Clinical Study of GKT in Diabetes Related Dementia

Phase 4

Not yet recruiting

• Conditions: Dementia
• Interventions: Drug: placebo; Drug: Ginkgo Ketone Ester Tablets

• Registration Number: NCT05855863
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

Recently a new clinical dementia subgroup based on brain imaging, called "diabetes related dementia (DrD)". DrD, unlike Alzheimer's disease and vascular dementia, is considered a "controllable" or "modifiable" form of dementia. However, there is currently a lack of corresponding treatment measures. Ginkgo biloba ketone ester tablets are extracts of Ginkgo biloba leaves. Previous studies have shown that they can increase cerebral blood flow, reduce cerebrovascular resistance, improve cerebral circulation, and are beneficial for the treatment of cognitive impairment. This project intends to explore the role of ginkgo ketoester tablets in diabetes related dementia through a multicenter randomized double-blind controlled clinical study.

Detailed Description

This study was divided into two treatment groups: the experimental group and the control group. 370 type 2 diabetes patients with mild cognitive impairmentpatients were randomly selected and assigned to the experimental group of 185 patients and the control group of 185 patients in a 1:1 equal amount. Experimental group: Ginkgo biloba ketone ester tablets combined with conventional hypoglycemic treatment group, the usage is Ginkgo biloba ketone ester tablets (Styron), taken orally, 3 times a day, 0.5g each time, and continuously administered for 6 months. Control group: conventional hypoglycemic treatment group. The Montreal Cognitive Assessment Basic (MoCA-B) was used for the detection of cognitive dysfunction. Neuropsychological testing of cognitive function was conducted using Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-cog), Auditory Word Learning Test (AVLT-H);Assessment of Daily Living Ability - Functional Activity Questionnaire (FAQ);Shape Connection Test A and B and Symbolic Digital Form Test (SDMT).Collect patients' blood, and detect C-reactive protein, interleukin-6, oxidative stress, ApoE4 genotype, phosphorylated tau protein, irisin, β- Amyloid protein before and after the experiment.Detect changes in ankle brachial pulse wave conduction velocity (baPWV)/and ankle brachial blood pressure index (ABI) of patients before and after the experiment.

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Study Start: 2023-12-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

1. Type 2 diabetes with mild cognitive impairment patients aged 65 years or above;
2. Able to cooperate in completing cognitive function testing;
3. Patients who can swallow pills
4. No previous history of stroke，cerebral thrombosis, etc

Exclusion Criteria

1. Type 1 diabetes;
2. Acute cerebral infarction and myocardial infarction within 3 months;
3. Severe liver and kidney dysfunction;
4. Late stage malignant tumors;
5. Thyroid dysfunction；
6. Brain injury and cerebral hemorrhage within 3 months；
7. Folic acid and/or vitamin B12 deficiency
8. Patients who are currently using thrombin inhibitors, defibrillators (with unclear efficacy in ischemic stroke and increased risk of bleeding), antiplatelet drugs, blood activating and stasis resolving agents, and other ginkgo biloba leaf preparations (as they may affect the evaluation of the therapeutic effect of ginkgo biloba ester tablets in this trial), as well as other trial medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	placebo	placebo combined with conventional hypoglycemic therapy for 6 months
Ginkgo Ketone Ester Tablets Treatment Group	Ginkgo Ketone Ester Tablets	Ginkgo Ketone Ester Tablets (Styron), taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic therapy continuously administered for 6 months

Primary Outcome Measures

Name	Time	Method
Cognitive function testing	six months	Alzheimer's Disease Assessment Scale-Cognitive section (0-70), the higher the score, the more severe the cognitive impairment

Secondary Outcome Measures

Name	Time	Method
Memory function assessment	six months	Auditory Word Learning Test (AVLT-H),the lower the score, the more severe the cognitive impairment
Perform functional evaluation	six months	Shape Connection Test A and B (STT-A\&B)，the higher the score, the more severe the cognitive impairment
Assessment of daily living ability	six months	Functional Activity Questionnaire (FAQ)S,the higher the score, the more severe the cognitive impairment
Attention assessment	six months	Symbolic Digital Form Test (SDMT)，the lower the score, the more severe the cognitive impairment