Clinical trial NCT04492241: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Motoric Cognitive Risk Syndrome
Mild Cognitive Impairment
Aging
Locomotive Syndrome
Keywords: MCR
Ginkgo Leaf Extract
Armillariella Mellea Powder
MCI
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Stroke Association
First posted: 2020-07-30
Enrollment: 800
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of ADAS-Cog
timeFrame: 6 month after enrolment
Secondary outcomes:
measure: Frequency of Falls
timeFrame: 6 month after enrolment
measure: Change of each items from ADAS-Cog
timeFrame: 6 month after enrolment
measure: Percentage of change of ADAS-Cog score 4 or more
timeFrame: 6 month after enrolment
measure: TMT-A Score
timeFrame: 6 month after enrolment
measure: TMT-B Score
timeFrame: 6 month after enrolment
measure: Functional Activities Questionnaire score
timeFrame: 6 month after enrolment
measure: Activities of Daily Living (ADLs) score
timeFrame: 6 month after enrolment
measure: The Neuropsychiatric Inventory Questionnaire
timeFrame: 6 month after enrolment
measure: Dementia Conversion Rate
timeFrame: 6 month after enrolment
measure: Single-task gait speed test
timeFrame: 6 month after enrolment
measure: Dual-task gait speed test-naming animals
timeFrame: 6 month after enrolment
Other outcomes:
measure: Safety endpoints: major cerebral-cardiovascular events
timeFrame: 6 month after enrolment
measure: Adverse Drug Reaction
timeFrame: 6 month after enrolment
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Department of Neurology, Beijing Tiantan Hospital
name: Xingquan Zhao, PhD
role: STUDY_CHAIR
References: