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The LUCINDA Trial

Clinical Trial Details

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.

Key Eligibility: 
  • Women over age 65
  • Diagnosed with Alzheimer's Disease
  • Taking the medication donepezil (Aricept)
  • Participants must have a study partner (friend or family member) who can participate in all study visits.
  • Detailed eligibility will be reviewed with the study team.

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).

Study contact by location

Upper East Side - Manhattan

Contact(s)

Sarah Khan
1-830-LUCINDA
skh4002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1905020209

ClinicalTrials.gov:

NCT03649724

Status

Open to Enrollment

Age Group

Adult

Sponsor