Clinical Study of GKT in Diabetes Related Dementia

Study Overview
=================
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.

Official Title
-----------------
Clinical Study of Ginkgo Biloba Ketone Ester Tablets in Diabetes Related Dementia

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Drug: Ginkgo Ketone Ester Tablets
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes with mild cognitive impairment patients aged 65 years or above; Able to cooperate in completing cognitive function testing; Patients who can swallow pills No previous history of stroke，cerebral thrombosis, etc Exclusion Criteria: Type 1 diabetes; Acute cerebral infarction and myocardial infarction within 3 months; Severe liver and kidney dysfunction; Late stage malignant tumors; Thyroid dysfunction； Brain injury and cerebral hemorrhage within 3 months； Folic acid and/or vitamin B12 deficiency 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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginkgo Ketone Ester Tablets Treatment Group<br>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 | Drug: Ginkgo Ketone Ester Tablets<br>* Ginkgo Ketone Ester Tablets taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months<br>* Other names: Test group;|
| Placebo Comparator: control group<br>placebo combined with conventional hypoglycemic therapy for 6 months | Drug: placebo<br>* placebo, taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months<br>* Other names: Control group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function testing | Alzheimer's Disease Assessment Scale-Cognitive section (0-70), the higher the score, the more severe the cognitive impairment | six months | 

Secondary Outcome Measures

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