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ACTIVE NOT RECRUITING
NCT03649724
PHASE2

The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

60 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2020-11-27

Completion Date

2026-07-01

Last Updated

2025-08-01

Healthy Volunteers

No

Interventions

DRUG

Placebo

Placebo (0.25 ml normal saline) will be administered subcutaneously once every twelve weeks for 48 weeks.

DRUG

Eligard 22.5Mg Suspension for Injection

Eligard 22.5Mg Suspension for Injection will be administered subcutaneously, in accord with manufacturer's direction, once every twelve weeks for 48 weeks.

Locations (3)

University of Miami Miller School of Medicine

Boca Raton, Florida, United States

Weill Medical College of Cornell University

New York, New York, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States