Ongoing Clinical Trials in Neurodegenerative Diseases:
We are currently conducting clinical studies of our lead candidate, CT1812, in several indications described below. CT1812 is an experimental candidate and has not been approved by the U.S. FDA or other regulatory agency. If you have questions about any of the studies you see listed, please consult with your physician.
The Phase 2 SHIMMER study is currently recruiting individuals (50 to 85 years of age) who have mild-to-moderate dementia with Lewy bodies. SHIMMER will enroll up to 120 participants in the United States who will be randomized to receive either a standard-of-care treatment or the experimental candidate, CT1812 for six months. More information may be found at shimmerDLBstudy.com or on clinicaltrials.gov under trial identifier NCT05225415.
Additional Resource for Patients and their Families
Clinical Trial Terminology
Before a novel product candidate can be approved, it must complete a rigorous clinical development process, which typically includes three distinct types of trials. Phase 1 clinical trials test experimental treatments at a variety of doses in healthy volunteers to understand how the candidate works in the human body and identify safety issues that may not have been apparent in preclinical research.
Following successful completion of Phase 1 trials, experimental therapies often advance into one or more Phase 2 trials to evaluate the efficacy and safety of a candidate in the target patient population. Goals for Phase 2 trials may include selecting an optimal dose or dosing regimen, identifying specific patient group who may respond to medication more or less favorably, and assessing the safety and tolerability profile. Meetings with the U.S. Food and Drug Administration and other countries’ regulatory authorities are held following the conclusion of Phase 2 clinical trials to review data before proceeding into the next phase of development.
Phase 3 trials are the final step in a product’s clinical develop and are designed to test the optimal dose or dosing regimen in a large number of people with a specific disease or condition. They aim to enroll people with diversity in race, gender, geography, and socioeconomic status to mirror the conditions in which a candidate might be used in the future when it’s broadly available.
Because these studies involve experimental treatments, all clinical trials are closely monitored by regulatory authorities as well as independent ethics committees (IECs) or institutional review boards (IRBs) to ensure that any safety issues that arise are carefully documented.
Expanded Access Policy
We are a clinical stage biopharmaceutical company engaged in the development of small-molecule therapeutics targeting age-related degenerative diseases. We currently have several clinical studies planned or underway that are designed to measure safety and efficacy outcomes of our experimental medications for patients with Alzheimer’s disease, GA secondary to dry age-related macular degeneration and dementia with Lewy bodies.
At this time, we do not offer expanded access to any of our therapies in development. Rather, before our drug candidates complete their clinical development and are reviewed and approved by regulatory authorities, they can only be accessed through participation in our clinical trials.