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Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT02982603
Recruitment Status : Completed
First Posted : December 5, 2016
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jinzhou Tian, Dongzhimen Hospital, Beijing

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Herbal Medicine Allergy Drug: Qinggongshoutao Bolus Drug: Ginkgo Biloba Extract 761 Drug: Placebos Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Qinggongshoutao Bolus
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.
Drug: Qinggongshoutao Bolus
Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761
Other Name: Ginkgo biloba also named Egb761 or Ginaton

Active Comparator: Ginkgo Biloba Extract 761
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.
Drug: Ginkgo Biloba Extract 761
Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761
Other Name: Ginkgo biloba also named Egb761 or Ginaton

Placebo Comparator: Placebos
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.
Drug: Placebos
Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba




Primary Outcome Measures :
  1. 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. ]
  2. 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 Measures :
  1. Mini-Mental State Examination(MMSE) [ Time Frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52. ]
  2. 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. ]
  3. 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. ]


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982603


Locations
China, Beijing
Dongzhimen Hospital ,Beijing University of Chinese Medicine
Beijing, Beijing, China, 100700
Sponsors and Collaborators
Dongzhimen Hospital, Beijing
Investigators
Principal Investigator: Jinzhou Tian, M.D,PhD Dongzhimen Hospital,Beijing University of Chinese Medicine

Responsible Party: Jinzhou Tian, Clinical Professor, Dongzhimen Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02982603     History of Changes
Other Study ID Numbers: Z12020286
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: May 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Cognitive Dysfunction
Drug Hypersensitivity
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders