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

Capital Medical University

Status: Enrolling

Conditions: Aging; Locomotive Syndrome; Mild Cognitive Impairment; Motoric Cognitive Risk Syndrome

Treatments: Drug: Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution; Drug: Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04492241

KY2020-052-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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800 participants in 2 patient groups, including a placebo group

Study Arm

Experimental group

Description:

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID

Treatment:

Drug: Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution

Control Arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution