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

NCT04492241 | Unknown

• 1 other identifier: KY2020-052-03
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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 Armillariella Mellea Powder Oral Solution.

Conditions

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

Keywords

MCR; Ginkgo Leaf Extract; Armillariella Mellea Powder; MCI

Outcome Measures

Primary Outcomes (1)

• Change of ADAS-Cog

  The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) test is one of the most frequently used tests to measure cognition in research studies and clinical trials for new drugs and other interventions.The test administrator adds up points for the errors in each task of the ADAS-Cog for a total score ranging from 0 to 70. The greater the dysfunction, the greater the score. A score of 70 represents the most severe impairment and 0 represents the least impairment.

  6 month after enrolment

Secondary Outcomes (11)

• Frequency of Falls

  6 month after enrolment

• Change of each items from ADAS-Cog

  6 month after enrolment

• Percentage of change of ADAS-Cog score 4 or more

  6 month after enrolment

• TMT-A Score

  6 month after enrolment

• TMT-B Score

  6 month after enrolment

Other Outcomes (2)

• Safety endpoints: major cerebral-cardiovascular events

  6 month after enrolment

• Adverse Drug Reaction

  6 month after enrolment

Study Arms (2)

Study Arm

EXPERIMENTAL

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID

Drug: Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution

Control Arm

PLACEBO COMPARATOR

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

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

Interventions

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution DRUG

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.

Also known as: Yinxingmihuan Koufuyongye

Study Arm

Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution DRUG

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.

Also known as: Yinxingmihuan Koufuyongye Moniji

Control Arm

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Stroke Association: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 10010, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xingquan Zhao, PhD

  Department of Neurology, Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Jingjing Li, PhD

CONTACT

+86 ‭13671197166‬; jingjingli0606@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: July 5, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: December 9, 2021

Record last verified: 2021-12

Locations

CN (1)