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

Last updated: August 27, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Not Recruiting

Phase

4

Condition

Alzheimer's Disease

Mild Cognitive Impairment

Mental Disability

Treatment

Ginkgo biloba extract 50 dropping pills

Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant

Clinical Study ID

NCT06495476
KY2024-090-01
  • Ages 50-75
  • All Genders

Study 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

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 oneof the following requirements: Have ≥2 vascular risk factors (hypertension, hyperlipidemia, diabetes, currentsmoking); 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 domainabnormalities 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

Exclusion Criteria:

  1. Known or suspected allergy to the components of the investigational drug or allergicconstitution.

  2. With other brain diseases: Alzheimer's disease, Lewy body dementia, Parkinson'sdisease frontotemporal dementia, Crohn's disease, as well as other diseases that canlead to cognitive impairment, such as subdural hematoma, communicatinghydrocephalus, brain tumors, drug poisoning, alcoholism, thyroid disease, andvitamin deficiency.

  3. Previous diagnosis of genetic/degenerative/inflammatory related small cerebralvascular diseases, such as CADASIL, CARASIL, etc.

  4. Concomitant with major depressive disorder (≥24 score in HAMD-17) or other transientorganic psychosis (e.g., schizophrenia) that meets DSM-V criteria.

  5. Any medication used to treat cognitive impairment in the 4 weeks prior torandomization.

  6. Combined with severe neurological impairment, such as convenient hand hemiplegia,aphasia, auditory and visual impairment, the relevant examination or scaleevaluation can not be completed.

  7. Combined with severe gastrointestinal diseases such as indigestion, gastrointestinalobstruction, gastric and duodenal ulcers that can affect drug absorption, orinability to swallow medication.

  8. Liver enzymes (ALT, AST)>2 times the upper limit of normal value, creatinine>1.2times 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.

Study Design

Total Participants: 144
Treatment Group(s): 2
Primary Treatment: Ginkgo biloba extract 50 dropping pills
Phase: 4
Study Start date:
September 01, 2024
Estimated Completion Date:
June 30, 2026