of study drug.