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

  • STATUS
    Recruiting
  • End date
    Feb 10, 2026
  • participants needed
    180
  • sponsor
    Weill Medical College of Cornell University
Updated on 4 October 2022
cognitive impairment
dementia
mini-mental state examination
alzheimer's disease
mild cognitive impairment
memantine
donepezil
cholinesterase
aricept

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.

Description

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.

Details
Condition Alzheimer Disease, Mild Cognitive Impairment
Treatment Placebo, Eligard 22.5Mg Suspension for Injection
Clinical Study IdentifierNCT03649724
SponsorWeill Medical College of Cornell University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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