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

Description

The LUCINDA Trial is a three-site, phase II, randomized, double-blind, placebo-controlled study of leuprolide acetate (Eligard) in women with Mild Cognitive Impairment or Alzheimer's Disease taking a stable dose of a cholinesterase inhibitor medication like donepezil. Its objective is to assess the efficacy of a 48-week regimen of leuprolide (22.5 mg per 12 weeks) compared to placebo on cognitive function, global function and plasma and neuroimaging biomarkers.

Conditions

Alzheimer Disease, Mild Cognitive Impairment

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Study Overview

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Study Details

Study overview

The LUCINDA Trial is a three-site, phase II, randomized, double-blind, placebo-controlled study of leuprolide acetate (Eligard) in women with Mild Cognitive Impairment or Alzheimer's Disease taking a stable dose of a cholinesterase inhibitor medication like donepezil. Its objective is to assess the efficacy of a 48-week regimen of leuprolide (22.5 mg per 12 weeks) compared to placebo on cognitive function, global function and plasma and neuroimaging biomarkers.

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

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

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Boca Raton

University of Miami Miller School of Medicine, Boca Raton, Florida, United States, 33433

New York

Weill Medical College of Cornell University, New York, New York, United States, 10021

Madison

University of Wisconsin - Madison, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female, post-menopausal
  • * Probable AD or MCI due to AD according to NIA-AA criteria
  • * Taking a stable dose of a cholinesterase inhibitor such as donepezil/Aricept and dosage likely to remain stable throughout the trial
  • * MOCA \> 11 or blind MOCA \> 8 (inclusive) at screening visit
  • * Hachinski score \<5 supporting clinical judgment that dementia is not of vascular origin
  • * Fluent in English
  • * has a study partner / caregiver who interacts with the subject for at least 5 hours per week on average and can participate in evaluations
  • * Presence based on exam, history or MRI of significant brain disease other than AD such as schizophrenia, epilepsy, Parkinson's disease or large territory stroke
  • * Current substance abuse in accord with DSM V criteria
  • * Significantly depressed (Geriatric Depression Scale \> 10)
  • * Physical or psychological MRI contraindications, or likely unable to tolerate neuroimaging
  • * Taking other medications known to affect serum sex hormone or gonadotropin concentrations such as estrogen and/or progesterone for hormone replacement therapy, goserelin or danazol
  • * Presence of significant systemic illness likely to interfere with participation in or completion of the study or to affect study results such as cancer within 5 years (other than non-melanoma 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

Ages Eligible for Study

60 Years to 120 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

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

Study Record Dates

2026-02