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Active Not Recruiting
NCT03649724
The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's
Conditions: Alzheimer Disease, Mild Cognitive Impairment
Sex: Female
Ages: 60 Years – 120 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 180
Sponsor: Weill Medical College of Cornell University
Location: University of Miami Miller School of Medicine Boca Raton Florida
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.
Eligibility Criteria
Inclusion Criteria:
* Female, post-menopausal
* Probable AD or MCI due to AD according to NIA-AA criteria
* Taking a stable dose of a cholinesterase inhibitor such as donepezil/Aricept and dosage likely to remain stable throughout the trial
* MOCA \> 11 or blind MOCA \> 8 (inclusive) at screening visit
* Hachinski score \
Source: ClinicalTrials.gov (NCT03649724). StuddyBuddy aggregates publicly available trial information.
