Efficacy and Safety Study of Shenwu Capsule
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Intervention: Shenwu Capsule; Donepezil
Intervention description: 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.
Intervention MeSH terms: Donepezil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 324.0
Sex: All
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Mild cognitive impairment

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese-speaking adults at least 55 to 80 years of age old, weighting between 45 to 90
             kilograms, living in the community.

          -  diagnosed with amnestic MCI at screening: (1) memory complaint, corroborated by an
             informant; (2) abnormal memory function, as screened by the WMS-R Logical Memory II
             Delayed Story Recall subtest score <10.4 for age; (3) normal general cognitive
             function, as determined by a clinician's judgment based on a structured interview with
             the patients (MMSE of 24 to 30 score for education ); (4) no or minimal impairment in
             activities of daily living, as determined by a clinical interview with the patient and
             informant (IADL <16 score); and (5) not sufficiently impaired, cognitively and
             functionally, to meet NINCDS-ADRDA criteria for AD, as judged by an experienced AD
             research clinician. In addition, they were judged to be at stage 2-3 of the GDS, and
             to have a score of ≤12 of the HAMD for 17 items, of ≤4 on the HIS, and no or minimal
             medial temporal atrophy (MTA) or hippocampal volume atrophy on the MRI scan.

          -  The subjects required adequate vision and hearing to participate in study assessments.
             Patients receiving chronic aspirin therapy for cardio-protection (≤100 mg per day) or
             stable doses of antidepressants for at least 3 months were also eligible.

        Exclusion Criteria:

          -  Significant neurologic disease that might affect cognition, such as a diagnosis of
             Alzheimer's disease, stroke, Parkinson's disease, multiple sclerosis, or severe head
             injury with loss of consciousness; a score of MMSE<24,or any major psychiatric
             disorder (e.g., DSM-IV-defined psychosis, major depression, bipolar disorder, or
             alcohol or substance abuse);

          -  Recent history of chronic use of NSAIDs or aspirin (>100 mg per day);

          -  History of upper gastrointestinal bleeding that required transfusion or surgery within
             the previous 3 years,or documented evidence of an active gastric or duodenal ulcer
             within the previous 3 months,or history of NSAID-associated ulcers;

          -  History of active malignancy except for basal cell carcinoma or squamous cell
             carcinoma of the skin, or prostate cancer, within the preceding 24 months;

          -  A chronic or acute renal, hepatic, or metabolic disorder; and uncontrolled
             hypertension and diabetes mellitus;

          -  History of hypersensitivity to the treatment drugs; or concomitant drugs (including
             anticonvulsant agents, anti-parkinsonian agents, antipsychotics, anxiolytics, hypnotic
             agents, neuroleptic agents, cholinomimetic agents, vitamin E, or ginkgo biloba extract
             or any other drugs including traditional Chinese herbal medicines which can affect
             memory); or participants in other clinical studies within the past 30 days.