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

NCT06495476 | Not Yet Recruiting Phase 4

• 1 other identifier: KY2024-090-01
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Montreal Cognitive Assessment Scale

  Montreal Cognitive Assessment Scale (Beijing Edition) scores from 0 to 30. A higher score indicates better cognitive function.

  At 12months±14days after randomization.

Secondary Outcomes (6)

• Change from baseline in Montreal Cognitive Assessment Scale

  At 3months±7days and 6months±14days after randomization.

• Changes from baseline in total cerebral small vessel disease burden

  At 12months±14days after randomization.

• Changes from baseline in Mini-mental State Examination score

  At 3months±7days, 6months±14days and 12months±14days after randomization.

• Change from baseline in the Ability Daily Living score

  At 3months±7days, 6months±14days and 12months±14days after randomization.

• Change from baseline in Social functioning questionnaire

  At 3months±7days, 6months±14days and 12months±14days after randomization.

Study Arms (2)

Ginkgo biloba extract 50 dropping pills treatment group

ACTIVE COMPARATOR

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

Drug: Ginkgo biloba extract 50 dropping pills

Ginkgo biloba extract 50 dropping pills Simulant treatment group

PLACEBO COMPARATOR

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

Drug: Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant

Interventions

Ginkgo biloba extract 50 dropping pills DRUG

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

Ginkgo biloba extract 50 dropping pills treatment group

Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant 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.

Ginkgo biloba extract 50 dropping pills Simulant treatment group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial is a double-blind design using simulants to ensure blinding. In order to ensure the unbiased clinical operation, observation, and evaluation of this trial, a centralized randomization system will be used to achieve the allocation of subject random numbers and therapeutic drugs. The simulants are consistent with the corresponding subject medications in terms of specifications, appearance, packaging, labeling, and marking, and are labeled for clinical trial use.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Beijing Tiantan Hospital

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: July 10, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08