Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04492241
Other study ID # KY2020-052-03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 5, 2021
Est. completion date December 31, 2024

Study information

Verified date December 2021
Source Beijing Tiantan Hospital
Contact Jingjing Li, PhD
Phone +86 ?13671197166?
Email jingjingli0606@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years to 85 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
China Beijing Tiantan Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Beijing Tiantan Hospital Beijing Stroke Association

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety endpoints: major cerebral-cardiovascular events Defined as any non-fatal acute myocardial infarction, non-fatal stroke, cardiovascular death. 6 month after enrolment
Other Adverse Drug Reaction An adverse drug reaction is a harmful reaction to a medicine given at the correct dose. 6 month after enrolment
Primary 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 Frequency of Falls Fall refers to sudden, involuntary, unintentional body position change, falling to the ground or lower plane. Falls include the following two types: (1) falls from one plane to another; (2) falls on the same plane. 6 month after enrolment
Secondary Change of each items from ADAS-Cog The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): A score of 70 represents the most severe impairment and 0 represents the least impairment. The 12 items of ADAS-Cog applied in this study: Word Recall, Commands, Constructional Praxis, Naming, Ideational Praxis, Orientation, Word Recognition, Remembering Word Recognition Test Instructions, Comprehension of Spoken Language, Word-Finding Difficulty, Spoken Language Ability, Concentration/Distractibility 6 month after enrolment
Secondary Percentage of change of ADAS-Cog score 4 or more The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): A score of 70 represents the most severe impairment and 0 represents the least impairment. Comparing to baseline, the percentage of ADAS-Cog score decreased 4 or more 6 month after enrolment
Secondary TMT-A Score Trail Making Test (TMT) Parts A & B. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. 6 month after enrolment
Secondary TMT-B Score Trail Making Test (TMT) Parts A & B. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). 6 month after enrolment
Secondary Functional Activities Questionnaire score Sum scores (range 0-30). Cutpoint of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. 6 month after enrolment
Secondary Activities of Daily Living (ADLs) score ADL self-performance measures what the resident actually did (not what he or she might be capable of doing) within each ADL category over the prior seven days, according to a performance-based scale. ADL self-performance coding ranges from 0 (independent) to 4 (total dependence) and is coded as 20 items. The total ADL score is a very important component of the RUG categories and is calculated from the seven days immediately preceding and including the date of the assessment. Chang- es, including improvements and declines in function that have occurred since the assessment date are not considered when coding the MDS. 6 month after enrolment
Secondary The Neuropsychiatric Inventory Questionnaire The Neuropsychiatric Inventory-Questionnaire (NPI-Q) was developed and cross- validated with the standard NPI to provide a brief assessment of neuropsychiatric symptomatology in routine clinical practice settings. The NPI-Q is designed to be a self-administered questionnaire completed by informants about patients for whom they care. Each of the 12 NPI-Q domains contains a survey question that reflects cardinal symptoms of that domain. 6 month after enrolment
Secondary Dementia Conversion Rate Defined as conversion rate of MMSE=23 at 6 month. The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia.
It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.
6 month after enrolment
Secondary Single-task gait speed test The test can be performed with any patient able to walk 4 metres using the instructions below:
Instruct the patient to walk at their normal pace. Patients may use an assistive device, if needed.
Ask the patient to walk down a hallway through a 1-metre zone for acceleration, a central 4- metre "testing" zone, and a 1-metre zone for deceleration (the patient should not start to slow down before the 4-metre mark).
Start the timer with the first footfall after the 0-metre line.
Stop the timer with the first footfall after the 4-metre line.
6 month after enrolment
Secondary Dual-task gait speed test-naming animals For the dual-task trials, participants walked the length of 4 metres while subtracting serial 7s from 100 aloud or while naming animals aloud. 6 month after enrolment
See also
  Status Clinical Trial Phase
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT05293730 - Trial of the Impact of the Electronic Frailty Integrated With Social Needs N/A
Recruiting NCT03932162 - Gene Expression Changes In Young and Geriatric Skin Early Phase 1
Completed NCT04064528 - Effects of Age on Amino Acid Delivery to Tendon N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Recruiting NCT05566938 - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly N/A
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Enrolling by invitation NCT04641663 - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST) N/A
Completed NCT04088006 - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05424263 - Acetate and Age-associated Arterial Dysfunction Phase 2
Completed NCT05601713 - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling N/A
Completed NCT04551339 - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 N/A
Recruiting NCT04997577 - Speech Perception and High Cognitive Demand N/A
Completed NCT05922475 - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A