Clinical Study of GKT in Diabetes Related Dementia

Launched by SHANGHAI 10TH PEOPLE'S HOSPITAL · May 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new potential treatment for a type of dementia linked to diabetes, called diabetes-related dementia (DrD). Unlike other forms of dementia, DrD is considered manageable with the right approach. The researchers are testing Ginkgo biloba ketone ester tablets, which come from the Ginkgo biloba tree and may help improve blood flow to the brain, potentially benefiting memory and thinking skills. The goal is to see if these tablets can help people with DrD.

To participate in this study, you need to be at least 65 years old, have type 2 diabetes, and show early signs of memory problems. You must also be able to take pills and complete cognitive tests. However, if you've had certain serious health issues, like a recent stroke or severe liver or kidney problems, you won't be eligible. The study is not yet recruiting participants, but once it starts, those who join will be part of a carefully controlled trial, meaning neither they nor their doctors will know if they are receiving the Ginkgo tablets or a placebo (a non-active pill) during the study. This setup helps researchers accurately assess the effects of the treatment.

Gender

ALL

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.