Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment

NCT02982603 | Completed Phase 4 DMC

• 1 other identifier: Z12020286
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  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

  week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.

Secondary Outcomes (3)

• 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 Delayed Story Recall test (DSR)

  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.

Study Arms (3)

Qinggongshoutao Bolus

EXPERIMENTAL

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

Ginkgo Biloba Extract 761

ACTIVE COMPARATOR

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

Placebos

PLACEBO COMPARATOR

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

Interventions

Qinggongshoutao Bolus DRUG

Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761

Also known as: Ginkgo biloba also named Egb761 or Ginaton

Qinggongshoutao Bolus

Ginkgo Biloba Extract 761 DRUG

Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761

Also known as: Ginkgo biloba also named Egb761 or Ginaton

Ginkgo Biloba Extract 761

Placebos DRUG

Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba

Placebos

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

ginaton; Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jinzhou Tian, M.D,PhD

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 5, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 23, 2018

Record last verified: 2015-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)