Clinical trial NCT06495476: Study on Ginkgo Biolba Extract Fifty and Mild Cognitive Impairment Associated With CSVD
Official title: Study on Ginkgo Biolba Extract Fifty in the Treatment of Mild Cognitive Impairment Associated With Cerebral Small Vessel Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Mild Cognitive Impairment
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 144
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial was a randomized, multicenter, double-blind, placebo-controlled parallel trial. Participants were randomly assigned according to the ratio of the experimental group: control group =1:1.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age 50-75 years old, with no limitation on sex.
2. 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);
3. 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.
4. Insufficient cognitive impairment to affect independence of life (mRS≤2).
5. After enrollment, you can live in the local stable for more than two years.
6. Sign the informed consent form.

Exclusion Criteria:

1. Known or suspected allergy to the components of the investigational drug or allergic constitution.
2. 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.
3. Previous diagnosis of genetic/degenerative/inflammatory related small cerebral vascular diseases, such as CADASIL, CARASIL, etc.
4. Concomitant with major depressive disorder (≥24 score in HAMD-17) or other transient organic psychosis (e.g., schizophrenia) that meets DSM-V criteria.
5. Any medication used to treat cognitive impairment in the 4 weeks prior to randomization.
6. 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.
7. Combined with severe gastrointestinal diseases such as indigestion, gastrointestinal obstruction, gastric and duodenal ulcers that can affect drug absorption, or inability to swallow medication.
8. 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).
9. Life expectancy \< 1 year, or other reasons for not being able to complete follow-up.
10. Pregnant or lactating women, or those with fertility plans.
11. Has participated in other clinical trials.

Primary outcomes:
measure: Change from baseline in Montreal Cognitive Assessment Scale
timeFrame: At 12months±14days after randomization.
Secondary outcomes:
measure: Change from baseline in Montreal Cognitive Assessment Scale
timeFrame: At 3months±7days and 6months±14days after randomization.
measure: Changes from baseline in total cerebral small vessel disease burden
timeFrame: At 12months±14days after randomization.
measure: Changes from baseline in Mini-mental State Examination score
timeFrame: At 3months±7days, 6months±14days and 12months±14days after randomization.
measure: Change from baseline in the Ability Daily Living score
timeFrame: At 3months±7days, 6months±14days and 12months±14days after randomization.
measure: Change from baseline in Social functioning questionnaire
timeFrame: At 3months±7days, 6months±14days and 12months±14days after randomization.
measure: Change from baseline in biomarkers
timeFrame: At 3months±7days, 6months±14days and 12months±14days after randomization.
Other outcomes:
Locations:
Study officials:
References: