Skip to main content

Leuprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (LUCINDA)

Recruiting

The LUCINDA Trial will test an existing drug, leuprolide acetate (Eligard), in women with Alzheimer's disease who take a stable dose of donepezil (Aricept) and assess its effects on cognitive function, overall function, and plasma and neuroimaging biomarkers.

Minimum Age Maximum Age Gender Healthy Volunteers
65 Years 90 Years Female No
February 2020
February 2026
180

  • Female
  • Postmenopausal
  • Probable Alzheimer's disease; MMSE score of 16-26 (inclusive) at screening visit
  • Hachinski score <5 supporting clinical judgment that dementia is not of vascular origin
  • Taking a stable dose of donepezil (Aricept) for at least 90 days, and dosage likely to remain stable throughout the trial
  • Fluent in English
  • Living at home or in a facility other than a nursing home with a caregiver who sees the patient at least three times a week for a total of at least 10 hours and can sign the consent form, accompany the patient on clinic visits, and participate in evaluations

  • Significant brain disease other than Alzheimer's, such as schizophrenia, epilepsy, Parkinson's disease, or stroke
  • Current substance abuse
  • Significant depression
  • Physical or psychological magnetic resonance imaging (MRI) contraindications or likely unable to tolerate neuroimaging
  • Prohibited medications: memantine (Namenda); other medications known to affect serum sex hormone or gonadotropin concentrations, such as estrogen and/or progesterone for hormone replacement therapy, goserelin, or danazol
  • Significant systemic illness likely to interfere with participation or completion of study or to affect study results, such as cancer within past 5 years (other than nonmelanoma skin cancer), autoimmune disease, recent myocardial infarction, signs/symptoms of organ failure based on history, ECG, screening laboratory and/or physical exams
  • Receiving other investigational drugs within 30 days or 5 half-lives prior to randomization, whichever is longer
  • Ever treated with active or passive immunization as part of a different clinical trial for Alzheimer's

Participants will be randomly assigned to take either the study drug or a placebo as an injection given once every 12 weeks for 48 weeks (total of four injections). Researchers will determine whether the drug affects cognition, as well as neuroimaging and plasma biomarkers of Alzheimer's, measured by MRI. 

Leurprolide is a gonadotropin-releasing hormone (GnRH) analogue approved to treat prostate cancer, endometriosis, and uterine fibroids, and in preparation for in-vitro fertilization. Possible mechanisms of action in Alzheimer's include decreasing levels of luteinizing hormone, which may preserve cognition, decreasing amyloid deposition and tau phosphorylation, and reducing inflammation in the brain.

Name City State Zip Status Primary Contact
University of Miami Miller School of Medicine
Palm Beach Gardens Florida 33410 Not yet recruiting Olena Mahneva, PhD

Weill Medical College of Cornell University
New York New York 10021 Recruiting Patrick Harvey, MA
646-962-8508
pah2018@med.cornell.edu
University of Wisconsin - Madison
Madison Wisconsin 53792 Not yet recruiting Rebecca Kintner
608-262-3456
rkintner@clinicaltrials.wisc.edu

Weill Medical College of Cornell University

  • National Institute on Aging (NIA)

Name Role Affiliation
Tracy A Butler, MD Principal Investigator Weill Medical College of Cornell University
James E Galvin, MD Principal Investigator University of Miami
Craig S Atwood, PhD Principal Investigator University of Wisconsin, Madison

Name Phone Email
Patrick Harvey, MA (646) 962-8508 pah2018@med.cornell.edu
Tom Maloney, PhD 646-962-8502 trm4001@med.cornell.edu

NCT03649724

The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's