Last updated: December 7, 2021
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Dementia
Alzheimer's Disease
Mild Cognitive Impairment
Treatment
N/AClinical Study ID
NCT04492241
KY2020-052-03
Ages 60-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Sign the informed consent form
- Capability of independent living (capability of dressing, bathing, walking, andbed-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 MontrealCognitive Assessment (MoCA) ≤ 26 (≥ 12 education year) or MoCA ≤ 25 (< 12 education year)
- Anticipated good compliance per protocol
Exclusion
Exclusion Criteria:
- Illiteracy
- The Mini-Mental State Examination (MMSE) ≤ 23
- Medical history of mental illness such as schizophrenia, severe anxiety anddepression.
- Medical history of Alzheimer's disease, Parkinson's disease, frontotemporal dementiaor Huntington's disease.
- Dementia caused by other causes (such as central nervous system trauma, tumor,infection, metabolic disease, normal pressure hydrocephalus, folic acid, vitamin B12deficiency, 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 systemicbleeding 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 impactson 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 andfrontal lobe disease])
- Severe heart and lung diseases (coronary heart disease, LVEF<40%, NYHA heart failuregrade ≥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
Study Design
Total Participants: 800
Study Start date:
July 05, 2021
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Beijing Tiantan Hospital
Beijing, Beijing 10010
ChinaActive - Recruiting
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