NCT03649724 · Phase 2 · ACTIVE NOT RECRUITING
The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's
The LUCINDA Trial is testing whether leuprolide acetate, a hormone-suppressing drug already used for other conditions, can slow cognitive decline when added to a cholinesterase inhibitor like donepezil. It enrolls post-menopausal women with MCI or early Alzheimer's and runs for 48 weeks. This is a Phase 2 trial, meaning researchers are testing whether it works and is safe — it is not proven or approved for this use.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-16