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NCT Number: NCT06495476

Study on Ginkgo Biolba Extract Fifty and Mild Cognitive Impairment Associated With CSVD

This study aimed to explore the efficacy and safety of Ginkgo Biolba Extract fifty in treating mild cognitive impairment associated with cerebral small vessel disease (CSVD). Subjects included based on eligibility criteria were randomized into treatment and control groups. Patients will receive the drug or placebo for 12 months. Patients were followed at baseline and at 3 months, 6 months, and 12 months after randomization. The primary outcome was the difference from baseline in the Montreal Cognitive Assessmen (MoCA) score at 12 months after randomization.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50-75 years old, with no limitation on sex.
  • Head MRI showed SVD lesions. High white matter signal, Fazekas score ≥2 and meet one of the following requirements:

Have ≥2 vascular risk factors (hypertension, hyperlipidemia, diabetes, current smoking); Combined lacunar foci; Combined with a new subcortical lacunar infarction (within 7 days of onset);

  • Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a score of 18 ≤MoCA score < 26.
  • Insufficient cognitive impairment to affect independence of life (mRS≤2).
  • After enrollment, you can live in the local stable for more than two years.
  • Sign the informed consent form.

Exclusion criteria

  • Known or suspected allergy to the components of the investigational drug or allergic constitution.
  • With other brain diseases: Alzheimer's disease, Lewy body dementia, Parkinson's disease frontotemporal dementia, Crohn's disease, as well as other diseases that can lead to cognitive impairment, such as subdural hematoma, communicating hydrocephalus, brain tumors, drug poisoning, alcoholism, thyroid disease, and vitamin deficiency.
  • Previous diagnosis of genetic/degenerative/inflammatory related small cerebral vascular diseases, such as CADASIL, CARASIL, etc.
  • Concomitant with major depressive disorder (≥24 score in HAMD-17) or other transient organic psychosis (e.g., schizophrenia) that meets DSM-V criteria.
  • Any medication used to treat cognitive impairment in the 4 weeks prior to randomization.
  • Combined with severe neurological impairment, such as convenient hand hemiplegia, aphasia, auditory and visual impairment, the relevant examination or scale evaluation can not be completed.
  • Combined with severe gastrointestinal diseases such as indigestion, gastrointestinal obstruction, gastric and duodenal ulcers that can affect drug absorption, or inability to swallow medication.
  • Liver enzymes (ALT, AST)>2 times the upper limit of normal value, creatinine>1.2 times the upper limit of normal value, and decreased glomerular filtration rate (<90ml/min).
  • Life expectancy < 1 year, or other reasons for not being able to complete follow-up.
  • Pregnant or lactating women, or those with fertility plans.
  • Has participated in other clinical trials.

Treatment and study plan

Ginkgo biloba extract 50 dropping pills

Drug

Composition: Ginkgo ketone ester, excipient polyethylene glycol 6000. Size: 10mg ginkgolides/pill.

Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant

Drug

Composition: The main ingredient is polyethylene glycol 6000 + caramel pigment, placebo and ginkgolide drops are basically the same in color, odor and appearance.

Size: 10 mg analog ingredient/pill.

Primary outcomes

  1. Change from baseline in Montreal Cognitive Assessment Scale

    Time frame: At 12months±14days after randomization.

    Montreal Cognitive Assessment Scale (Beijing Edition) scores from 0 to 30. A higher score indicates better cognitive function.

Secondary outcomes

  1. Change from baseline in Montreal Cognitive Assessment Scale

    Time frame: At 3months±7days and 6months±14days after randomization.

    Montreal Cognitive Assessment Scale (Beijing Edition) scores from 0 to 30. Higher score indicates better cognitive function.

  2. Changes from baseline in total cerebral small vessel disease burden

    Time frame: At 12months±14days after randomization.

    The severity of periventricular WMH (PV-WMH) and the deep-WMH were rated by Fazekas rating scale. The numbers of lacune and cerebral microbleed (CMB) will be collected. Perivascular spaces (PVS) in the basal ganglia was rated with the semi-quantitative rating scale developed by the Edinburg group. Total CSVD burden was the sum of points awarded for the presence or absence of four MRI markers: one point was awarded if lacunes were present, one point was awarded if CMBs were present, one point was awarded if there were moderate to severe PVS (>10) in the basal ganglia, and one point was awarded for either confluent deep WMH (Fazekas scale 2 or 3) or irregular PV-WMH extending into the deep white matter (Fazekas score 3).

  3. Changes from baseline in Mini-mental State Examination score

    Time frame: At 3months±7days, 6months±14days and 12months±14days after randomization.

    Mini-mental State Examination (MMSE) scores from 0 to 30. A higher score indicates better cognitive function.

  4. Change from baseline in the Ability Daily Living score

    Time frame: At 3months±7days, 6months±14days and 12months±14days after randomization.

    Ability Daily Living (ADL) scores from 14 to 56. A higher score indicates a worse ability of daily living.

  5. Change from baseline in Social functioning questionnaire

    Time frame: At 3months±7days, 6months±14days and 12months±14days after randomization.

    Social functioning questionnaire (FAQ) scores from 0 to 30. A higher score indicates a worse capacity of action.

  6. Change from baseline in biomarkers

    Time frame: At 3months±7days, 6months±14days and 12months±14days after randomization.

    Biomarkers including hs-CRP, IL-6, TNF-α, Hcy, D-dimer, Fib

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Study on Ginkgo Biolba Extract Fifty in the Treatment of Mild Cognitive Impairment Associated With Cerebral Small Vessel Disease

Acronym: GRACE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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