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Hormone Therapy

Leuprolide for Alzheimer's Disease (LUCINDA Trial)

Phase 2
Recruiting
Led By Tracy A Butler, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 48 weeks
Awards & highlights

LUCINDA Trial 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.Check my eligibility
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.See study design
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.

LUCINDA Trial 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.

LUCINDA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog-11)
Secondary outcome measures
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

LUCINDA 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?

Tolmar PharmaceuticalsUNKNOWN
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,745 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,115 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of individuals participating in this experiment?

"Affirmative, according to clinicaltrials.gov this medical trial remains open for recruitment after its initial posting on November 27th 2020 and most recent update occurring August 1st 2022. Currently the study is searching for 180 patients across 4 separate facilities."

Answered by AI

Are there any precedent research studies related to Eligard 22.5Mg Suspension for Injection?

"Currently, 64 experiments assessing Eligard 22.5Mg Suspension for Injection are in progress with 24 of them classified as Phase 3 trials. Besides the numerous sites located in Duarte, California, a total of 5355 other research centres have taken up studies on this medication across the globe."

Answered by AI

Could I potentially qualify for enrollment in this trial?

"This clinical trial seeks 180 senior citizens aged between 65 and 120 with a confirmed diagnosis of Alzheimer's disease. With regards to eligibility, the individuals must be post-menopausal females, present with a Hachinski score below 5 that indicates dementia is not of vascular origin, abstain from consuming memantine (Namenda), have a MOCA score above 11 or Blind MOCA higher than 8 at screening visit, reside at home or another facility other than nursing homes accompanied by an individual who visits them for 10 hours per week minimum and can sign consent forms as well as accompany patients during clinic visits."

Answered by AI

Is this research endeavor taking place at several locations across the state?

"At present, 4 medical centres are administering this trial; these include facilities in Boca Raton, Madison and New york City with an additional four elsewhere. To reduce travel demands for prospective participants, it is best to select the research site closest to you."

Answered by AI

For what medical issue is Eligard 22.5Mg Suspension for Injection typically prescribed?

"Eligard 22.5Mg Suspension for Injection is the standard of care when it comes to treating advanced prostate cancer, though there are other medical issues where this injection can be beneficial such as anemia and central precocious puberty."

Answered by AI

Is the criterion for eligibility to this trial restricted by age?

"The eligibility requirements for this trial necessitate that participants are between 65 and 120 years old. According to the clinical trials database, 47 studies exist for younger patients while 992 trials cater to seniors."

Answered by AI

Has Eligard 22.5Mg Suspension for Injection been accepted by the FDA?

"Our company's appraisal of Eligard 22.5Mg Suspension for Injection is a 2, as the medication has already been through Phase 2 trials showing some evidence that it is safe but none yet demonstrating its efficacy."

Answered by AI

Is this trial still open to participants?

"The details listed on clinicaltrials.gov suggest this experiment is actively recruiting volunteers; it was initially posted November 27th 2020 and its information has been revised most recently on August 1st 2022."

Answered by AI
~57 spots leftby Dec 2025