Efficacy and Safety Study of Shenwu Capsule
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this phase III study is to further evaluate the effects of shenwu capsule, a
      traditional Chinese herbal medicine, on cognition, function and memory in patients with
      amnestic mild cognitive impairment (MCI) who are at greater risk for developing Alzheimer's
      disease, in a 6-month supervised protocol of a traditional Chinese herbal medicine. The
      results of this study may provide support for a relatively simple and inexpensive treatment
      strategy with herbal therapy that specifically targets individuals with the mild cognitive
      impairment that directly influence risk of developing dementia for older adults.
    

Detailed description: 
      Mild cognitive impairment (MCI) refers to a group of individuals who have some cognitive
      impairment but of insufficient severity to constitute dementia1,which is a transitional stage
      between normal aging and dementia. Amnestic MCI is the most common subtype of MCI, which
      shows the least reversion to normal, and is defined as a significant impairment in memory but
      with no impairment in activities of daily living. In an interventional study of patients
      meeting Petersen criteria for amnestic MCI, 16% progressed to dementia per year, 99% of whom
      received an AD diagnosis. Hence, MCI, in particular amnestic MCI is generally recognized in
      many cases to represent prodromal AD and becomes a new target for prevention and treatment of
      AD.

      The specific aims for the study is to evaluate change in Efficacy and safety of shenwu
      capsule in treating amnestic MCI. Using a randomized controlled parallel group design, 324
      older adults diagnosed with amnestic MCI participate in a 6-month supervised protocol of
      either shenwu capsule or donepezil. Cognitive testing and blood collection will occur at
      baseline, and months 3 and 6. Before the 6-month intervention, medial temporal atrophy (MTA)
      or hippocampal volume atrophy on the CT or MRI scan are assessed for all subjects. The
      results of this study may provide support for a safer and inexpensive treatment strategy that
      specifically targets individuals with the mild cognitive impairment that directly influence
      risk of developing dementia for older adults.
    

Intervention name(s): Shenwu Capsule; Donepezil
Intervention type(s): Drug; Drug
Intervention description(s): 1 shenwu capsule contains 451 mg extract from herbs.5 capsules/time, 3 times/day for 6 months.
Placebo identified to donepezil: 1 tablet per time, 1 time per day for 6 months.; This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.
Placebo identical to shenwu capsules,5 capsules/time,3times/day for 6months.
Other intervention name(s): Shenwu; Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild cognitive impairment