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

Active Not RecruitingPhase 2

Sponsor: Weill Medical College of Cornell University

Conditions: Alzheimer Disease, Mild Cognitive Impairment

Interventions: Placebo, Eligard 22.5Mg Suspension for Injection

Countries: United States

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 overview

Sex: FEMALE

Age: 60 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 \<5 supporting clinical judgment that dementia is not of vascular origin
* Fluent in English
* has a study partner / caregiver who interacts with the subject for at least 5 hours per week on average and can participate in evaluations

Exclusion Criteria:

* Presence based on exam, history or MRI of significant brain disease other than AD such as schizophrenia, epilepsy, Parkinson's disease or large territory stroke
* Current substance abuse in accord with DSM V criteria
* Significantly depressed (Geriatric Depression Scale \> 10)
* Physical or psychological MRI contraindications, or likely unable to tolerate neuroimaging
* Taking other medications known to affect serum sex hormone or gonadotropin concentrations such as estrogen and/or progesterone for hormone replacement therapy, goserelin or danazol
* Presence of significant systemic illness likely to interfere with participation in or completion of the study or to affect study results such as cancer within 5 years (other than non-melanoma skin cancer), autoimmune disease, recent myocardial infarction, signs/symptoms of organ failure based on history, ECG, screening laboratory and/or physical exams
* Receiving other investigational drugs within 30 days or 5 half-lives prior to randomization, whichever is longer

Locations (3)

Boca Raton, Florida, United States
New York, New York, United States
Madison, Wisconsin, United States