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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Ginkgo biloba extract 50 dropping pills
  Composition: Ginkgo ketone ester, excipient polyethylene glycol 6000. Size: 10mg ginkgolides/pill.
• Препарат Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant
  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.

Первичные конечные точки

• Change from baseline in Montreal Cognitive Assessment Scale [Срок оценки: At 12months±14days after randomization.]

Вторичные конечные точки (6)

• Change from baseline in Montreal Cognitive Assessment Scale [Срок оценки: At 3months±7days and 6months±14days after randomization.]
• Changes from baseline in total cerebral small vessel disease burden [Срок оценки: At 12months±14days after randomization.]
• Changes from baseline in Mini-mental State Examination score [Срок оценки: At 3months±7days, 6months±14days and 12months±14days after randomization.]
• Change from baseline in the Ability Daily Living score [Срок оценки: At 3months±7days, 6months±14days and 12months±14days after randomization.]
• Change from baseline in Social functioning questionnaire [Срок оценки: At 3months±7days, 6months±14days and 12months±14days after randomization.]
• Change from baseline in biomarkers [Срок оценки: At 3months±7days, 6months±14days and 12months±14days after randomization.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06495476 · KY2024-090-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗