Weill Medical College of Cornell University
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.
Alzheimer Disease
Mild Cognitive Impairment
Placebo
Eligard 22.5Mg Suspension for Injection
PHASE2
This project aims to re-purpose the safe and well-tolerated gonadotropin-releasing hormone (GnRH) analogue Leuprolide Acetate for use in Alzheimer's Disease (AD). Leuprolide Acetate is currently used in adults for prostate cancer, endometriosis, uterine fibroids and in preparation for in-vitro fertilization, and in children for central precocious puberty. The purpose of this study to confirm and extend results from a prior phase II study (Bowen et al, 2015) which demonstrated that Leuprolide halted cognitive and functional decline in a subgroup of women with mild-moderate AD who were also taking the acetylcholinesterase inhibitor donepezil. Objectives are to replicate, in the same subgroup, Leuprolide's clinical EFFICACY in this prior trial and to add neuroimaging and plasma BIOMARKERS that will help elucidate Leuprolide's likely multiple mechanisms of action in AD. These mechanisms include decreasing levels of Luteinizing Hormone (LH) based on extensive preclinical evidence that decreasing LH preserves cognition and decreases amyloid deposition and tau phosphorylation in animal models of AD, as well as new evidence that GnRH analogues may have anti-inflammatory effects.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 180 participants |
Masking : | DOUBLE |
Primary Purpose : | TREATMENT |
Official Title : | The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's |
Actual Study Start Date : | 2020-11-27 |
Estimated Primary Completion Date : | 2025-12 |
Estimated Study Completion Date : | 2026-02 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 60 Years to 120 Years |
Sexes Eligible for Study: | FEMALE |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Miami Miller School of Medicine
Boca Raton, florida, United States, 33433
RECRUITING
Weill Medical College of Cornell University
New York, New York, United States, 10021
RECRUITING
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792