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

Capital Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Mild Cognitive Impairment

Treatments: Drug: Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant; Drug: Ginkgo biloba extract 50 dropping pills

Study type: Interventional

Funder types: Other

Identifiers

NCT06495476

KY2024-090-01

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

Ginkgo biloba extract 50 dropping pills treatment group

Active Comparator group

Description:

Ginkgo biloba extract 50 dropping pills, oral administration, 8 dropping pills /time, 3 times/day

Treatment:

Drug: Ginkgo biloba extract 50 dropping pills

Ginkgo biloba extract 50 dropping pills Simulant treatment group

Placebo Comparator group

Description:

Ginkgo biloba extract 50 dropping pills simulant, oral administration, 8 dropping pills /time, 3 times/day

Treatment:

Drug: Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant