DL-3-n-butylphthalide Treatment in Patients With Mild to Moderate Alzheimer's Disease Already Receiving Donepezil
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      Alzheimer's disease (AD) is the commonest cause of dementia. There is no effective treatment
      to cure the disease. Cholinesterase inhibitors, such as donepezil, are widely recommended to
      patients with mild to moderate AD. But the cognitive function of most of the patients using
      donepezil gradually aggravate, with Mini-Mental State Examination(MMSE) score falling by 2
      points per year on average, and donepezil cannot effectively delay AD progress.

      DL-3-n-butylphthalide(NBP) is a synthetic chiral compound containing L- and D-isomers of
      butylphthalide. It is developed from L-3-n-butylphthalide, which was initially isolated as a
      pure component from seeds of Apium graveolens in 1978 by researchers of Institute of Medicine
      of Chinese Academy of Medical Sciences. Studies in the past several decades have demonstrated
      that NBP is effective in alleviating oxidative damage and mitochondria dysfunction, improving
      microcirculation. NBP was approved by the State Food and Drug Administration of China (SFDA)
      as a therapeutic drug for treatment of ischemic stroke in 2005 Not only for ischemic stroke,
      NBP has been reported to increase the expression of N-methyl-D-aspartate subtype glutamate
      receptor 2B(NR2B) and synaptophysin in hippocampus of aged rats after chronic cerebral
      hypoperfusion and increasing brain acetylcholine level, which are important processes
      involved in learning and memory. It could alleviate the learning and memory deficits induced
      by cerebral ischemia in rats. A multicentre, randomized, double-blind, placebo-controlled
      trial conducted by Professor Jia investigated that NBP was effective for improving cognitive
      and global functioning in patients with subcortical vascular cognitive impairment without
      dementia and exhibited good safety over the 6-month treatment period. The pathogenesis of AD
      involved mitochondria dysfunction and microcirculation dysfunction, which are the action
      targets of NBP. Investigators observed that MMSE score lowering slowly when using NBP
      treatment in patients with mild to moderate AD already receiving donepezil. But investigators
      lack of system evaluation and follow-up. Hence, investigators hypothesized that NBP may have
      therapeutic efficacy for patients with AD and designed the present study.
    


Intervention name(s): DL-3-n-butylphthalide; Donepezil
Intervention type(s): Drug; Drug
Intervention description(s): the patients with mild to moderate AD have already been prescribed the drugs,we just observed passively.; the patients with mild to moderate AD have already been prescribed the drugs,we just observed passively.
Other intervention name(s): NBP; Aricept
Intervention MeSH terms: 3-n-butylphthalide; Donepezil
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients With Mild to Moderate Alzheimer's Disease Already Receiving Donepezil