Phase 3
Completed N=324
Efficacy and Safety Study of Shenwu Capsule
Source: ClinicalTrials.gov NCT01451749 ↗Enrolled (actual)
324
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog) — -4.23; -4.31 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog) |
-4.23; -4.31 | — |
| SECONDARY Change in Memory Scores: The Delayed Story Recall (DSR) Test From the Adult Memory and Information Processing Battery (AMIPB) |
9.45; 9.9 | — |
| SECONDARY Change in Functional Scores: Instrumental Activities of Daily Living (IADL). |
0.96; 1.18 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT01451749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.