OBJECTIVES:  Alzheimer’s Disease (AD) is a chronic neurodegenerative disease. It is the most common cause of dementia among older adults, leading to the loss of cognitive functioning and behavioral abilities interfering with a person’s daily life and activities. The objectives of this study were 1) to identify the medicines approved for the treatment of AD by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA); 2) to find out about the use of clinical outcome assessments (COAs) in the approval process; and 3) to identify the COAs endpoint positioning. METHODS:  The EMA and FDA websites were explored to identify all medicines approved for AD. The PROLabels database, through the ePROVIDE platform, was used for labeling claim identification. All corresponding labels and reviews were reviewed for endpoint positioning. RESULTS: Generics were neither included in the list of approved products nor reviewed, since the material used for their approval is identical to the original product. The agencies approved 12 products (representing five INN, i.e., donepezil hydrochloride, galantamine hydrobromide, memantine hydrochloride, memantine hydrochloride + donepezil hydrochloride, and rivastigmine); eight products were approved by the FDA, and four by the EMA. All products were evaluated using COAs as co-primary end-points, i.e., measures of cognitive performance [(ADAS-cog, Severe Impairment Battery (SIB)], and global impression of change [Clinician Interview-Based Impression of Change-Plus (CIBIC-Plus)], or daily functioning [Modified Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer’s Disease (ADCS-ADL-sev); Behavioral Rating Scale for Geriatric Patients (BGP) - dependency subscale]. CONCLUSIONS:  COAs are of paramount importance in the evaluation of medicines approved for AD. Most of the COAs used are either performance outcome (PerfO) or clinician-reported outcome (ClinRO) measures, given that the self-evaluation by the patient is impossible.