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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginkgo Ketone Ester Tablets Treatment Group | Experimental | 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 |
|
| control group | Placebo Comparator | placebo combined with conventional hypoglycemic therapy for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginkgo Ketone Ester Tablets | Drug | Ginkgo Ketone Ester Tablets taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of C-reactive protein | Human CRP(C-Reactive Protein) ELISA Kit for detecting C-reactive protein concentration (mg/L )in serum | six months |
| Rate of arteriosclerosis in the large and middle arterial systems |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23594859 | Result | Fukazawa R, Hanyu H, Sato T, Shimizu S, Koyama S, Kanetaka H, Sakurai H, Iwamoto T. Subgroups of Alzheimer's disease associated with diabetes mellitus based on brain imaging. Dement Geriatr Cogn Disord. 2013;35(5-6):280-90. doi: 10.1159/000348407. Epub 2013 Apr 13. | |
| 26289708 | Result | Hanyu H, Hirose D, Fukasawa R, Hatanaka H, Namioka N, Sakurai H. Guidelines for the Clinical Diagnosis of Diabetes Mellitus-Related Dementia. J Am Geriatr Soc. 2015 Aug;63(8):1721-3. doi: 10.1111/jgs.13581. No abstract available. |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| placebo | Drug | placebo, taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months |
|
|
| 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 |
ankle brachial pulse wave conduction velocity (m/s )detected by Arteriosclerosis tester
| six months |
| Rate of arterial blockage in limbs | ankle brachial blood pressure index (ABI) measures ankle blood pressure and upper arm brachial artery blood pressure through ankle brachial index instrument | six months |
| Concentration of interleukin-6 | interleukin-6(IL-6) in serum detected by interleukin-6 ELISA Kit | six months |
| Concentration of phosphorylation (p) - tau217 | Plasma phosphorylation (p) - tau217detected by P-Tau217 detection kit | six months |
| Concentration of Amyloid protein Aβ 42/40 | Plasma Amyloid protein Aβ 42/40 detected by Aβ 42/40 detection kit | six months |
| Participants with ApoE4 genotype | ApoE4 genotype detected by ApoE4 genotype kit | six months |
| Concentration of antioxidant enzyme activity | Detection of glutathione peroxidase in serum | six months |
| Concentration of oxidative stress | Free radical detection in serum | six months |
| Concentration of irisin | Plasma irisin concentration detected by irisin ELISA kit | six months |
| 25926349 | Result | Verdile G, Fuller SJ, Martins RN. The role of type 2 diabetes in neurodegeneration. Neurobiol Dis. 2015 Dec;84:22-38. doi: 10.1016/j.nbd.2015.04.008. Epub 2015 Apr 26. |
| 24405824 | Result | Fukasawa R, Hanyu H, Namioka N, Hatanaka H, Sato T, Sakurai H. Elevated inflammatory markers in diabetes-related dementia. Geriatr Gerontol Int. 2014 Jan;14(1):229-31. doi: 10.1111/ggi.12140. No abstract available. |
| 26531676 | Result | Hatanaka H, Hanyu H, Fukasawa R, Sato T, Shimizu S, Sakurai H. Peripheral oxidative stress markers in diabetes-related dementia. Geriatr Gerontol Int. 2016 Dec;16(12):1312-1318. doi: 10.1111/ggi.12645. Epub 2015 Nov 4. |
| 27109174 | Result | Hirose D, Hanyu H, Fukasawa R, Hatanaka H, Namioka N, Sakurai H. Frailty in diabetes-related dementia. Geriatr Gerontol Int. 2016 May;16(5):653-5. doi: 10.1111/ggi.12566. No abstract available. |
| D001523 | Mental Disorders |
| D008722 | Methods |