OBJECTIVE
To evaluate the clinical efficacy and safety of huperzine Alpha in treatment of patients with mild to moderate Alzheimer disease (AD).
METHODS
Two hundred and two patients with the diagnosis of possible or probable AD from 15 centers the nationwide were randomly divided into two groups: huperzine Alpha group (n = 100, given huperzine Alpha 400 micro g/day for 12 weeks) and placebo group (n = 102 ). Different scales were used to evaluate the cognitive function, activity of daily life (ADL), non-cognitive disorders, and overall clinical efficacy. Safety evaluation was conducted every 6 weeks.
RESULTS
In comparison with the baseline data, there was an improvement of 4.6 points in cognition assessed by ADAS-Cog (P = 0.000); an improvement of 2.7 points by MMSE (P = 0.000), an improvement of 1.5 points in behavior and mood by ADAS-non-Cog (P = 0.008) with 59.2% of the patients being on the mend clinically; and an improvement of 2.4 points by ADL (P = 0.001) with the capacity of ADL improved by at least 10% among 32.75% of the patients. 70% of the patients in huperzine Alpha group scored 1 approximately 3 points, and 27.8% of them scored 1 approximately 2 points by CIBIC-plus. The proportions of patients with an improvement of >/= 4 points by ADAS-Cog were 56.1% and 12.5% in the huperzine Alpha group and placebo group respectively (P = 0.000). The proportions of patients with an improvement of >/= 4 points by MMSE were 37.8% and 10.1% in the huperzine Alpha group and placebo group respectively (P = 0.000). The proportions of patients with an improvement of 1 approximately 3 points in global rating by CIBIC-plus were 59.2% and 40.6% in the huperzine Alpha group and placebo group respectively (P = 0.01). The proportions of patients with an improvement of >/= 10% points by ADL were 32.7% and 17.2% in the huperzine Alpha group and placebo group respectively (P = 0.01). The proportions of patients with an improvement of > 0 points by ADS-non-C0g were 70.0% and 36.3% in the huperzine Alpha group and placebo group respectively (P = 0.000). Mild and transient adverse events (edema of bilateral ankles and insomnia) were observed in 3% of huperzine Alpha treated patients.
CONCLUSION
A safe and effective medicine, huperzine Alpha remarkably improves the cognition, behavior, ADL,and mood of AD patients.