Mild Cognitive ImpairmentPhase 4NCT02982603

Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment

A Phase 4 study testing Qinggongshoutao Bolus and Ginkgo Biloba Extract 761 in people with Mild Cognitive Impairment and Herbal Medicine Allergy, run by Dongzhimen Hospital, Beijing at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 85 years
Conditions the study is for: Mild Cognitive Impairment, Herbal Medicine Allergy
What is being tested?: Qinggongshoutao Bolus and Ginkgo Biloba Extract 761
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 350 participants
Where: 1 siteChina
Study dates: May 2015to Dec 2017
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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,

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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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Dongzhimen Hospital ,Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700

Other trials in China

About this study

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

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
Being tested: Qinggongshoutao Bolus, Ginkgo Biloba Extract 761, Placebos
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Qinggongshoutao BolusDrug
Also called Ginkgo biloba also named Egb761 or Ginaton
Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761
Ginkgo Biloba Extract 761Drug
Also called Ginkgo biloba also named Egb761 or Ginaton
Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761
PlacebosDrug
Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba

Study groups in NCT02982603
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline to end of double-blind treatment of Alzheimer Disease Assessment Scale-cognitive subscale
Measured: 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
Measured: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.

Secondary outcomes (3)

Mini-Mental State Examination(MMSE)
Measured: 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)
Measured: 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)
Measured: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Dec 2017

First posted5 Dec 2016 (estimated)
Study startMay 2015
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02982603
Sponsor's protocol ID: Z12020286
Status last verified: May 2015
First submitted: 30 Nov 2016
Last updated: 23 Oct 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
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InRAD Observational Study
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All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02982603
Acronym / sponsor ID: Z12020286
Conditions: Mild Cognitive Impairment, Herbal Medicine Allergy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Dongzhimen Hospital, BeijingUniversity, hospital or other
Study start: May 2015 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 5 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Qinggongshoutao Bolus	Experimental	Drug: Qinggongshoutao BolusQinggongshoutao 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	Active comparator	Drug: Ginkgo Biloba Extract 761Ginkgo 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.
Placebos	Placebo comparator	Drug: PlacebosPlacebo 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.

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Qinggongshoutao BolusAlso: Ginkgo biloba also named Egb761 or GinatonQinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761	Drug	Qinggongshoutao Bolus
Ginkgo Biloba Extract 761Also: Ginkgo biloba also named Egb761 or GinatonPlacebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761	Drug	Ginkgo Biloba Extract 761
PlacebosPlacebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba	Drug	Placebos

Primary outcome

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.

3 secondary outcomes

Mini-Mental State Examination(MMSE)
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 Delayed Story Recall test (DSR)
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 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
Individual participant dataSharing planned: No

Related trials for Mild Cognitive Impairment

RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jinzhou Tian, M.D,PhD principal investigator

Dongzhimen Hospital, Beijing

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02982603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.