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Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome

Primary Purpose

Motoric Cognitive Risk Syndrome, Mild Cognitive Impairment, Aging

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution

Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution

About this trial

This is an interventional treatment trial for Motoric Cognitive Risk Syndrome focused on measuring MCR, Ginkgo Leaf Extract, Armillariella Mellea Powder, MCI

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
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

Sites / Locations

Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Arm

Control Arm

Arm Description

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID

Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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

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.

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.).

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04492241

First Posted

July 27, 2020

Last Updated

December 7, 2021

Sponsor

Beijing Tiantan Hospital

Collaborators

Beijing Stroke Association

1. Study Identification

Unique Protocol Identification Number

NCT04492241

Brief Title

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 5, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tiantan Hospital

Collaborators

Beijing Stroke Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Motoric Cognitive Risk Syndrome, Mild Cognitive Impairment, Aging, Locomotive Syndrome

Keywords

MCR, Ginkgo Leaf Extract, Armillariella Mellea Powder, MCI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Arm

Arm Type

Experimental

Arm Description

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID

Arm Title

Control Arm

Arm Type

Placebo Comparator

Arm Description

Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID

Intervention Type

Drug

Intervention Name(s)

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution

Other Intervention Name(s)

Yinxingmihuan Koufuyongye

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution

Other Intervention Name(s)

Yinxingmihuan Koufuyongye Moniji

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of ADAS-Cog

Description

Time Frame

6 month after enrolment

Secondary Outcome Measure Information:

Title

Frequency of Falls

Description

Time Frame

6 month after enrolment

Title

Change of each items from ADAS-Cog

Description

Time Frame

6 month after enrolment

Title

Percentage of change of ADAS-Cog score 4 or more

Description

Time Frame

6 month after enrolment

Title

TMT-A Score

Description

Time Frame

6 month after enrolment

Title

TMT-B Score

Description

Time Frame

6 month after enrolment

Title

Functional Activities Questionnaire score

Description

Sum scores (range 0-30). Cutpoint of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment.

Time Frame

6 month after enrolment

Title

Activities of Daily Living (ADLs) score

Description

Time Frame

6 month after enrolment

Title

The Neuropsychiatric Inventory Questionnaire

Description

Time Frame

6 month after enrolment

Title

Dementia Conversion Rate

Description

Time Frame

6 month after enrolment

Title

Single-task gait speed test

Description

Time Frame

6 month after enrolment

Title

Dual-task gait speed test-naming animals

Description

For the dual-task trials, participants walked the length of 4 metres while subtracting serial 7s from 100 aloud or while naming animals aloud.

Time Frame

6 month after enrolment

Other Pre-specified Outcome Measures:

Title

Safety endpoints: major cerebral-cardiovascular events

Description

Defined as any non-fatal acute myocardial infarction, non-fatal stroke, cardiovascular death.

Time Frame

6 month after enrolment

Title

Adverse Drug Reaction

Description

An adverse drug reaction is a harmful reaction to a medicine given at the correct dose.

Time Frame

6 month after enrolment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jingjing Li, PhD

Phone

+86 ‭13671197166‬

jingjingli0606@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xingquan Zhao, PhD

Organizational Affiliation

Department of Neurology, Beijing Tiantan Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing Tiantan Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

10010

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jingjing Li, PhD

Phone

13671197166‬

jingjingli0606@126.com

First Name & Middle Initial & Last Name & Degree

Jingjing Li, PhD

First Name & Middle Initial & Last Name & Degree

Xingquan Zhao, PhD

12. IPD Sharing Statement

Learn more about this trial

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome

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