Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 2
Funding Agency/Sponsor
Other
Disease
Memory Disorders
Enrollment Eligibility
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
- Ever treated with active or passive immunization for AD (e.g. Lecanemab) due to
unknown alterations in systemic and brain inflammation, which may confound results