Efficiency and safety assessment of donepezil for treating mild and moderate Alzheimer disease

Dantao PENG; Xianhao XU; Luning WANG

ABSTRACT

BACKGROUND:

As the second anti-Alzheimer disease drug approved by Food and Drug Administration(FDA), donepezil (Aricept) has been applied in European and American market. According to the regulation of Health Ministry of China, it needs conducting clinical trial of multiple center nationwide in order to come into Chinese market.

OBJECTIVE:

To evaluate the efficiency and safety of donepezil on treating mild and moderate Alzheimer disease (AD).

DESIGN:

Randomized, single blind and placebo control prospective study based on patients.

SETTING:

Neurological Department of Peking Hospital and Neurological Department of the 301 Hospital of Chinese PLA, and ect.

PARTICIPANTS:

Totally 188 patients with mild and moderate AD[with mini-mental state examination(MMSE) score of 10 to 24 points] from 15 big hospitals of Beijng, Shanghai and Guangzhou were conducted 12 weeks'clinical trial, among which 89 cases were of single blind and placebo control study while 99 cases were of self-controlled study. All the cases met the AD diagnostic standard of clinical neurology, linguistic dysfunction and stroke(NINCDS-ADRDA) and the 4th edition of Statistic Manual (DSM-IVR).

INTERVENTIONS:

Donepezil (5 rmg/tablet, ip, 5 rmg/time) or placebo with same color, shape, flavor and size with donepezil ( ip, 1 tablet/time)was taken orally for 12 consecutive weeks.MAIN OUTCOME

MEASURES:

MMSE, clinical dementia rating scale(CDR), activities of daily life scale(ADL), biochemical parameters, electrocardiograph(ECG) and chest x-ray were conducted once every 4 weeks before and after treatment.

RESULTS:

The random, single blind and placebo control study showed that the score of MMSE, CDR and ADL was greatly improved in donepezil group after 12 weeks' treatment when comparing with placebo group(P ＜ 0. 01,0.05, 0.01 ). Self-controlled study showed that the score of MMSE, CRD and ADL in donepezil group after 12 weeks' treatment increased 3.5, 0.6 and 7.1 points respectively compared with those before treatment(P ＜ 0.01,0.05, 0.01 ) . The score of MMSE was already improved in the 4th week of treatment. Among the 145 patients who took donepezil, 7 cases(4.8% )experienced side effect of mild cholinergic excitability. In the placebo group,2 of the 43 cases appeared dizziness and nausea. There was no difference between two groups( P ＞ 0.05).

CONCLUSION:

Donepezil can effectively treat mild and moderate AD patients and improve their cognitive functions, dementia level and daily living abilities with good tolerance and high safety.