Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment

NCT ID: NCT02982603

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-12-31

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.

Conditions

Mild Cognitive Impairment; Herbal Medicine Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Qinggongshoutao Bolus

Intervention Type: DRUG

Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761

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.

Group Type: ACTIVE_COMPARATOR

Ginkgo Biloba Extract 761

Intervention Type: DRUG

Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba

Interventions

Qinggongshoutao Bolus

Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761

Intervention Type: DRUG

Ginkgo Biloba Extract 761

Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761

Intervention Type: DRUG

Placebos

Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba

Intervention Type: DRUG

Other Intervention Names

Ginkgo biloba also named Egb761 or Ginaton; Ginkgo biloba also named Egb761 or Ginaton

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Jinzhou Tian

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinzhou Tian, M.D,PhD

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Locations

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Z12020286

Identifier Type: -

Identifier Source: org_study_id