P2-032: the effectiveness of step regimen for alzheimer's disease in cognition and behavior: a real-world study

Conventional therapy (CT), such as donepezil and memantine, is well- known symptomatic treatments for Alzheimer's disease (AD). The improved cognition, however, dropped below baseline level after 9 months’ treatment. We conducted an observational study to see whether the STEP regimen, a sequential therapy based on the evolvement of pattern defined by traditional Chinese medicine, combined with CT (CT+STEP) is better than CT alone (CT-STEP). This is a real-world study in which all participants were sampled in memory clinics at local hospitals. AD patients involved were selected from the outpatient registration systems. In CT+STEP group, donepezil was used for mild to severe AD patients but memantine for moderate and severe AD patients, meanwhile plus the STEP regimen. Outcome measures included mini-mental state examination (MMSE), neuropsychiatric inventory (NPI), activities of daily living (ADLs) as well as clinical dementia rating (CDR). A total of 162 AD patients with baseline data were involved, of which 110 received the CT+STEP. At 12 months, the MMSE remained stable in the CT+STEP group, while the CT-STEP group showed a significant decrease, with a 4.00 points of difference from baseline (95% CI: 2.53 to 5.46, P < 0.001) and a 3.54 points of difference between two groups (95%CI: 1.77 to 5.32, P < 0.001). In the first 6 months of treatment, there was no significant difference in NPI between the two groups, but at 9 and 12 months, significant differences were found (4.76, 95%CI: −0.08 to 9.62, P=0.001) and 3.89 (95%CI: −1.60 to 9.39, P= 0.003), respectively, which appeared to be time-dependent.