Cognition Therapeutics is currently not providing our investigational medicine, Elayta™, outside of our ongoing clinical trial program. If you or a loved one are interested in participating in a clinical trial for Elayta, please visit www.clinicaltrials.gov, where we will list enrolling and planned clinical trials along with their eligibility criteria and participating clinical center locations. Talk with your doctor about these and other clinical trials listed in the database to see if they are options for you.
Developing new medicines is our life’s work, and all of us at Cognition understand that patients with Alzheimer’s disease and their families are in dire need of effective treatment options. Our goal is to develop a safe and effective medicine for treating Alzheimer’s disease through a systematic and thorough research program that strives to balance scientific rigor with speed.
Cognition Therapeutics believes that clinical trials offer patients the best means to access medicines prior to approval by regulators like the US Food and Drug Administration (FDA) and the Therapeutic Goods Administration in Australia. Providing our investigational drug only in clinical trials safeguards patients by ensuring that our experimental medicine is used in appropriate settings where safety can be closely monitored. Further, by concentrating our resources on the execution of our clinical program, we will reach regulatory review of Elayta in as rapid a timeframe as possible. By conducting our clinical trials properly, regulators will be more likely to approve the drug, having found it to be safe and effective. After approval, the drug will be broadly available to all who need it. Thus, we feel convinced that concentrating our efforts on rigorous, properly controlled clinical trials will, in the long run, help the largest number of patients.
In our initial clinical testing of Elayta, this experimental medicine was shown to be well tolerated in healthy people. Elayta’s long-term safety profile and potential efficacy in Alzheimer’s disease patients has yet to be determined. It is important to recognize that an experimental medicine’s safety profile can only be established as the medicine is tested in larger, sicker, and more diverse patient populations. A drug that is safe in healthy people may not be safe in people with Alzheimer’s disease or other conditions, in the elderly, or in people with a particular genetic profile. Thus, while our experimental medicine may be safe in healthy people, we cannot know how different populations will react to it until we have thoroughly tested it.
Cognition Therapeutics will periodically reevaluate our Pre-Approval Access policy and will provide updated information on its website. We also will maintain an email address, email@example.com, for further inquiries. We will endeavor to respond to any questions with one week.
If you wish to learn more about the ethical issues surrounding access to experimental medicines before they have received regulatory approval, please visit the website of the NYU Working Group on Compassionate Use and Pre-Approval Access by clicking here or the website of the Biotechnology Innovation Organization by clicking here. If you wish to learn more about options available to patients with Alzheimer’s disease, please consider the following resources:
- National Institute on Aging: www.nia.nih.gov/alzheimers
- Alzheimer’s Association: www.alz.org/research
- Alzheimer’s Prevention Registry: www.endalznow.org
- Alzheimer’s Foundation of America: www.alzfdn.org
One behalf of everyone associated with Cognition Therapeutics, we thank you for your interest in our company and in Elayta.