Clinical trial NCT05855863: Clinical Study of GKT in Diabetes Related Dementia
Official title: Clinical Study of Ginkgo Biloba Ketone Ester Tablets in Diabetes Related Dementia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Dementia
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 370
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive function testing
timeFrame: six months
Secondary outcomes:
measure: Memory function assessment
timeFrame: six months
measure: Assessment of daily living ability
timeFrame: six months
measure: Perform functional evaluation
timeFrame: six months
measure: Attention assessment
timeFrame: six months
Other outcomes:
measure: Concentration of C-reactive protein
timeFrame: six months
measure: Rate of arteriosclerosis in the large and middle arterial systems
timeFrame: six months
measure: Rate of arterial blockage in limbs
timeFrame: six months
measure: Concentration of interleukin-6
timeFrame: six months
measure: Concentration of phosphorylation (p) - tau217
timeFrame: six months
measure: Concentration of Amyloid protein Aβ 42/40
timeFrame: six months
measure: Participants with ApoE4 genotype
timeFrame: six months
measure: Concentration of antioxidant enzyme activity
timeFrame: six months
measure: Concentration of oxidative stress
timeFrame: six months
measure: Concentration of irisin
timeFrame: six months
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.