This is a multi-center, open label, expanded access program (EAP) that will provide 100 mg CT1812 for up to one year to participants with mild-to-moderate DLB.
Participants will be screened for eligibility by physical, laboratory, and select psychometric and neurologic assessments. Participants, after having met all inclusion criteria, and none of the exclusion criteria, will be enrolled. The first dose will be taken in the clinic. Participants and their caregivers/study partner will have a study visit clinic for repeat psychometric/neurologic testing, safety procedures and lab sample collection. Each participant and caregiver/study partner will participate in a screening period of up to 7 days, followed by an open label treatment period of 720 (± 4 days) days and a follow up phone call at day 750 (± 4 days) for a maximum of 757 days of study participation including screening.
Study Type
EXPANDED_ACCESS
Zervimesine (CT1812) was shown to be safe and well tolerated in a study of healthy volunteers and in Phases 1 and 2 studies of participants with mild to moderate AD and DLB. This is an open label expanded access program designed to provide access to CT1812 and to evaluate the long-term safety of CT1812 administered once daily in adults aged 50 to 86 who have been diagnosed with mild to moderate DLB (the targeted clinical indication for CT1812). Participants will receive 100 mg of CT1812 once daily for the entire study.
Banner Sun Health Research Institute
Sun City, Arizona, United States
Stanford Neuroscience Heath Center
Palo Alto, California, United States
University of Colorado Denver - Anschutz Medical Campus
Aurora, Colorado, United States
University of Miami - Department of Neurology
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Boca Raton, Florida, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio, United States
Summit Headlands LLC
Portland, Oregon, United States