Status:
UNKNOWN
Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Beijing Stroke Association
Conditions:
Motoric Cognitive Risk Syndrome
Mild Cognitive Impairment
Eligibility:
All Genders
60-85 years
Phase:
NA
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 Armillari...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04492241
Start Date
July 5 2021
End Date
December 31 2024
Last Update
December 9 2021
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 10010