Clinical Study of GKT in Diabetes Related Dementia

NCT ID: NCT05855863

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-06-30

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ginkgo Ketone Ester Tablets Treatment Group

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

Group Type: EXPERIMENTAL

Ginkgo Ketone Ester Tablets

Intervention Type: DRUG

Ginkgo Ketone Ester Tablets taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months

control group

placebo combined with conventional hypoglycemic therapy for 6 months

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo, taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months

Interventions

Ginkgo 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

Intervention Type: DRUG

placebo

placebo, taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months

Intervention Type: DRUG

Other Intervention Names

Test group; Control group

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guoxiang Fu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 23594859 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26289708 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25926349 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24405824 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26531676 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27109174 (View on PubMed)

Other Identifiers

GKT

Identifier Type: -

Identifier Source: org_study_id