Dementia
Conditions
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.
Interventions
DRUGGinkgo Ketone Ester Tablets
Ginkgo Ketone Ester Tablets taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months
DRUGplacebo
placebo, taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Memory function assessment | six months | Auditory Word Learning Test (AVLT-H),the lower 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 |
| Perform functional evaluation | six months | Shape Connection Test A and B (STT-A&B)，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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 C-reactive protein | six months | Human CRP(C-Reactive Protein) ELISA Kit for detecting C-reactive protein concentration (mg/L )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 |
| Concentration of antioxidant enzyme activity | six months | Detection of glutathione peroxidase 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 |
Outcome results
None listed