Using Leuprolide to Slow Down Alzheimer's Disease Progression
The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's
This study is testing if the medication leuprolide can help slow down the progression of Alzheimer's disease in women who already have mild cognitive impairment or Alzheimer's while they are taking other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 60 Years to 120 Years |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 3 sites (Boca Raton, Florida and 2 other locations) |
| Trial ID | NCT03649724 on ClinicalTrials.gov |
What this trial studies
The LUCINDA Trial is a phase II, randomized, double-blind, placebo-controlled study evaluating the effects of leuprolide acetate in women with Mild Cognitive Impairment or Alzheimer's Disease who are already on a stable dose of cholinesterase inhibitors. The study aims to assess the efficacy of a 48-week treatment regimen of leuprolide compared to a placebo, focusing on cognitive function, global function, and various biomarkers. This research seeks to confirm previous findings that leuprolide can halt cognitive decline in this patient population and explore its mechanisms of action through neuroimaging and plasma biomarkers.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women diagnosed with probable Alzheimer's Disease or Mild Cognitive Impairment who are stable on cholinesterase inhibitors.
Not a fit: Patients with significant brain diseases other than Alzheimer's, current substance abuse, or severe depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly slow cognitive decline in women with Alzheimer's Disease or Mild Cognitive Impairment.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Boca Raton, Florida and 2 other locations
- University of Miami Miller School of Medicine — Boca Raton, Florida, United States (Recruiting)
- Weill Medical College of Cornell University — New York, New York, United States (Recruiting)
- University of Wisconsin - Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Tracy A Butler, MD — Weill Medical College of Cornell University
- Study coordinator: Sarah Khan
- Email: skh4002@med.cornell.edu
- Phone: 830-582-4632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.