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Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment, Herbal Medicine Allergy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Qinggongshoutao Bolus
Ginkgo Biloba Extract 761
Placebos
Sponsored by
Dongzhimen Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. cognitive complaints from the patients or their families;
  2. objective evidence for memory impairment, delayed story recall test(DSR)<12.6(age50-64 less than15.5,65-74less than 12.5,older 75 less than10);
  3. normal general cognitive function, with Mini-Mental State Examination (MMSE) score of between 24 and 30 (including 30);
  4. preservation of activities of daily living, with Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) score between 38 and 52;
  5. cognitive disorders as evidenced by clinical evaluation, with clinical dementia rating scale=0.5,memory domain = 0.5;
  6. absence of dementia, not sufficiently impaired cognitively and functionally to meet DSM-IV criteria,
  7. enough vision and hearing to accomplishment neuropsychological test;
  8. capability to read words and write simple sentence;
  9. capability and willingness to give informed consent and to comply with the study procedures.

Exclusion Criteria:

  1. non amnestic Mild cognitive impairment;
  2. meeting the diagnostic criteria for dementia;
  3. cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, epilepsy vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor ,or drug abuse or alcohol abuse
  4. having significant psychiatric disease, depression, the Hamilton depression scale >12; CT or MRI scan showed central nervous system infections Infarction or focal lesions within 12 months，the Hachinski Ischemic Scale (HIS)>4;
  5. combined following disease: diabetes; poor controlled hypertension or severe arrhythmias; or suffered from heart infarction within 3 months; severe asthma or COPD; severe indigestion; gastrointestinal tract obstruction; gastroduodenal ulcer;
  6. used cholinesterase inhibitors or memantine within 1 month;
  7. history of hypersensitivity to the treatment drugs;
  8. concomitant drugs with the potential to interfere with cognition;
  9. administration of other investigational drugs; severe impairment of the functions of the kidney or liver;
  10. vegetarians or contraindications for animal innards.

Sites / Locations

  • Dongzhimen Hospital ,Beijing University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Qinggongshoutao Bolus

Ginkgo Biloba Extract 761

Placebos

Arm Description

Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761 .Qinggongshoutao bolus 70 pills every time (7g), 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.

Ginkgo Biloba Extract 761 and placebo identified to Qinggongshoutao bolus.The subjects will take Ginkgo Biloba Extract 761 2 times per day, 2 pills per time(80mg) ,and identified to Qinggongshoutao bolus 70 pills every time, 2 times per day for 48 weeks.

Placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761.Placebo identified to Qinggongshoutao bolus 70 pills every time, 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.

Outcomes

Primary Outcome Measures

Change from baseline to end of double-blind treatment of Alzheimer Disease Assessment Scale-cognitive subscale
Change from baseline to end of double-blind treatment of rate of conversion to dementia

Secondary Outcome Measures

Mini-Mental State Examination(MMSE)
Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR)
Change from baseline to end of double-blind treatment of Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24)

Full Information

First Posted
November 30, 2016
Last Updated
October 22, 2018
Sponsor
Dongzhimen Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT02982603
Brief Title
Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment
Official Title
The Efficacy and Safety of Qinggongshoutao Bolus for aMnestic Mild Cognitive Impairment: A 52- Week Randomized, Double-blind, Controlled,Three Arms, Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongzhimen Hospital, Beijing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel controlled phase VI trial being carried out in 20 centers around China. The study population includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2 times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton) (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a 52-weeks double-blind treatment period. The primary outcome measure is change from baseline in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is being assessed by observing side effects and adverse reaction during the entire treatment period. Statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Herbal Medicine Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Qinggongshoutao Bolus
Arm Type
Experimental
Arm Description
Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761 .Qinggongshoutao bolus 70 pills every time (7g), 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.
Arm Title
Ginkgo Biloba Extract 761
Arm Type
Active Comparator
Arm Description
Ginkgo Biloba Extract 761 and placebo identified to Qinggongshoutao bolus.The subjects will take Ginkgo Biloba Extract 761 2 times per day, 2 pills per time(80mg) ,and identified to Qinggongshoutao bolus 70 pills every time, 2 times per day for 48 weeks.
Arm Title
Placebos
Arm Type
Placebo Comparator
Arm Description
Placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761.Placebo identified to Qinggongshoutao bolus 70 pills every time, 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Qinggongshoutao Bolus
Other Intervention Name(s)
Ginkgo biloba also named Egb761 or Ginaton
Intervention Description
Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761
Intervention Type
Drug
Intervention Name(s)
Ginkgo Biloba Extract 761
Other Intervention Name(s)
Ginkgo biloba also named Egb761 or Ginaton
Intervention Description
Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba
Primary Outcome Measure Information:
Title
Change from baseline to end of double-blind treatment of Alzheimer Disease Assessment Scale-cognitive subscale
Time Frame
week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.
Title
Change from baseline to end of double-blind treatment of rate of conversion to dementia
Time Frame
week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.
Secondary Outcome Measure Information:
Title
Mini-Mental State Examination(MMSE)
Time Frame
week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.
Title
Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR)
Time Frame
week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.
Title
Change from baseline to end of double-blind treatment of Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24)
Time Frame
week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cognitive complaints from the patients or their families; objective evidence for memory impairment, delayed story recall test(DSR)<12.6(age50-64 less than15.5,65-74less than 12.5,older 75 less than10); normal general cognitive function, with Mini-Mental State Examination (MMSE) score of between 24 and 30 (including 30); preservation of activities of daily living, with Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) score between 38 and 52; cognitive disorders as evidenced by clinical evaluation, with clinical dementia rating scale=0.5,memory domain = 0.5; absence of dementia, not sufficiently impaired cognitively and functionally to meet DSM-IV criteria, enough vision and hearing to accomplishment neuropsychological test; capability to read words and write simple sentence; capability and willingness to give informed consent and to comply with the study procedures. Exclusion Criteria: non amnestic Mild cognitive impairment; meeting the diagnostic criteria for dementia; cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, epilepsy vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor ,or drug abuse or alcohol abuse having significant psychiatric disease, depression, the Hamilton depression scale >12; CT or MRI scan showed central nervous system infections Infarction or focal lesions within 12 months，the Hachinski Ischemic Scale (HIS)>4; combined following disease: diabetes; poor controlled hypertension or severe arrhythmias; or suffered from heart infarction within 3 months; severe asthma or COPD; severe indigestion; gastrointestinal tract obstruction; gastroduodenal ulcer; used cholinesterase inhibitors or memantine within 1 month; history of hypersensitivity to the treatment drugs; concomitant drugs with the potential to interfere with cognition; administration of other investigational drugs; severe impairment of the functions of the kidney or liver; vegetarians or contraindications for animal innards.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinzhou Tian, M.D,PhD
Organizational Affiliation
Dongzhimen Hospital, Beijing University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongzhimen Hospital ,Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment

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