Clinical Study of GKT in Diabetes Related Dementia

NCT05855863 | Not Yet Recruiting Phase 4

• 1 other identifier: GKT
• Study Type: interventional
• Target: 370
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Cognitive function testing

  Alzheimer's Disease Assessment Scale-Cognitive section (0-70), the higher the score, the more severe the cognitive impairment

  six months

Secondary Outcomes (4)

• Memory function assessment

  six months

• Assessment of daily living ability

  six months

• Perform functional evaluation

  six months

• Attention assessment

  six months

Other Outcomes (10)

• Concentration of C-reactive protein

  six months

• Rate of arteriosclerosis in the large and middle arterial systems

  six months

• Rate of arterial blockage in limbs

  six months

Study Arms (2)

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

Drug: Ginkgo Ketone Ester Tablets

control group

PLACEBO COMPARATOR

placebo combined with conventional hypoglycemic therapy for 6 months

Drug: placebo

Interventions

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

Also known as: Test group

Ginkgo Ketone Ester Tablets Treatment Group

placebo DRUG

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

Also known as: Control group

control group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes with mild cognitive impairment patients aged 65 years or above;
• Able to cooperate in completing cognitive function testing;
• Patients who can swallow pills
• No previous history of stroke，cerebral thrombosis, etc

You may not qualify if:

• Type 1 diabetes;
• Acute cerebral infarction and myocardial infarction within 3 months;
• Severe liver and kidney dysfunction;
• Late stage malignant tumors;
• Thyroid dysfunction；
• Brain injury and cerebral hemorrhage within 3 months；
• Folic acid and/or vitamin B12 deficiency
• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Related Publications (6)

• 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.

  PMID: 23594859 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.

  PMID: 26289708 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.

  PMID: 25926349 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.

  PMID: 24405824 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.

  PMID: 26531676 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.

  PMID: 27109174 RESULT

MeSH Terms

Conditions

Dementia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 12, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share