A Phase III Safety and Efficacy Study of ALTZ2OP1 in Subjects with Evidence of Early Alzheimer's Disease
February 10, 2017
Steven Potkin, MD
UC Irvine Medical Center in Orange, CA
The purpose of this study is to test the effects of two drugs on Alzheimer's disease (AD) — cromolyn sodium and ibuprofen. These two drugs have been approved for use in humans since the 1970s for the treatment of other illnesses. These two drugs have never been tested as a combination treatment for AD, and the use of these drugs, either alone or in combination, is investigational and not approved by the FDA for the treatment of AD.
This research will investigate whether one drug or the combination of the two has any effect on dementia. It will also examine any side effects that subjects might experience.
You are eligible to participate in this study if you are between 55-79 years of age and:
- Have probable early Alzheimer's disease
- Have a qualified study partner to participate in this study. A qualified study partner is a person (spouse, adult child, or other) who has an average of 10 hours per week of contact with you and who can accompany you to all clinic visits for the duration of this study.
- Are willing to undergo all study procedures at the study center over the study period
There are 7 scheduled visits (including a screening visit to determine ability to be in the study) over a 76-week period. Each visit is expected to last approximately 2 to 3 hours.
Symptoms associated with Alzheimer's disease may improve while subjects are participating in this study, but this cannot be guaranteed.
Total compensation for completing the study as a subject is up to $1,200 over the study period.
Ioana Popica, Clinical Research Coordinator