The main purpose of the LeUprolide plus Cholinesterase Inhibition to reduce Neurological Decline in Alzheimer's (LUCINDA) study is to determine whether the medication Eligard (leuprolide acetate subcutaneous injection) may slow or prevent decline in thinking abilities and functioning in women with Alzheimer’s Disease (AD) who are also taking the medication donepezil (Aricept). This study is also looking to evaluate whether Leuprolide affects brain structure and/or certain blood tests related to Alzheimer’s Disease.
Leuprolide is approved by the Food and Drug Administration (FDA) for the 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. Use of Leuprolide for Alzheimer’s Disease is experimental, which means that the FDA has not approved Leuprolide for this purpose.
This is a “randomized” study. Randomized means that you are put into a group by chance. It is like flipping a coin. You will be randomly assigned to receive either Leuprolide or placebo injection. You will have an equal chance of being placed in either group. Neither you nor the researchers can choose what group you will be in. Neither you nor the researchers will know what group you are in, but the study doctor can find out if medically necessary.
This study involves approximately eight study visits spread out over one year. Some parts of some visits may be done remotely. This means you could stay at your home and communicate with the study staff member using a phone, computer, or other electronic means.
This study is currently open at Weill Cornell Medicine (New York). Additional sites will be open at the University of Wisconsin- Madison (Wisconsin) and The University of Miami (Florida).