Health TrialsbyHealthPanel

Clinical Study of GKT in Diabetes Related Dementia

ConditionDementia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60-90
SponsorShanghai 10th People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Type 1 diabetes;

Acute cerebral infarction and myocardial infarction within 3 months;

Severe liver and kidney dysfunction;

Late stage malignant tumors;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • placebo

    Drug

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

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: Ginkgo Ketone Ester Tablets Treatment GroupExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
six months

Secondary outcomes

1

Memory function assessment

Auditory Word Learning Test (AVLT-H),the lower the score, the more severe the cognitive impairment

Time frame
six months
2

Assessment of daily living ability

Functional Activity Questionnaire (FAQ)S,the higher the score, the more severe the cognitive impairment

Time frame
six months
3

Perform functional evaluation

Shape Connection Test A and B (STT-A\&B)，the higher the score, the more severe the cognitive impairment

Time frame
six months
4

Attention assessment

Symbolic Digital Form Test (SDMT)，the lower the score, the more severe the cognitive impairment

Time frame
six months

Other outcomes

1

Concentration of C-reactive protein

Human CRP(C-Reactive Protein) ELISA Kit for detecting C-reactive protein concentration (mg/L )in serum

Time frame
six months
2

Rate of arteriosclerosis in the large and middle arterial systems

ankle brachial pulse wave conduction velocity (m/s )detected by Arteriosclerosis tester

Time frame
six months
3

Rate of arterial blockage in limbs

ankle brachial blood pressure index (ABI) measures ankle blood pressure and upper arm brachial artery blood pressure through ankle brachial index instrument

Time frame
six months
4

Concentration of interleukin-6

interleukin-6(IL-6) in serum detected by interleukin-6 ELISA Kit

Time frame
six months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai 10th People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: