Overview

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