A Phase 2 Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of BHV-4157 in Patients with Mild to Moderate Alzheimer's Disease (BHV4157-203)

Grants and Contracts Details


HUMAN CLINICAL TRIAL - 1. Ensure proper informed consent is obtained prior to any study-­?related procedures being performed. 2. Full compliance with specified inclusion/exclusion criteria cited in the protocol. 3. Full compliance with all procedures specified in the protocol, in the procedures manual and imaging technical manuals. 4. Carry out all evaluations within time limits specified in the procedures manual for the protocol. 5. Proper collection and submission of all required online data entry forms within the time limits specified in the procedures/technical manual(s) for the protocol. 6. Proper collection, storage and shipment of laboratory specimens for safety monitoring, laboratory surveillance, compliance monitoring, biomarker research and storage for future research studies. 7. Proper reporting of all adverse events (AE), with serious adverse events (SAE) within 24 hrs of site notification, as well as following participants with AEs until the events have subsided, the conditions are considered medically stable, or the participants are no longer available for follow up. 8. Prompt response to requests (administrative or data-­?related) from the Coordinating Center by email, phone, or through data query tool. 9. This study will use the ADCS EDC for electronic data capture (eCRF entry). Sites must have the capability to access and use the ADCS EDC throughout the trial. Data from the screening visit must be entered within 3 days of being generated by site. Data from all subsequent visits within 5 days. 10. MRI Data must be uploaded on the same day as the scan and data entered into the eCRF within 24 hours. 11. Ensure scanner compliance by following specified imaging protocols as specified in the Technical Manuals for MRI by reporting any modifications to scanners to the Coordinating Center and the MRI core (respectively) in case re-­?certification is required. 12. Ability to procure any study materials and supplies not provided by the Coordinating Center in order to conduct research-­?appropriate storage and accounting. 13. Clinical Conductor by Bio-optronics will be used as the Clinical Trials Management System (CTMS) in this study. Sites must have the capability to access and use Clinical Conductor throughout the trial.
Effective start/end date8/14/184/5/22


  • University of California San Diego Health: $497,427.00


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