Ischemic StrokePhase 3NCT07241897
DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes
A Phase 3 study testing Sentagliptin Phosphate - single dose in people with Ischemic Stroke and Diabete Mellitus, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Ischemic Stroke, Diabete Mellitus
- What is being tested?
- Sentagliptin Phosphate - single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 30 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Coexisting dementia or severe cognitive impairment (MoCA < 17).
- Coexisting severe depression, defined as a Hamilton Depression Rating Scale (HAMD) score ≥ 20.
- Prior use of cognitive-enhancing drugs, such as donepezil or memantine.
- Allergy to DPP4 inhibitors.
- Past or current use of DPP4 inhibitors.
- Past or current use of GLP-1 agonists.
Show all 13Show fewer
- Type 1 diabetes, latent autoimmune diabetes in adults, secondary diabetes, malignant tumors, autoimmune diseases, or other endocrine-related diseases.
- Moderate or severe liver or kidney dysfunction.
- Chronic or acute pancreatitis.
- Pregnancy or lactation.
- Severe infection or severely impaired immune response.
- Participation in other clinical trials.
- Past or current use of insulin therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Neurology, Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Shoujiang You, MD, PhD, 00 86 512 67783662, 0319503013@163.com
Yongjun Cao, MD, PhD, 00 86 512 67784789, yongjuncao@126.com
About this study
Official title: 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
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.
- Conditions
- Ischemic Stroke, Diabete Mellitus
- Being tested
- Sentagliptin Phosphate - single dose, Placebo
- Keywords
- DPP4 inhibitors, Ischemic Stroke, PSCI, Diabetes Mellitus, RCT
- Medical subject headings
- Ischemic Stroke, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentagliptin Phosphate - single doseDrug
Sentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed.
PlaceboDrug
Placebo (identical in size, shape, color, appearance, and odor to Sentagliptin Phosphate, 50 mg, once daily) plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Sentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. Receives: Drug: Sentagliptin Phosphate - single dose |
| Control Group | Placebo comparator | Placebo (identical in size, shape, color, appearance, and odor to Sentagliptin Phosphate, 50 mg, once daily) plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MoCA score before and after the 180-day intervention
Change in MoCA score before and after the 180-day intervention
Measured: 180 days
Secondary outcomes (4)
PSCI incidence at 180 days
MoCA score < 25
Measured: 180 days
Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention
Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention
Measured: 180 days
Changes in MoCA and MMSE scores before and after the 90-day intervention
Changes in MoCA and MMSE scores before and after the 90-day intervention
Measured: 90 days
Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days
Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days
Measured: 90 days and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: Sentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yifang zhu, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241897
- Sponsor's protocol ID
- LC2024019
- Other IDs
- 82471226
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
You S, Bi Y, Miao M, Bao A, Du J, Xu T, Liu CF, Zhang Y, He J, Cao Y, Zhong C. Plasma sDPP4 (Soluble Dipeptidyl Peptidase-4) and Cognitive Impairment After Noncardioembolic Acute Ischemic Stroke. Stroke. 2023 Jan;54(1):113-121. doi: 10.1161/STROKEAHA.122.040798. Epub 2022 Dec 7.
PubMed 36475470You S, Miao M, Lu Z, Bao A, Du J, Che B, Xu T, Zhong C, Cao Y, Liu CF, Zhang Y, He J. Plasma Soluble Dipeptidyl Peptidase-4 and Risk of Major Cardiovascular Events After Ischemic Stroke: Secondary Analysis of China Antihypertensive Trial in Acute Ischemic Stroke (CATIS). Neurology. 2022 Aug 30;99(9):e925-e934. doi: 10.1212/WNL.0000000000200784. Epub 2022 Jun 2.
PubMed 35654589Baggio LL, Varin EM, Koehler JA, Cao X, Lokhnygina Y, Stevens SR, Holman RR, Drucker DJ. Plasma levels of DPP4 activity and sDPP4 are dissociated from inflammation in mice and humans. Nat Commun. 2020 Jul 28;11(1):3766. doi: 10.1038/s41467-020-17556-z.
PubMed 32724076Ma M, Hasegawa Y, Koibuchi N, Toyama K, Uekawa K, Nakagawa T, Lin B, Kim-Mitsuyama S. DPP-4 inhibition with linagliptin ameliorates cognitive impairment and brain atrophy induced by transient cerebral ischemia in type 2 diabetic mice. Cardiovasc Diabetol. 2015 May 20;14:54. doi: 10.1186/s12933-015-0218-z.
PubMed 25986579Chiazza F, Tammen H, Pintana H, Lietzau G, Collino M, Nystrom T, Klein T, Darsalia V, Patrone C. The effect of DPP-4 inhibition to improve functional outcome after stroke is mediated by the SDF-1alpha/CXCR4 pathway. Cardiovasc Diabetol. 2018 May 19;17(1):60. doi: 10.1186/s12933-018-0702-3.
PubMed 29776406Borzi AM, Condorelli G, Biondi A, Basile F, Vicari ESD, Buscemi C, Luca S, Vacante M. Effects of vildagliptin, a DPP-4 inhibitor, in elderly diabetic patients with mild cognitive impairment. Arch Gerontol Geriatr. 2019 Sep-Oct;84:103896. doi: 10.1016/j.archger.2019.06.001. Epub 2019 Jun 3.
PubMed 31204117Jeong SH, Kim HR, Kim J, Kim H, Hong N, Jung JH, Baik K, Cho H, Lyoo CH, Ye BS, Sohn YH, Seong JK, Lee PH. Association of Dipeptidyl Peptidase-4 Inhibitor Use and Amyloid Burden in Patients With Diabetes and AD-Related Cognitive Impairment. Neurology. 2021 Sep 14;97(11):e1110-e1122. doi: 10.1212/WNL.0000000000012534. Epub 2021 Aug 11.
PubMed 34380754Sun C, Xiao Y, Li J, Ge B, Chen X, Liu H, Zheng T. Nonenzymatic function of DPP4 in diabetes-associated mitochondrial dysfunction and cognitive impairment. Alzheimers Dement. 2022 May;18(5):966-987. doi: 10.1002/alz.12437. Epub 2021 Aug 10.
PubMed 34374497Zhong J, Maiseyeu A, Davis SN, Rajagopalan S. DPP4 in cardiometabolic disease: recent insights from the laboratory and clinical trials of DPP4 inhibition. Circ Res. 2015 Apr 10;116(8):1491-504. doi: 10.1161/CIRCRESAHA.116.305665.
PubMed 25858071Mulvihill EE, Drucker DJ. Pharmacology, physiology, and mechanisms of action of dipeptidyl peptidase-4 inhibitors. Endocr Rev. 2014 Dec;35(6):992-1019. doi: 10.1210/er.2014-1035. Epub 2014 Sep 12.
PubMed 25216328Levine DA, Wadley VG, Langa KM, Unverzagt FW, Kabeto MU, Giordani B, Howard G, Howard VJ, Cushman M, Judd SE, Galecki AT. Risk Factors for Poststroke Cognitive Decline: The REGARDS Study (Reasons for Geographic and Racial Differences in Stroke). Stroke. 2018 Apr;49(4):987-994. doi: 10.1161/STROKEAHA.117.018529. Epub 2018 Mar 16.
PubMed 29581343Rost NS, Brodtmann A, Pase MP, van Veluw SJ, Biffi A, Duering M, Hinman JD, Dichgans M. Post-Stroke Cognitive Impairment and Dementia. Circ Res. 2022 Apr 15;130(8):1252-1271. doi: 10.1161/CIRCRESAHA.122.319951. Epub 2022 Apr 14.
PubMed 35420911
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07241897
- Acronym / sponsor ID
- LC2024019
- Conditions
- Ischemic Stroke, Diabete Mellitus
- Keywords
- DPP4 inhibitors, Ischemic Stroke, PSCI, Diabetes Mellitus, RCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Group: Sentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Sentagliptin Phosphate - single doseSentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. |
| Control Group | Placebo comparator | Drug: PlaceboPlacebo (identical in size, shape, color, appearance, and odor to Sentagliptin Phosphate, 50 mg, once daily) plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- Coexisting dementia or severe cognitive impairment (MoCA < 17).
- Coexisting severe depression, defined as a Hamilton Depression Rating Scale (HAMD) score ≥ 20.
- Prior use of cognitive-enhancing drugs, such as donepezil or memantine.
- Allergy to DPP4 inhibitors.
- Past or current use of DPP4 inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentagliptin Phosphate - single doseSentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. | Drug | Intervention Group |
| PlaceboPlacebo (identical in size, shape, color, appearance, and odor to Sentagliptin Phosphate, 50 mg, once daily) plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. | Drug | Control Group |
Primary outcome
Change in MoCA score before and after the 180-day intervention
Time frame: 180 days
Change in MoCA score before and after the 180-day intervention
4 secondary outcomes
PSCI incidence at 180 days
Time frame: 180 days
Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention
Time frame: 180 days
Changes in MoCA and MMSE scores before and after the 90-day intervention
Time frame: 90 days
Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days
Time frame: 90 days and 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 36475470You S, Bi Y, Miao M, Bao A, Du J, Xu T, Liu CF, Zhang Y, He J, Cao Y, Zhong C. Plasma sDPP4 (Soluble Dipeptidyl Peptidase-4) and Cognitive Impairment After Noncardioembolic Acute Ischemic Stroke. Stroke. 2023 Jan;54(1):113-121. doi: 10.1161/STROKEAHA.122.040798. Epub 2022 Dec 7.
- Results publication: PubMed 35654589You S, Miao M, Lu Z, Bao A, Du J, Che B, Xu T, Zhong C, Cao Y, Liu CF, Zhang Y, He J. Plasma Soluble Dipeptidyl Peptidase-4 and Risk of Major Cardiovascular Events After Ischemic Stroke: Secondary Analysis of China Antihypertensive Trial in Acute Ischemic Stroke (CATIS). Neurology. 2022 Aug 30;99(9):e925-e934. doi: 10.1212/WNL.0000000000200784. Epub 2022 Jun 2.
- Results publication: PubMed 32724076Baggio LL, Varin EM, Koehler JA, Cao X, Lokhnygina Y, Stevens SR, Holman RR, Drucker DJ. Plasma levels of DPP4 activity and sDPP4 are dissociated from inflammation in mice and humans. Nat Commun. 2020 Jul 28;11(1):3766. doi: 10.1038/s41467-020-17556-z.
- Results publication: PubMed 25986579Ma M, Hasegawa Y, Koibuchi N, Toyama K, Uekawa K, Nakagawa T, Lin B, Kim-Mitsuyama S. DPP-4 inhibition with linagliptin ameliorates cognitive impairment and brain atrophy induced by transient cerebral ischemia in type 2 diabetic mice. Cardiovasc Diabetol. 2015 May 20;14:54. doi: 10.1186/s12933-015-0218-z.
- Results publication: PubMed 29776406Chiazza F, Tammen H, Pintana H, Lietzau G, Collino M, Nystrom T, Klein T, Darsalia V, Patrone C. The effect of DPP-4 inhibition to improve functional outcome after stroke is mediated by the SDF-1alpha/CXCR4 pathway. Cardiovasc Diabetol. 2018 May 19;17(1):60. doi: 10.1186/s12933-018-0702-3.
- Results publication: PubMed 31204117Borzi AM, Condorelli G, Biondi A, Basile F, Vicari ESD, Buscemi C, Luca S, Vacante M. Effects of vildagliptin, a DPP-4 inhibitor, in elderly diabetic patients with mild cognitive impairment. Arch Gerontol Geriatr. 2019 Sep-Oct;84:103896. doi: 10.1016/j.archger.2019.06.001. Epub 2019 Jun 3.
- Results publication: PubMed 34380754Jeong SH, Kim HR, Kim J, Kim H, Hong N, Jung JH, Baik K, Cho H, Lyoo CH, Ye BS, Sohn YH, Seong JK, Lee PH. Association of Dipeptidyl Peptidase-4 Inhibitor Use and Amyloid Burden in Patients With Diabetes and AD-Related Cognitive Impairment. Neurology. 2021 Sep 14;97(11):e1110-e1122. doi: 10.1212/WNL.0000000000012534. Epub 2021 Aug 11.
- Results publication: PubMed 34374497Sun C, Xiao Y, Li J, Ge B, Chen X, Liu H, Zheng T. Nonenzymatic function of DPP4 in diabetes-associated mitochondrial dysfunction and cognitive impairment. Alzheimers Dement. 2022 May;18(5):966-987. doi: 10.1002/alz.12437. Epub 2021 Aug 10.
- Results publication: PubMed 25858071Zhong J, Maiseyeu A, Davis SN, Rajagopalan S. DPP4 in cardiometabolic disease: recent insights from the laboratory and clinical trials of DPP4 inhibition. Circ Res. 2015 Apr 10;116(8):1491-504. doi: 10.1161/CIRCRESAHA.116.305665.
- Results publication: PubMed 25216328Mulvihill EE, Drucker DJ. Pharmacology, physiology, and mechanisms of action of dipeptidyl peptidase-4 inhibitors. Endocr Rev. 2014 Dec;35(6):992-1019. doi: 10.1210/er.2014-1035. Epub 2014 Sep 12.
- Results publication: PubMed 29581343Levine DA, Wadley VG, Langa KM, Unverzagt FW, Kabeto MU, Giordani B, Howard G, Howard VJ, Cushman M, Judd SE, Galecki AT. Risk Factors for Poststroke Cognitive Decline: The REGARDS Study (Reasons for Geographic and Racial Differences in Stroke). Stroke. 2018 Apr;49(4):987-994. doi: 10.1161/STROKEAHA.117.018529. Epub 2018 Mar 16.
- Results publication: PubMed 35420911Rost NS, Brodtmann A, Pase MP, van Veluw SJ, Biffi A, Duering M, Hinman JD, Dichgans M. Post-Stroke Cognitive Impairment and Dementia. Circ Res. 2022 Apr 15;130(8):1252-1271. doi: 10.1161/CIRCRESAHA.122.319951. Epub 2022 Apr 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sentagliptin Phosphate - single dose in people with Ischemic Stroke and Diabete Mellitus, run by Second Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shoujiang You, MD, PhD (+8615995738506, 0319503013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MoCA score before and after the 180-day intervention (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07241897, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.