ACTIVE_NOT_RECRUITING

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

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Conditions

Alzheimer DiseaseMild Cognitive Impairment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-11-27
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03649724

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.

Ages Eligible for Study:60 Years to 120 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female, post-menopausal
  2. * Probable AD or MCI due to AD according to NIA-AA criteria
  3. * Taking a stable dose of a cholinesterase inhibitor such as donepezil/Aricept and dosage likely to remain stable throughout the trial
  4. * MOCA \> 11 or blind MOCA \> 8 (inclusive) at screening visit
  5. * Hachinski score \<5 supporting clinical judgment that dementia is not of vascular origin
  6. * Fluent in English
  7. * has a study partner / caregiver who interacts with the subject for at least 5 hours per week on average and can participate in evaluations
  1. * 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
  2. * Current substance abuse in accord with DSM V criteria
  3. * Significantly depressed (Geriatric Depression Scale \> 10)
  4. * Physical or psychological MRI contraindications, or likely unable to tolerate neuroimaging
  5. * 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
  6. * 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
  7. * Receiving other investigational drugs within 30 days or 5 half-lives prior to randomization, whichever is longer

Contacts and Locations

Principal Investigator

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 Locations (Sites)

University of Miami Miller School of Medicine
Boca Raton, Florida, 33433
United States
Weill Medical College of Cornell University
New York, New York, 10021
United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-27
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2020-11-27
Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Alzheimer Disease
  • Mild Cognitive Impairment