Motoric Cognitive Risk SyndromeNCT04492241
Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome
A study testing Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution and Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution in people with Motoric Cognitive Risk Syndrome and Mild Cognitive Impairment, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a multi-centre, randomised, double blind, placebo controlled study on participants with Motoric Cognitive Risk Syndrome to evaluate the efficacy and safety of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Motoric Cognitive Risk Syndrome, Mild Cognitive Impairment, Aging
- What is being tested?
- Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution and Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2021to 31 Dec 2024
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form
- Capability of independent living (capability of dressing, bathing, walking, and bed-chair transfer)
- Met Motoric Cognitive Risk Syndrome (MCR) criteria:
- Single task slow gait ( male 60 to 74 y, gait <75.4 cm/s; male ≥ 75 y, gait < 59.1 cm/s; female 60 to 74 y, gait <70.0 cm/s; female ≥ 75 y, gait < 48.3 cm/s) And The Montreal Cognitive Assessment (MoCA) ≤ 26 (≥ 12 education year) or MoCA ≤ 25 (< 12 education year)
- Anticipated good compliance per protocol
Who cannot join
- Illiteracy
- The Mini-Mental State Examination (MMSE) ≤ 23
- Medical history of mental illness such as schizophrenia, severe anxiety and depression.
- Medical history of Alzheimer's disease, Parkinson's disease, frontotemporal dementia or Huntington's disease.
- Dementia caused by other causes (such as central nervous system trauma, tumor, infection, metabolic disease, normal pressure hydrocephalus, folic acid, vitamin B12 deficiency, thyroid Inferior functions, etc.).
- History of epilepsy, or taking anti-epileptic drugs.
Show all 22Show fewer
- History of myocardial infarction or stroke
- History of malignant tumor
- Coagulation disorder, systemic bleeding; or previous coagulation disorder or systemic bleeding disease history.
- History of thrombocytopenia or neutropenia.
- History of blood system diseases or liver function abnormalities caused by medication
- Contraindications to ginkgo drugs and a history of known allergies.
- Aphasia, severe hearing or visual impairment, dominant hemiplegia, and other impacts on cognitive evaluation The status of the test.
- Known slow gait causes (non-neurological causes [such as: arthritis, heart disease] and neurological causes [bias Paralysis, ataxia, spasticity, Parkinson's disease and frontal lobe disease])
- Severe heart and lung diseases (coronary heart disease, LVEF<40%, NYHA heart failure grade ≥III, asthma asthma).
- Severe arrhythmia, heart rate >120bpm or <50bpm. (17) Blood pressure <90/60mmHg
- Severe anemia, Hb<100g/L
- Severe liver or renal insufficiency (ALT > 2 times the upper limit of normal or AST > 2 times the upper limit of normal; Creatinine >1.5 times the upper limit of normal)
- Leukopenia (<2×109/l) or thrombocytopenia (<100×109/l)
- Currently enrolled in other drug or medical device study
- Planned any surgery within 6 months at screening
- Considered by investigators as unsuitable participant of this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 10010
Jingjing Li, PhD, 13671197166, jingjingli0606@126.com
Jingjing Li, PhD
About this study
Official title: Evaluation of Efficacy and Safety of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome: A Multi-centre, Randomised, Double Blind and Placebo-controlled Study
This is a multi-centre, randomised, double blind, placebo controlled study on participants with Motoric Cognitive Risk Syndrome to evaluate the efficacy and safety of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution.
Read the detailed description
Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion.
Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that "motoric cognitive risk" (MCR) syndrome, which has been described in cognitively healthy individuals and combines subjective cognitive complaint with objective slow gait speed, is a pre-dementia syndrome.
MCR as a relatively new recognised clinical syndrome is with a high prevalence calculated around 10% in world population aged 60 and above. MCR syndrome predicts mild and major neurocognitive disorders. MCR syndrome does not rely on a complex and time-consuming assessment, making it applicable to the aging population. Thus, MCR syndrome seems to be a good syndrome to identify individuals at risk of mild and major neurocognitive disorders in any type of healthcare setting.
Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution has proven efficacy for cognitive function deterioration in preliminary studies. The aim of this study is to evaluate its efficacy and safety for MCR.
- Being tested
- Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution
- Keywords
- MCR, Ginkgo Leaf Extract, Armillariella Mellea Powder, MCI
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo Leaf Extract and Armillariella Mellea Powder Oral SolutionDrug
Also called Yinxingmihuan Koufuyongye
TID for 6 month after enrolment Glass oral bottle, 10 ml/bottle. Study Arm Component: Ginkgo Leaf Extract and Armillariella Mellea Powder, konjac (sweetener), purified water.
Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral SolutionDrug
Also called Yinxingmihuan Koufuyongye Moniji
TID for 6 month after enrolment Glass oral bottle, 10 ml/bottle. Placebo Arm Component: Caramel color (food color), konjac (sweetener), sucrose octaacetate (food additive), sodium benzoate (food additive), purified water.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID Receives: Drug: Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution |
| Control Arm | Placebo comparator | Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID Receives: Drug: Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ADAS-Cog
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) test is one of the most frequently used tests to measure cognition in research studies and clinical trials for new drugs and other interventions.The test administrator adds up points for the errors in each task of the ADAS-Cog for a total score ranging from 0 to 70. The greater the dysfunction, the greater the score. A score of 70 represents the most severe impairment and 0 represents the least impairment.
Measured: 6 month after enrolment
Secondary outcomes (11)
Frequency of Falls
Fall refers to sudden, involuntary, unintentional body position change, falling to the ground or lower plane. Falls include the following two types: (1) falls from one plane to another; (2) falls on the same plane.
Measured: 6 month after enrolment
Change of each items from ADAS-Cog
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): A score of 70 represents the most severe impairment and 0 represents the least impairment. The 12 items of ADAS-Cog applied in this study: Word Recall, Commands, Constructional Praxis, Naming, Ideational Praxis, Orientation, Word Recognition, Remembering Word Recognition Test Instructions, Comprehension of Spoken Language, Word-Finding Difficulty, Spoken Language Ability, Concentration/Distractibility
Measured: 6 month after enrolment
Percentage of change of ADAS-Cog score 4 or more
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): A score of 70 represents the most severe impairment and 0 represents the least impairment. Comparing to baseline, the percentage of ADAS-Cog score decreased 4 or more
Measured: 6 month after enrolment
TMT-A Score
Trail Making Test (TMT) Parts A \& B. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order.
Measured: 6 month after enrolment
TMT-B Score
Trail Making Test (TMT) Parts A \& B. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.).
Measured: 6 month after enrolment
Functional Activities Questionnaire score
Sum scores (range 0-30). Cutpoint of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment.
Measured: 6 month after enrolment
Activities of Daily Living (ADLs) score
ADL self-performance measures what the resident actually did (not what he or she might be capable of doing) within each ADL category over the prior seven days, according to a performance-based scale. ADL self-performance coding ranges from 0 (independent) to 4 (total dependence) and is coded as 20 items. The total ADL score is a very important component of the RUG categories and is calculated from the seven days immediately preceding and including the date of the assessment. Chang- es, including improvements and declines in function that have occurred since the assessment date are not considered when coding the MDS.
Measured: 6 month after enrolment
The Neuropsychiatric Inventory Questionnaire
The Neuropsychiatric Inventory-Questionnaire (NPI-Q) was developed and cross- validated with the standard NPI to provide a brief assessment of neuropsychiatric symptomatology in routine clinical practice settings. The NPI-Q is designed to be a self-administered questionnaire completed by informants about patients for whom they care. Each of the 12 NPI-Q domains contains a survey question that reflects cardinal symptoms of that domain.
Measured: 6 month after enrolment
Dementia Conversion Rate
Defined as conversion rate of MMSE≤23 at 6 month. The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia.
It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.
Measured: 6 month after enrolment
Single-task gait speed test
The test can be performed with any patient able to walk 4 metres using the instructions below:
- Instruct the patient to walk at their normal pace. Patients may use an assistive device, if needed.
- Ask the patient to walk down a hallway through a 1-metre zone for acceleration, a central 4- metre "testing" zone, and a 1-metre zone for deceleration (the patient should not start to slow down before the 4-metre mark).
- Start the timer with the first footfall after the 0-metre line.
- Stop the timer with the first footfall after the 4-metre line.
Measured: 6 month after enrolment
Dual-task gait speed test-naming animals
For the dual-task trials, participants walked the length of 4 metres while subtracting serial 7s from 100 aloud or while naming animals aloud.
Measured: 6 month after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start5 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motoric Cognitive Risk SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Stroke Association
- Responsible party
- Principal investigator, Jingjing Li, Beijing Tiantan Hospital
- Investigators
- Xingquan Zhao, PhD, Study chair, Department of Neurology, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492241
- Sponsor's protocol ID
- KY2020-052-03
- Status last verified
- Dec 2021
- First submitted
- 27 Jul 2020
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome: A Multi-centre, Randomised, Double Blind and Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04492241
- Acronym / sponsor ID
- KY2020-052-03
- Keywords
- MCR, Ginkgo Leaf Extract, Armillariella Mellea Powder, MCI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Stroke Association
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Jul 2020 (actual)
- 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.
This is a multi-centre, randomised, double blind, placebo controlled study on participants with Motoric Cognitive Risk Syndrome to evaluate the efficacy and safety of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution.
Detailed description
Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion.
Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that "motoric cognitive risk" (MCR) syndrome, which has been described in cognitively healthy individuals and combines subjective cognitive complaint with objective slow gait speed, is a pre-dementia syndrome.
MCR as a relatively new recognised clinical syndrome is with a high prevalence calculated around 10% in world population aged 60 and above. MCR syndrome predicts mild and major neurocognitive disorders. MCR syndrome does not rely on a complex and time-consuming assessment, making it applicable to the aging population. Thus, MCR syndrome seems to be a good syndrome to identify individuals at risk of mild and major neurocognitive disorders in any type of healthcare setting.
Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution has proven efficacy for cognitive function deterioration in preliminary studies. The aim of this study is to evaluate its efficacy and safety for MCR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Drug: Ginkgo Leaf Extract and Armillariella Mellea Powder Oral SolutionGinkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID |
| Control Arm | Placebo comparator | Drug: Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral SolutionSimulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign the informed consent form
- Capability of independent living (capability of dressing, bathing, walking, and bed-chair transfer)
- Met Motoric Cognitive Risk Syndrome (MCR) criteria:
- Single task slow gait ( male 60 to 74 y, gait <75.4 cm/s; male ≥ 75 y, gait < 59.1 cm/s; female 60 to 74 y, gait <70.0 cm/s; female ≥ 75 y, gait < 48.3 cm/s) And The Montreal Cognitive Assessment (MoCA) ≤ 26 (≥ 12 education year) or MoCA ≤ 25 (< 12 education year)
- Anticipated good compliance per protocol
Key exclusion criteria (22 listed)
- Illiteracy
- The Mini-Mental State Examination (MMSE) ≤ 23
- Medical history of mental illness such as schizophrenia, severe anxiety and depression.
- Medical history of Alzheimer's disease, Parkinson's disease, frontotemporal dementia or Huntington's disease.
- Dementia caused by other causes (such as central nervous system trauma, tumor, infection, metabolic disease, normal pressure hydrocephalus, folic acid, vitamin B12 deficiency, thyroid Inferior functions, etc.).
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 |
|---|---|---|
| Ginkgo Leaf Extract and Armillariella Mellea Powder Oral SolutionAlso: Yinxingmihuan KoufuyongyeTID for 6 month after enrolment Glass oral bottle, 10 ml/bottle. Study Arm Component: Ginkgo Leaf Extract and Armillariella Mellea Powder, konjac (sweetener), purified water. | Drug | Study Arm |
| Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral SolutionAlso: Yinxingmihuan Koufuyongye MonijiTID for 6 month after enrolment Glass oral bottle, 10 ml/bottle. Placebo Arm Component: Caramel color (food color), konjac (sweetener), sucrose octaacetate (food additive), sodium benzoate (food additive), purified water. | Drug | Control Arm |
Primary outcome
Change of ADAS-Cog
Time frame: 6 month after enrolment
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) test is one of the most frequently used tests to measure cognition in research studies and clinical trials for new drugs and other interventions.The test administrator adds up points for the errors in each task of the ADAS-Cog for a total score ranging from 0 to 70. The greater the dysfunction, the greater the score. A score of 70 represents the most severe impairment and 0 represents the least impairment.
11 secondary outcomes
Frequency of Falls
Time frame: 6 month after enrolment
Change of each items from ADAS-Cog
Time frame: 6 month after enrolment
Percentage of change of ADAS-Cog score 4 or more
Time frame: 6 month after enrolment
TMT-A Score
Time frame: 6 month after enrolment
TMT-B Score
Time frame: 6 month after enrolment
Functional Activities Questionnaire score
Time frame: 6 month after enrolment
Activities of Daily Living (ADLs) score
Time frame: 6 month after enrolment
The Neuropsychiatric Inventory Questionnaire
Time frame: 6 month after enrolment
Dementia Conversion Rate
Time frame: 6 month after enrolment
Single-task gait speed test
Time frame: 6 month after enrolment
Dual-task gait speed test-naming animals
Time frame: 6 month after enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
Related trials for Motoric Cognitive Risk Syndrome
Active, not recruitingObservational study
MCR Syndrome in Quebec : Results From NuAge Study
Motoric Cognitive Risk Syndrome, Aging Disorder
Recruiting
Motor-Cognitive Training for Motoric Cognitive Risk Syndrome
Motoric Cognitive Risk Syndrome
Recruiting
Effect of Exergaming Program Versus Neuromuscular Exercise in Elderly People With Motor Cognitive Risk Syndrome
Motoric Cognitive Risk Syndrome, Elderly (People Aged 65 or More)
Recruiting
Home-Based Brain Stimulation for Motoric Cognitive Risk Syndrome
Alzheimer Disease and Related Dementias, Cognition
Recruiting
Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome
Motoric Cognitive Risk Syndrome
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.
Xingquan Zhao, PhD study chair
Department of Neurology, Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution and Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution in people with Motoric Cognitive Risk Syndrome and Mild Cognitive Impairment, run by Beijing Tiantan Hospital at 1 site in China.
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 5 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingjing Li, PhD (+86 13671197166, jingjingli0606@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of ADAS-Cog (time frame: 6 month after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2021.