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.
RCT Entities:
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 ADpatients.
Authors: Bruce Diamond; Susan Johnson; Kathleen Torsney; Jennifer Morodan; Brian Prokop; Dana Davidek; Patricia Kramer Journal: Drugs Aging Date: 2003 Impact factor: 3.923