Efficacy and Safety Study of Shenwu Capsule

NCT01451749 | Completed Phase 3 Results DMC

• 2 other identifiers: SFDA2001ZL116-SWNorthChinaPGC
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive impairment

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline and 24 weeks

• Change in Functional Scores: Instrumental Activities of Daily Living (IADL).

  Baseline to weeks 24

Study Arms (2)

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.

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

Drug: Donepezil

Interventions

Shenwu Capsule DRUG

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.

Also known as: Shenwu

Shenwu Capsule

Donepezil DRUG

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.

Also known as: Aricept

Donepezil

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North China Pharmaceutical Group Corporation: lead

Study Sites (1)

Dongzhimen Hospital,BUCM

Beijing, 100700, China

Location

Related Publications (1)

• 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.

  PMID: 28596794 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

shenwu; Donepezil

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr.Jinzhou Tian
• Organization: Dongzhimen Hospital,Beijing University of Chinese Medicine

jztian@hotmail.com

86-10-84013380

Study Officials

• Jinzhou Tian, MD,PhD

  Dongzhimen Hospital, Beijing

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 14, 2011
• Study Start: September 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2010
• Last Updated: October 10, 2014
• Results First Posted: October 10, 2014

Record last verified: 2014-10

Locations

CN (1)