Clinical Trial 45351


Summary:

This study is designed to evaluate treatment effects of ATH-1017 in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks. This study is designed to assess the correlation of the functional translational biomarker P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized, double-blind treatment.


Qualified Participants Must:

• Be between the ages 55 to 85 years
• Have mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at the Screening visit
• Have a clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
• Must have a reliable and capable support person/caregiver
• Must be treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as: Treatment-naive, OR Subjects who received continuous dosing for at least 6 months, and are on a stable, approved dose of an AChEI for at least 3 months before Screening OR Subjects who received an AChEI in the past and discontinued, e.g., due to tolerability issues, OR For subjects who received high dose donepezil at 23 mg PO, or galantamine at 24 mg PO or patch, a 3-month drug-free period is required between the last dose received and Screening.


Qualified Participants May Receive:

The study drug free who are enrolled in the study; May also receive a stipend to compensate for time and effort for study participation including meals, travel, etc.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.