Mild Cognitive ImpairmentPhase 3NCT01451749

Efficacy and Safety Study of Shenwu Capsule

A Phase 3 study testing Shenwu Capsule and Donepezil in people with Mild Cognitive Impairment, run by North China Pharmaceutical Group Corporation at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 80 years
Conditions the study is for: Mild Cognitive Impairment
What is being tested?: Shenwu Capsule and Donepezil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 324 participants
Where: 1 siteChina
Study dates: Sep 2008to May 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Dongzhimen Hospital,BUCM
Beijing, 100700

Other trials in China

About this study

Official title: Phase III Study of Shenwu Capsule in Treating Amnestic Mild Cognitive Impairment

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.

Read the 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.

Conditions: Mild Cognitive Impairment
Being tested: Shenwu Capsule, Donepezil
Keywords: Mild cognitive impairment
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Shenwu CapsuleDrug
Also called Shenwu
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.
DonepezilDrug
Also called Aricept
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.

Study groups in NCT01451749
Study group	Role	What they receive
Shenwu Capsule	Experimental	Shenwu Capsule:1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months. Placebo: Placebo identical to donepezil tablets,1 placebo tablet/time, 1 time/day for 6 months. Receives: Drug: Shenwu Capsule
Donepezil	Active comparator	Donepezil: 1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months. Placebo: Placebo identical to shenwu capsules,5 placebo capsules/time,3 times/day for 6 months Receives: Drug: Donepezil

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog)
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.
Measured: baseline and 24 weeks

Secondary outcomes (2)

Change in Memory Scores: The Delayed Story Recall (DSR) Test From the Adult Memory and Information Processing Battery (AMIPB)
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.
Measured: Baseline and 24 weeks
Change in Functional Scores: Instrumental Activities of Daily Living (IADL).
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.
Measured: Baseline to weeks 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008May 2010

First posted14 Oct 2011 (estimated)
Study startSep 2008
Primary completionMay 2009
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 324 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01451749
Sponsor's protocol ID: SFDA2001ZL116-SW
Other IDs: NorthChinaPGC
Status last verified: Oct 2014
First submitted: 11 Oct 2011
Last updated: 10 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Tian J, Shi J, Li T, Li L, Wang Z, Li X, Lv Z, Zheng Q, Wei M, Wang Y. Efficacy and Safety of an Herbal Therapy in Patients with Amnestic Mild Cognitive Impairment: A 24-Week Randomized Phase III Trial. Evid Based Complement Alternat Med. 2017;2017:4251747. doi: 10.1155/2017/4251747. Epub 2017 May 17.
PubMed 28596794

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Study of Shenwu Capsule in Treating Amnestic Mild Cognitive Impairment
ClinicalTrials.gov ID: NCT01451749
Acronym / sponsor ID: SFDA2001ZL116-SW
Conditions: Mild Cognitive Impairment
Keywords: Mild cognitive impairment
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 324 participants (actual)
Lead sponsor: North China Pharmaceutical Group CorporationIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: May 2009 (actual)
Study completion: May 2010 (actual)
First posted: 14 Oct 2011 (estimated)
Results: Posted 10 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Shenwu Capsule	Experimental	Drug: Shenwu CapsuleShenwu Capsule:1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months. Placebo: Placebo identical to donepezil tablets,1 placebo tablet/time, 1 time/day for 6 months.
Donepezil	Active comparator	Drug: DonepezilDonepezil: 1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months. Placebo: Placebo identical to shenwu capsules,5 placebo capsules/time,3 times/day for 6 months

Who may qualify

Ages: 55 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Shenwu CapsuleAlso: Shenwu1 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.	Drug	Shenwu Capsule
DonepezilAlso: AriceptThis 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.	Drug	Donepezil

Primary outcome

Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog)
Time frame: baseline and 24 weeks
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.

2 secondary outcomes

Change in Memory Scores: The Delayed Story Recall (DSR) Test From the Adult Memory and Information Processing Battery (AMIPB)
Time frame: Baseline and 24 weeks
Change in Functional Scores: Instrumental Activities of Daily Living (IADL).
Time frame: Baseline to weeks 24

Results and safety

Results posted to the registry on 10 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Shenwu Capsule	216	184
Donepezil	108	94

Primary outcome: Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog)

Time frame: baseline and 24 weeks. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Shenwu Capsule n = 215	Donepezil n = 107
Value	-4.23 (-4.71 to -3.75)	-4.31 (-4.99 to -3.63)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to weeks 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Shenwu Capsule	0 of 216 (0%)	39 of 216 (18.1%)	Not reported
Donepezil	0 of 108 (0%)	62 of 108 (57.4%)	Not reported

Limitations and caveats (from the sponsor): First, there was no placebo group. As all subjects knew that they were being treated with one of two drugs, and all of the individuals who assessed the patients knew this as well, the results may have been influenced by a positive response bias.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28596794Tian J, Shi J, Li T, Li L, Wang Z, Li X, Lv Z, Zheng Q, Wei M, Wang Y. Efficacy and Safety of an Herbal Therapy in Patients with Amnestic Mild Cognitive Impairment: A 24-Week Randomized Phase III Trial. Evid Based Complement Alternat Med. 2017;2017:4251747. doi: 10.1155/2017/4251747. Epub 2017 May 17.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jinzhou Tian, MD,PhD study chair

Dongzhimen Hospital, Beijing

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Shenwu Capsule and Donepezil in people with Mild Cognitive Impairment, run by North China Pharmaceutical Group Corporation at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog) (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01451749, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2014.