The Efficacy and Safety of Qinggongshoutao Bolus for aMnestic Mild Cognitive Impairment: A 52- Week Randomized, Double-blind, Controlled,Three Arms, Multi-center Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Change from baseline to end of double-blind treatment of Alzheimer Disease Assessment Scale-cognitive subscale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Qinggongshoutao Bolus (Drug)
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.
Intervention: Ginkgo Biloba Extract 761 (Drug)
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.
Intervention: Placebos (Drug)
Outcomes
Primary Outcomes
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.
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 Outcomes
- Mini-Mental State Examination(MMSE)(week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.)
- 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)(week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.)
- Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR)(week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.)
Investigators
Jinzhou Tian
Clinical Professor
Dongzhimen Hospital, Beijing