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

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborator: Beijing Stroke Association
• Treatments: Pharmaceutical Solutions

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