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

Beijing Tiantan Hospital800 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

800

Conditions

Motoric Cognitive Risk Syndrome Mild Cognitive Impairment Aging Locomotive Syndrome

Interventions

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral SolutionDRUG

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

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 6 month after enrolment

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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.

Central Contacts

Jingjing Li, PhD

CONTACT

+86 ‭13671197166‬jingjingli0606@126.com

Data from ClinicalTrials.gov

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