Cortexyme Announces Gain Trial in Alzheimer’s Disease Has Reached Enrollment Milestone of 300 Patients
- Sub-study shows greater than 90% of enrolled patients have moderate to severe periodontal disease, indicating relevance to mechanism of action against P. gingivalis
- Interim analysis of the Phase 2/3 GAIN Trial expected to occur before year-end 2020
The target of COR388, gingipains produced by P. gingivalis, have been discovered in the brain of Alzheimer’s patients and shown to produce Alzheimer’s pathology in infected animals. P. gingivalis is best known as a keystone bacterium in the development of periodontal disease. The GAIN Trial includes a periodontal sub-study, in which approximately 40% of GAIN Trial participants are also assessed for endpoints of efficacy in periodontal disease. The GAIN Trial and the sub-study did not specify inclusion criteria related to periodontal status, and yet greater than 90% of patients enrolled had moderate to severe periodontal disease at baseline.
“We are pleased with the high level of engagement of our clinical sites and study participants, as well as with the operational execution of our team,” said
For more information about the GAIN Trial, visit www.GAINtrial.com.
About the GAIN Trial
The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer’s Disease) Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating the efficacy, safety, and tolerability of COR388, Cortexyme’s investigational gingipain inhibitor, in patients with mild to moderate Alzheimer’s disease. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease including gingival pocket depth. The GAIN Trial has been enrolling since the second quarter of 2019, with top-line results from the study’s final analysis expected in the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.
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