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Could a hormone drug slow Alzheimer's? LUCINDA trial tests idea

NCT ID NCT03649724

Disease control Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether leuprolide (Eligard), a drug that lowers certain hormones, can slow memory and thinking decline in 180 women with mild Alzheimer's or mild cognitive impairment. All participants are already taking donepezil. The study compares leuprolide injections every 12 weeks against placebo for 48 weeks, measuring changes in memory tests and daily living skills.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
leuprolide (Eligard)
What this could lead to
If it works, this could point toward a new way to slow memory loss in women with early Alzheimer's.
What could go wrong
This is a small, early-phase trial with only 180 women. The drug may not improve thinking or daily function, and side effects from hormone suppression are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

86 people

The number who actually took part.

Started

Nov 2020

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 120 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Mild cognitive impairment

Contacts and locations

Locations

  • University of Miami Miller School of Medicine

    Boca Raton, Florida, 33433, United States

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792, United States

  • Weill Medical College of Cornell University

    New York, New York, 10021, United States

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