Trial Outcomes & Findings for Efficacy and Safety Study of Shenwu Capsule (NCT NCT01451749)
NCT ID: NCT01451749
Last Updated: 2014-10-10
Results Overview
Cognition was assessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) , at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24. The ADAS-cog was designed specifically to evaluate the severity of cognitive dysfunctions characteristic of AD patients and includes 11 items. Among these items, memory, orientation, language function, practical ability, and attention are evaluated. The score on the ADAS-cog range from 0 to 70 point, with 0 point indicating no impairment and 70 points indicating severe impairment of cognition. In the Shenwu capsule group, the ADAS-cog score is ranges 3-38.3 points, and 3.3-30.7 points in the Donepezil group. The Change in cognitive scores was calculated as24 week minus the baseline.
COMPLETED
PHASE3
324 participants
baseline and 24 weeks
2014-10-10
Participant Flow
9 sites in China were conducted patients from September 1, 2008, to May 3, 2010.The 9 sites was medical clinic in hospital.
Participant milestones
| Measure |
Shenwu Capsule
Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
|
Donepezil
Donepezil: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
216
|
108
|
|
Overall Study
COMPLETED
|
184
|
94
|
|
Overall Study
NOT COMPLETED
|
32
|
14
|
Reasons for withdrawal
| Measure |
Shenwu Capsule
Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
|
Donepezil
Donepezil: 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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
14
|
7
|
|
Overall Study
Lost to Follow-up
|
15
|
5
|
|
Overall Study
Meet the exclusion criteria,and
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Shenwu Capsule
Baseline characteristics by cohort
| Measure |
Shenwu Capsule
n=215 Participants
Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
|
Donepezil
n=107 Participants
Donepezil: 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.
|
Total
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.67 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
63.80 years
STANDARD_DEVIATION 8.25 • n=7 Participants
|
62.97 years
STANDARD_DEVIATION 8.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
215 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
215 participants
n=5 Participants
|
107 participants
n=7 Participants
|
322 participants
n=5 Participants
|
|
Mini-mental state examinition
|
27.38 units on a scale
n=5 Participants
|
27.11 units on a scale
n=7 Participants
|
27.30 units on a scale
n=5 Participants
|
|
Education
Primary school
|
40 participants
n=5 Participants
|
26 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Education
Longer than middle school
|
175 participants
n=5 Participants
|
81 participants
n=7 Participants
|
256 participants
n=5 Participants
|
|
Global Deterioration Scale
Stage 1
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Global Deterioration Scale
Stage 2
|
101 participants
n=5 Participants
|
47 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
Global Deterioration Scale
Stage 3
|
114 participants
n=5 Participants
|
59 participants
n=7 Participants
|
173 participants
n=5 Participants
|
|
Hamilton depression rating scale
|
6.44 units on a scale
n=5 Participants
|
6.39 units on a scale
n=7 Participants
|
6.40 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 24 weeksPopulation: the analyses for efficacy were conducted in the intent-to-treat population (ITT). The intent-to-treat population (ITT) consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.
Cognition was assessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) , at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24. The ADAS-cog was designed specifically to evaluate the severity of cognitive dysfunctions characteristic of AD patients and includes 11 items. Among these items, memory, orientation, language function, practical ability, and attention are evaluated. The score on the ADAS-cog range from 0 to 70 point, with 0 point indicating no impairment and 70 points indicating severe impairment of cognition. In the Shenwu capsule group, the ADAS-cog score is ranges 3-38.3 points, and 3.3-30.7 points in the Donepezil group. The Change in cognitive scores was calculated as24 week minus the baseline.
Outcome measures
| Measure |
Shenwu Capsule
n=215 Participants
Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
|
Donepezil
n=107 Participants
Donepezil: 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.
|
|---|---|---|
|
Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog)
|
-4.23 units on a scale
Interval -4.71 to -3.75
|
-4.31 units on a scale
Interval -4.99 to -3.63
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: The efficacy measurement was conducted of ITT patients. The intent-to-treat population (ITT) consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.
memory function was evaluated with the DSR subtest,at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24). The DSR is a tool which was designed to assess immediate registration of verbal information and retention over time. It contains six sub-tests: two verbal memory tests (one of which is a story recall), two visual memory tests and two information-processing tests. The story recall test includes immediate story recall (ISR) and delayed story recall (DSR). The DSR total score ranges from 0-56 points. Lowers score means higher impairment of memory.The Change in cognitive scores was calculated as 24 week minus the baseline.
Outcome measures
| Measure |
Shenwu Capsule
n=215 Participants
Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
|
Donepezil
n=107 Participants
Donepezil: 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.
|
|---|---|---|
|
Change in Memory Scores: The Delayed Story Recall (DSR) Test From the Adult Memory and Information Processing Battery (AMIPB)
|
9.45 units on a scale
Interval 8.5 to 10.4
|
9.9 units on a scale
Interval 8.49 to 11.34
|
SECONDARY outcome
Timeframe: Baseline to weeks 24Population: The efficacy measurement were conducted in the intent-to-treat population, the ITT consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.
Functional ability was evaluated with the Instrumental Activities of Daily Living (IADL) IADL, at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24). The IADL contains eight items, which are the ability to use a telephone, shop, prepare food, run laundry, use modes of transportation, take responsibility for one's own medications, complete housekeeping, and handle finances,each items ranges from 1 to 4 points, 1 points means no problem, and 4 points means greater impairment in instumental acvtiveity of daily living.The total is sub of the eight items, and the total range of the IADL is 8-32 points, higher scores indicate greater impairments. The changes was calculted by weeks 24 minus baseline.
Outcome measures
| Measure |
Shenwu Capsule
n=215 Participants
Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
|
Donepezil
n=107 Participants
Donepezil: 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.
|
|---|---|---|
|
Change in Functional Scores: Instrumental Activities of Daily Living (IADL).
|
0.96 units on a scale
Interval 0.75 to 1.18
|
1.18 units on a scale
Interval 0.85 to 1.5
|
Adverse Events
Shenwu Capsule
Donepezil
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Shenwu Capsule
n=216 participants at risk
1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.
Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
|
Donepezil
n=108 participants at risk
1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.
Donepezil: 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.
|
|---|---|---|
|
Nervous system disorders
Insomnia or abnormal dreams
|
2.3%
5/216 • Baseline to weeks 24
|
16.7%
18/108 • Baseline to weeks 24
|
|
Gastrointestinal disorders
Nausea
|
2.3%
5/216 • Baseline to weeks 24
|
16.7%
18/108 • Baseline to weeks 24
|
|
Hepatobiliary disorders
Abnormalalanine aminotransferas (ALT)
|
0.46%
1/216 • Baseline to weeks 24
|
0.93%
1/108 • Baseline to weeks 24
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/216 • Baseline to weeks 24
|
0.93%
1/108 • Baseline to weeks 24
|
|
Gastrointestinal disorders
Vomit
|
0.00%
0/216 • Baseline to weeks 24
|
4.6%
5/108 • Baseline to weeks 24
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/216 • Baseline to weeks 24
|
13.0%
14/108 • Baseline to weeks 24
|
|
General disorders
Thirsty
|
6.5%
14/216 • Baseline to weeks 24
|
4.6%
5/108 • Baseline to weeks 24
|
|
General disorders
Sore throat
|
4.2%
9/216 • Baseline to weeks 24
|
0.00%
0/108 • Baseline to weeks 24
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.3%
5/216 • Baseline to weeks 24
|
0.00%
0/108 • Baseline to weeks 24
|
Additional Information
Dr.Jinzhou Tian
Dongzhimen Hospital,Beijing University of Chinese Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60