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

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 anddosage 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 vascularorigin

• Fluent in English

• has a study partner / caregiver who interacts with the subject for at least 5 hoursper week on average and can participate in evaluations

Exclusion Criteria:

• Presence based on exam, history or MRI of significant brain disease other than ADsuch 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 tolerateneuroimaging

• Taking other medications known to affect serum sex hormone or gonadotropinconcentrations such as estrogen and/or progesterone for hormone replacement therapy,goserelin or danazol

• Presence of significant systemic illness likely to interfere with participation inor completion of the study or to affect study results such as cancer within 5 years (other than non-melanoma skin cancer), autoimmune disease, recent myocardialinfarction, signs/symptoms of organ failure based on history, ECG, screeninglaboratory and/or physical exams

• Receiving other investigational drugs within 30 days or 5 half-lives prior torandomization, whichever is longer