Efficacy and Safety Study of Shenwu Capsule

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
North China Pharmaceutical Group Corporation
ClinicalTrials.gov Identifier:
NCT01451749
First received: October 11, 2011
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Drug: Shenwu Capsule
Drug: Donepezil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Shenwu Capsule in Treating Amnestic Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by North China Pharmaceutical Group Corporation:

Primary Outcome Measures:
  • Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog) [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change in Functional Scores: Instrumental Activities of Daily Living (IADL). [ Time Frame: Baseline to weeks 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 324
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shenwu Capsule

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

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.

Other Name: Shenwu
Active Comparator: Donepezil

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

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.

Other Name: Aricept

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451749

Locations
China
Dongzhimen Hospital,BUCM
Beijing, China, 100700
Sponsors and Collaborators
North China Pharmaceutical Group Corporation
Investigators
Study Chair: Jinzhou Tian, MD,PhD Dongzhimen Hospital, Beijing University of Chinese Medicine
  More Information

No publications provided

Responsible Party: North China Pharmaceutical Group Corporation
ClinicalTrials.gov Identifier: NCT01451749     History of Changes
Other Study ID Numbers: SFDA2001ZL116-SW, NorthChinaPGC
Study First Received: October 11, 2011
Results First Received: November 24, 2013
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by North China Pharmaceutical Group Corporation:
Mild cognitive impairment

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 27, 2015