Active — Not RecruitingPhase 2

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

United States180 participantsStarted 2020-11-27

Plain-language summary

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.

Who can participate

Age range

60 Years – 120 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Receivi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines leuprolide, a hormone-suppressing drug, with a cholinesterase inhibitor — do you think that combination makes sense for my specific situation, and am I already on a cholinesterase inhibitor that could affect whether I'd be eligible or how I'd respond?
2Since LUCINDA is a Phase 2 trial, the main goal is still to test whether this approach is safe and effective enough to study further — given that, do you think the potential unknowns outweigh sticking with standard Alzheimer's treatments for now?
3The trial is active but no longer enrolling new participants, so I likely can't join — but are there similar trials combining hormonal or anti-inflammatory approaches with cognitive medications that I might still be able to enroll in?
4The trial measures cognitive change using the ADAS-cog-11 scale — can you explain what that test actually measures, and how meaningful a 'percent change' on that scale would feel in day-to-day life for someone at my stage?
5Leuprolide is typically used to suppress sex hormones — what side effects should I know about from that kind of hormonal suppression, especially on top of a cholinesterase inhibitor, and would those risks be acceptable given where I am in my diagnosis?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog-11)

Timeframe: Baseline, 48 Weeks

Trial details

NCT IDNCT03649724

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-25

View on ClinicalTrials.gov More Alzheimer Disease trials