Leuprolide for Alzheimer's Disease
(LUCINDA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires participants to continue taking a stable dose of a cholinesterase inhibitor medication like donepezil. However, you cannot take medications that affect hormone levels, such as estrogen or progesterone.
How does the drug Leuprolide acetate differ from other Alzheimer's treatments?
Who Is on the Research Team?
Craig S Atwood, PhD
Principal Investigator
University of Wisconsin, Madison
James E Galvin, MD
Principal Investigator
University of Miami
Tracy A Butler, MD
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive leuprolide acetate or placebo every 12 weeks for a total of 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Leuprolide acetate (Eligard)
- Placebo
Leuprolide acetate (Eligard) is already approved in United States, European Union, Canada for the following indications:
- Prostate cancer
- Endometriosis
- Precocious puberty
- Prostate cancer
- Endometriosis
- Precocious puberty
- Uterine fibroids
- Prostate cancer
- Endometriosis
- Precocious puberty
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Tolmar Pharmaceuticals
Collaborator