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

• Status: Recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: Female

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 donepezil (Aricept.) 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Aging (NIA); Tolmar Pharmaceuticals
• Treatments: Leuprolide

Criteria

Inclusion Criteria:

• Female, post-menopausal

• Probable AD or MCI due to AD according to NIA-AA criteria

• Taking a stable dose of donepezil (Aricept) for at least 90 days prior to baseline, and dosage likely to remain stable throughout the trial

• not taking memantine (Namenda)

• 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

• Living at home or in a facility other than a nursing home with a caregiver who sees the patient at least three times a week for a total of at least 10 hours and can sign the consent form, accompany the patient on clinic visits, and 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

• Ever treated with active or passive immunization as part of a different clinical trial for AD due to unknown alterations in systemic and brain inflammation, which may confound results