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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

All Individual Drugs Already Approved

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

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I have been diagnosed with Alzheimer's disease or mild cognitive impairment due to Alzheimer's.

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I am a woman and have gone through menopause.

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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:

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I do not have any major illnesses that could affect my participation in the study.

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I am on medication that affects my hormone levels, like hormone replacement therapy.

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I do not have major brain conditions like schizophrenia, epilepsy, Parkinson's, or severe stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 48 weeks

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)

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