NCT07241897Not yet recruitingPhase 3
DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes
DPP4 Inhibitor on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes Mellitus (DISC-DM): Multicentre, Double Blind, Randomised, Placebo Controlled Trial
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
Post-stroke cognitive impairment (PSCI) increases the risk of disability and mortality in stroke patients, thereby exacerbating the disease burden of stroke. Type 2 diabetes is a major risk factor for PSCI, and stroke patients with type 2 diabetes have a higher risk of developing PSCI. Despite the high incidence and severe impact of PSCI, effective intervention methods are still lacking. Identifying safe and effective drugs to improve cognitive function in stroke patients and reduce the risk of PSCI, especially for those with type 2 diabetes, is of significant importance and could help reduce the burden of stroke. Dipeptidyl peptidase-4 (DPP4) inhibitors are first-line antidiabetic drugs, and several studies have shown that DPP4 inhibitors provide benefits beyond glucose control, including significantly improving cognitive function in patients with type 2 diabetes or slowing the progression of cognitive impairment. Our previous research found a significant negative correlation between baseline plasma soluble DPP4 (sDPP4) levels and the 90-day PSCI risk in ischemic stroke patients. Moreover, some studies indicate that DPP4 inhibitors can increase plasma sDPP4 levels. Based on this, we hypothesize that DPP4 inhibitors could be effective for PSCI intervention and may improve cognitive function post-stroke. This project aims to conduct a multicenter, randomized, double-blind, placebo-controlled study. We will include patients with mild ischemic stroke combined with type 2 diabetes and provide continuous intervention with DPP4 inhibitors or a placebo for 180 days. Cognitive function in both groups will be assessed before and after intervention to determine if DPP4 inhibitors can improve cognitive function and reduce the risk of PSCI in ischemic stroke patients with type 2 diabetes. Clinical blood samples and imaging data will also be used to preliminarily explore potential mechanisms.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 20 Sept 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Diseases
- Stroke, Type 2 diabetes
- NCT number
- NCT07241897
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 312
- From 15 Dec 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of cognitive-enhancing drugs, such as donepezil or memantine.
- Past or current use of DPP4 inhibitors.
- Past or current use of insulin therapy.
Other illness
- Coexisting dementia or severe cognitive impairment (MoCA \< 17).
- Allergy to DPP4 inhibitors.
- Type 1 diabetes, latent autoimmune diabetes in adults, secondary diabetes, malignant tumors, autoimmune diseases, or other endocrine-related diseases.
- Severe infection or severely impaired immune response.
Other
- Coexisting severe depression, defined as a Hamilton Depression Rating Scale (HAMD) score ≥ 20.
- Past or current use of GLP-1 agonists.
- Moderate or severe liver or kidney dysfunction.
- Chronic or acute pancreatitis.
- Pregnancy or lactation.
- Participation in other clinical trials.
Who the study is looking for
- Mild ischemic stroke, defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.
- Coexisting type 2 diabetes with a disease duration of less than 5 years.
- Ability to complete the MoCA, MMSE, and the NINDS-CSN-recommended 1-hour standardized neuropsychological test for VCI.
- Age between 40 and 75 years.
- Onset of stroke within the last 2 weeks.
- Glycated hemoglobin (HbA1c) between 6.5% and 8.5%.
- More than 9 years of education.
- Informed consent signed by the patient or their family.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.