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

Inclusion Criteria:

- Female, post-menopausal

- Probable AD according to NIA-AA criteria41

- Amyloid PET performed at baseline visit interpreted as "amyloid present" by a board
certified nuclear medicine physician42

- Taking a stable dose of the AChEI donepezil for at least 90 days prior to baseline,
and dosage likely to remain stable throughout the trial

- Stable doses of any other medication (e.g memantine), supplement or medical food that
may affect brain function

- MMSE32 12-24 (inclusive) at screening visit

- Hachinski score43 <5 supporting clinical judgment that dementia is not of vascular
origin

- Fluent in English or Spanish

- 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 Scale44 > 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,
gosorelin 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