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

What Was Tested

This registered phase 2 trial tested Leuprolide.

It had two arms (groups): Placebo (placebo comparator) and Leuprolide (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 86 actual participants took part.

It was open to women only aged from 60 years up to 120 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Probable AD or MCI due to AD according to NIA-AA criteria. 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.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: current substance abuse in accord with dsm v criteria; 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; receiving other investigational drugs within 30 days or 5 half-lives prior to randomization, whichever is longer.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-11-27 with completion listed for 2026-07-25.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog-11) (time frame: Baseline, 48 Weeks).

It also tracked 6 secondary outcomes, for example Alzheimer Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC+), Percent change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Percent change in Burden Inventory and Percent change in Neuropsychiatric Inventory (NPI).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 86 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.