Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome
NCT ID: NCT04492241
Last Updated: 2021-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
800 participants
INTERVENTIONAL
2021-07-05
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Study Arm
Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID
Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution
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.
Control Arm
Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID
Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution
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.
Interventions
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Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution
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 Solution
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
85 Years
ALL
No
Sponsors
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Beijing Stroke Association
UNKNOWN
Beijing Tiantan Hospital
OTHER
Responsible Party
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Jingjing Li
Professor
Principal Investigators
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Xingquan Zhao, PhD
Role: STUDY_CHAIR
Department of Neurology, Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jingjing Li, PhD
Role: primary
Other Identifiers
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KY2020-052-03
Identifier Type: -
Identifier Source: org_study_id