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

What Is This Study About?

This phase 2 trial will assess the effects of an existing drug, leuprolide acetate (Eligard), in women with Mild Cognitive Impairment or Alzheimer's disease who take a stable dose of donepezil (Aricept). 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 measure cognitive function and overall function, as well as plasma and neuroimaging biomarkers of Alzheimer's by MRI.

Do I Qualify To Participate in This Study?

Must have:

• Female
• Postmenopausal
• Probable Alzheimer's disease, or Mild Cognitive Impairment due to Alzheimer's disease, at screening visit
• MoCA score of more than 11 or a blind MoCA score greater than 8
• 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

Must NOT have:

• 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

Florida
University of Miami Miller School of Medicine Boca Raton, FL 33433 Recruiting Adolfo M Henriquez, MA 561-869-6820 amh122@miami.edu
New York
Weill Medical College of Cornell University New York, NY 10021 Recruiting Sarah Khan 830-582-4632 skh4002@med.cornell.edu
Wisconsin
University of Wisconsin - Madison Madison, WI 53792 Recruiting Maggie Chilsen 608-263-2704 mchilsen@clinicaltrials.wisc.edu

Who Sponsors This Study?

Lead: Weill Medical College of Cornell University

Collaborator Sponsor

• National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT03649724