Patients were eligible for enrollment if they met standard clinical criteria for dementia that was probably due to AD (biomarker tests were not required for patient inclusion) [35 , 36 (link)], had a baseline MMSE score of 12 to 25 (corresponding to mild or moderate dementia), had been treated with a cholinesterase inhibitor, memantine, or both, (representing the standard of care) for a minimum of 6 months prior to screening, and were at least 50 years old. Exclusion criteria included any other cause of dementia not due to AD, severe forms of delusions or delirium, presence of infection, evidence/history of significant psychiatric disorder, and treatment with registered or putative cognitive/memory enhancer or disease modifier (other than donepezil, galantamine, rivastigmine or memantine).
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