What are Phases of Clinical Trials?
The development of new treatments usually progresses through levels of research, called phases, in the process of testing new drugs and procedures before they can be approved and released for general use.
Who Conducts the Clinical Trial?
Every clinical trial is led by a “principal investigator,” often a medical doctor or other medical professional. The principal investigator leads the research team that might include doctors, nurses and other health care professionals. The principal investigator is responsible for making sure the study is carried out properly and safely.
How Are Clinical Trial Participants Protected?
Before joining a study, participants undergo a process of Informed Consent, which includes discussion of the risks and potential benefits of participating in a study.
The institution conducting the research must utilize an Institutional Review Board (IRB). The IRB is made up of physicians, researchers, and community members. The board reviews every study before deciding if the study can move forward. The main focus of the IRB is to protect the rights and welfare of study participants. The IRB monitors each study, at least annually, throughout the life of the study.
The Food and Drug Administration (FDA) has strict regulations for the conduct of clinical trials to ensure the protection of study participants.
For additional inquires, contact JCTOSRC@med.cornell.edu
Who Can Participate in a Clinical Trial?
Many studies are designed for people with specific diseases or conditions. Others are looking for healthy volunteers, and some studies enroll both individuals with diseases/conditions, as well as, healthy volunteers for comparison. Every clinical trial has detailed criteria that determine whether an individual is eligible to participate.
What is Leuprolide normally used for?
Leuprolide is approved by the FDA for treatment of prostate cancer in men, endometriosis in women and early puberty in children. It is also commonly used in women preparing for in vitro fertilization. LUCINDA aims to repurpose Leuprolide for Alzheimer's Disease.
Who can join this study?
This study is open to women over age 65 diagnosed with Mild Cognitive Impairment or Alzheimer’s Disease who are taking a stable dose of the medication donepezil (Aricept) Participants must have a study partner (friend, family member or caregiver) who spends at least ten hours per week with them and can accompany them to all study visits.
What does the study involve?
If you are interested, a research coordinator will give you detailed information about the study. You will be asked to sign an informed consent form. There will be approximately 8 study visits spread out over 1 year. Study procedures include tests of thinking abilities, blood tests, two MRI scans and one PET scan to measure amyloid in the brain. There will be injection of study drug (Leuprolide or placebo) 4 times over 1 year.
Why would Leuprolide help with Alzheimer’s Disease?
Prior research in animals and humans suggests that Leuprolide helps with Alzheimer’s Disease via several mechanisms including regulation of brain cell replication and reduction of inflammation.
Are there risks or side effects?
Yes. Potential risks and side effects will be discussed with you in detail before you decide to join the study.
Will it cost me anything to be in this study?
No. You will be compensated for your time and effort.