Last updated on February 2020

DL-3-n-butylphthalide Treatment in Patients With Mild to Moderate Alzheimer's Disease Already Receiving Donepezil

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Alzheimer's Disease
  • Age: Between 50 - 85 Years
  • Gender: Male or Female

Inclusion Criteria:

  • literate Chinese, aged 50-85 years, with a consistent caregiver who accompanied the subjects at least 4 days a week2 hours a day;
  • complaint and/or informant report of cognitive impairment involving memory and/or other cognitive domains lasting for at least 12 months; and progressing gradually.
  • diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria;
  • a mini-mental state examination (MMSE) score 11 and 22 (primary school) or 11 and 26 (junior school or above) ;
  • Hachinski ischemia scale score 4;
  • All patients meeting the clinical criteria underwent brain magnetic resonance imaging (MRI) scan including hippocampal assessment at screening. The MRI entry criteria are as follows: the number of cerebral infarcts (20 mm in diameter)less than 2, without infarcts in thalamus, hippocampal or entorhinal cortex, the medial temporal lobe atrophy visual rating scale (MTA) score more than 2 degree.
  • absent of neurological sign;
  • having used donepezil more than 3 months and remained relatively stable
  • sign the informed consent.

Exclusion Criteria:

  • severe white matter lesion(WML)(score 3 according to the Fazekas rating scale), the number of cerebral infarcts (20 mm in diameter)more than 2, with infarcts in the important sites, such as thalamus, hippocampal or entorhinal cortex;
  • dementia due to other causes, such as vascular dementia, infection of central nervous systemdementia with Lewy body(DLB)etc
  • suffered from other neurological disease, such as stroke, Parkinson's disease, epilepsy
  • suffered from mental disorders, such as schizophreniabipolar disordersevere depression, delirium;
  • suffered from unstable or severe disorders of heart, lung, liver, kidney and blood system;
  • Severe impairment of vision and hearing;
  • Using other cholinesterase inhibitors or memantine.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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