← Back to Search

Hormone Therapy

Leuprolide for Alzheimer's Disease (LUCINDA Trial)

Phase 2
Recruiting
Led By James E Galvin, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Probable AD or MCI due to AD according to NIA-AA criteria
Female, post-menopausal
Must not have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 48 weeks
Awards & highlights

Summary

This trial is testing whether a 48-week regimen of leuprolide acetate can improve cognitive function in women with Mild Cognitive Impairment or Alzheimer's Disease.

Who is the study for?
The LUCINDA Trial is for post-menopausal women fluent in English with Mild Cognitive Impairment or Alzheimer's Disease, already taking a stable dose of cholinesterase inhibitors like donepezil. Participants must have a caregiver and meet specific cognitive criteria without significant brain disease other than AD, recent substance abuse, or serious systemic illness.
What is being tested?
This trial tests the effect of leuprolide acetate (Eligard) on cognitive function in women with Alzheimer's or MCI over 48 weeks. It compares Eligard injections every 12 weeks against placebo while participants continue their usual cholinesterase inhibitor medication.
What are the potential side effects?
Potential side effects from Eligard may include hot flashes, headaches, joint pain, sweating episodes, sleep problems and mood changes. Since it affects hormone levels, it might also impact bone density.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Alzheimer's disease or mild cognitive impairment due to Alzheimer's.
Select...
I am a woman and have gone through menopause.
Select...
I am on a steady dose of medication like Aricept for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any major illnesses that could affect my participation in the study.
Select...
I am on medication that affects my hormone levels, like hormone replacement therapy.
Select...
I do not have major brain conditions like schizophrenia, epilepsy, Parkinson's, or severe stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog-11)
Secondary study objectives
Alzheimer Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC+)
Change in Brain Magnetic Resonance Imaging (MRI) biomarkers
Percent change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LeuprolideExperimental Treatment1 Intervention
Eligard 22.5mg administered subcutaneously / 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
0.25 ml of sterile normal saline administered subcutaneously / 12 weeks

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,823 Total Patients Enrolled
Tolmar PharmaceuticalsUNKNOWN
Weill Medical College of Cornell UniversityLead Sponsor
1,077 Previous Clinical Trials
1,320,487 Total Patients Enrolled

Media Library

Leuprolide acetate (Eligard) (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03649724 — Phase 2
Alzheimer's Disease Research Study Groups: Leuprolide, Placebo
Alzheimer's Disease Clinical Trial 2023: Leuprolide acetate (Eligard) Highlights & Side Effects. Trial Name: NCT03649724 — Phase 2
Leuprolide acetate (Eligard) (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03649724 — Phase 2
~42 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top