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

NCT ID: NCT06495476

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-06-30

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ginkgo biloba extract 50 dropping pills treatment group

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

Group Type: ACTIVE_COMPARATOR

Ginkgo biloba extract 50 dropping pills

Intervention Type: DRUG

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

Ginkgo biloba extract 50 dropping pills Simulant treatment group

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

Group Type: PLACEBO_COMPARATOR

Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant

Intervention Type: 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.

Interventions

Ginkgo biloba extract 50 dropping pills

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

yilong Wang

Vice President of Beijing Tiantan Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KY2024-090-01

Identifier Type: -

Identifier Source: org_study_id