Summary:
This is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of GC021109 in subjects with mild to moderate Alzheimer's Disease. The Investigator, study site staff, (with exception of a designated pharmacist/pharmacy technician) and all study subjects will be blinded to randomized study medication assignment until database lock. Treatment assignments may be unblinded for select pre-authorized individuals involved in the safety and PK data reviews in order to accurately determine how to proceed with dose escalation.
Ages Eligible for Study: 55 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
- Male or female subjects aged 55-85 years, inclusive, at the time of informed consent.
- Subjects diagnosed with mild to moderate AD as determined by the following:
- Diagnosis of probable AD according to the 2011 NIA-AA criteria
- MMSE (using serial 7's) score of 12-26 at screening (Mild defined as 20-26 and Moderate defined as 12-19)
- Documentation in the clinic notes of mild/moderate AD
- If on AD therapy, stable dose for at least 3 months prior to screening.
Qualified Participants May Receive:
Study-related medical care and study medication at no cost and may be compensated for time and travel.