NCT03649724CompletedPhase 2
The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (actual)
- First submitted
- 22 Aug 2018
- Start date
- 27 Nov 2020
- Primary completion date
- 25 Jul 2026
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Alzheimer disease
- NCT number
- NCT03649724
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 86
- From 27 Nov 2020 to the primary completion date, 25 Jul 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving other investigational drugs within 30 days or 5 half-lives prior to randomization, whichever is longer
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 60 years to 120 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Miller School of Medicine Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Weill Medical College of Cornell University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.