Clinical Study of GKT in Diabetes Related Dementia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This study was divided into two treatment groups: the experimental group and the control group. 364 patients were randomly selected and assigned to the experimental group of 182 patients and the control group of 182 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, 0.25g each time, and continuously administered for 6 months. Control group: placebo combined with conventional hypoglycemic treatment group. Neuropsychological testing of cognitive function was conducted using Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-cog), Color Trails Test (CTT), and Stroop Color Word Test (Stroop).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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ginkgo Ketone Ester Tablets Treatment Group Ginkgo Ketone Ester Tablets (Styron), taken orally, 3 times a day, 0.25g each time, continuously administered for 6 months |
Drug: Ginkgo Ketone Ester Tablets
Ginkgo Ketone Ester Tablets (Styron), taken orally, 3 times a day, 0.25g each time, continuously administered for 6 months
Other Names:
|
| Placebo Comparator: control group Placebo，taken orally, 3 times a day, 0.25g each time, continuously administered for 6 months |
Drug: Placebo
placebo，taken orally, 3 times a day, 0.25g each time, continuously administered for 6 months
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Perform functional evaluation [six months]
Color Trails Test (CTT) ,the higher the score, the more severe the cognitive impairment
- Behavioral control ability [six months]
Stroop Color Word Test (stroop),the lower the score, the more severe the cognitive impairment
Other Outcome Measures
- Concentration of C-reactive protein [six months]
Human CRP(C-Reactive Protein) ELISA Kit for detecting C-reactive protein concentration (mg/L )in serum
- Rate of arteriosclerosis in the large and middle arterial systems [six months]
ankle brachial pulse wave conduction velocity (m/s )detected by Arteriosclerosis tester
- Rate of arterial blockage in limbs [six months]
ankle brachial blood pressure index (ABI) measures ankle blood pressure and upper arm brachial artery blood pressure through ankle brachial index instrument
- Concentration of interleukin-6 [six months]
interleukin-6(IL-6) in serum detected by interleukin-6 ELISA Kit
- Concentration of phosphorylation (p) - tau217 [six months]
Plasma phosphorylation (p) - tau217detected by P-Tau217 detection kit
- Concentration of Amyloid protein Aβ 42/40 [six months]
Plasma Amyloid protein Aβ 42/40 detected by Aβ 42/40 detection kit
- Participants with ApoE4 genotype [six months]
ApoE4 genotype detected by ApoE4 genotype kit
- Concentration of antioxidant enzyme activity [six months]
Detection of glutathione peroxidase in serum
- Concentration of oxidative stress [six months]
Free radical detection in serum
- Concentration of irisin [six months]
Plasma irisin concentration detected by irisin ELISA kit
Eligibility Criteria
Criteria
Inclusion Criteria:
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Type 2 diabetes cognitive impairment patients aged 60 years or above;
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Able to cooperate in completing cognitive function testing;
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Patients who can swallow pills
Exclusion Criteria:
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Type 1 diabetes;
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Acute cerebral infarction and myocardial infarction within 3 months;
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Severe liver and kidney dysfunction;
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Late stage malignant tumors;
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Thyroid dysfunction；
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Brain injury and cerebral hemorrhage within 3 months；
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Folic acid and/or vitamin B12 deficiency
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai 10th People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GKT