Polaris AD (AR1001) Study - Multiple Locations

The investigational study medication, AR1001. It is designed to help brain cells grow, repair themselves, and communicate. This may slow or reverse early signs of Alzheimer’s disease and mild cognitive impairment progression.

The study drug has been tested in humans and appears to be well tolerated. However, it is not an approved early Alzheimer’s treatment. Therefore, it is considered investigational and can only be used in research.

The study will test a new investigational medication to learn if it can slow or reverse early symptoms of Alzheimer’s disease.

Participation in the POLARIS-AD study lasts for up to 2 years. Study participants can expect the following:

1. Review & Sign the Informed Consent Form
2. Screening Period (up to 6 weeks): Visit the study clinic once or twice to receive assessments to confirm if you qualify. Assessments include cognitive tests, blood and urine tests, and a spinal fluid test, unless you have historical PET scan or spinal fluid test results that meet study criteria. If you qualify, you will be randomly assigned to receive either the oral study drug or a placebo (looks like the study drug but has no active ingredients). You have a 50% chance of receiving the study drug.
3. Study Drug Period (1 year): Take the study drug each morning at home. Visit the study clinic 6 times over 1 year for more assessments like those from Screening. Complete 3 telephone visits to verify safety.
4. Study Extension Period (1 year): Take the study drug each morning at home. All participants will receive study drug during the study extension period. You will not receive placebo during this stage. Visit the study clinic 3 more times for more assessments. Complete 2 telephone visits to verify safety.
5. Follow-up Period (1 month): Visit the study clinic 1-2 more times for safety assessments.

Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.