MCIMCINCT07244770
The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients
An observational study of MCI, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The study aims to investigate the effects of DPP-4 Is+ metformin versus SGLT2 Is + metformin on the risk of cognitive decline and depression in patients with T2DM. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- MCI
- What is being tested?
- SGLT2 Is+METFORMIN and DPP4 Is+metformin
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Dec 2026
- Phase
- Observational
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: T2DM patients (aged above 55 years)
Who may be able to join
- -
- The study participants should meet the following inclusion criteria:
- T2DM adult subjects (>55 years old) will be eligible to participate.
- Patients should be taking SGLT2Is+metformin or DDP4Is + metformin for at least 1 year to be eligible.
Who cannot join
- 1- Those with type1 diabetes or ketoacidosis, insulin therapy, end organ failure as chronic renal failure, liver, and heart failure, previous history of pancreatitis, history of Alzheimer's disease or any brain insult, and finally pregnant or lactating females will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to investigate the effects of DPP-4 Is+ metformin versus SGLT2 Is + metformin on the risk of cognitive decline and depression in patients with T2DM.
Read the detailed description
Older people suffering from Type 2 Diabetes Mellitus possess a major risk for age related cognitive dysfunction and dementia, mainly due to vascular complications.
SGLT2 inhibitors and DPP4 inhibitors are antidiabetic medications, have shown promise not only in glycemic control but also in potentially mitigating cognitive decline and depressive symptoms.
- Conditions
- MCI
- Being tested
- SGLT2 Is+METFORMIN, DPP4 Is+metformin, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 Is+METFORMINDrug
Also called Group 1
Patients administering SGLT2 Is+metformin added to their treatment for at least the past 12 months
DPP4 Is+metforminDrug
Also called Group 2
Patients administering DPP4 I+ metformin added to their treatment for at least the past 12 months
Control groupDrug
Also called Group 3
patients administered their standard of care without any changes for the past 6 months
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 I Group | T2DM patients given SGLT2 Is + metformin added to standard of care Receives: Drug: SGLT2 Is+METFORMIN | |
| DPP4I group | T2DM patients given DPP4Is + metformin added to standard of care Receives: Drug: DPP4 Is+metformin | |
| Control group | T2DM patients given conventional therapy only Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCI
Changes in Montreal Cognitive Assessment (MoCA) score
Measured: Day 1
Depression
Changes in Patient Health Questionnaire-9 (PHQ-9) score
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jan 2025
- Primary completion1 Jul 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdelfattah Elsayed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244770
- Sponsor's protocol ID
- BeniSuef University Hospital
- Acronym
- MCI
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients
- ClinicalTrials.gov ID
- NCT07244770
- Acronym / sponsor ID
- MCI / BeniSuef University Hospital
- Conditions
- MCI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 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.
The study aims to investigate the effects of DPP-4 Is+ metformin versus SGLT2 Is + metformin on the risk of cognitive decline and depression in patients with T2DM.
Detailed description
Older people suffering from Type 2 Diabetes Mellitus possess a major risk for age related cognitive dysfunction and dementia, mainly due to vascular complications.
SGLT2 inhibitors and DPP4 inhibitors are antidiabetic medications, have shown promise not only in glycemic control but also in potentially mitigating cognitive decline and depressive symptoms.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SGLT2 I Group | – | Drug: SGLT2 Is+METFORMINT2DM patients given SGLT2 Is + metformin added to standard of care |
| DPP4I group | – | Drug: DPP4 Is+metforminT2DM patients given DPP4Is + metformin added to standard of care |
| Control group | – | Drug: Control groupT2DM patients given conventional therapy only |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- T2DM patients (aged above 55 years)
Key inclusion criteria (4 listed)
- -
- T2DM adult subjects (>55 years old) will be eligible to participate.
- Patients should be taking SGLT2Is+metformin or DDP4Is + metformin for at least 1 year to be eligible.
Key exclusion criteria (1 listed)
- 1- Those with type1 diabetes or ketoacidosis, insulin therapy, end organ failure as chronic renal failure, liver, and heart failure, previous history of pancreatitis, history of Alzheimer's disease or any brain insult, and finally pregnant or lactating females will be excluded from the study.
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 |
|---|---|---|
| SGLT2 Is+METFORMINAlso: Group 1Patients administering SGLT2 Is+metformin added to their treatment for at least the past 12 months | Drug | SGLT2 I Group |
| DPP4 Is+metforminAlso: Group 2Patients administering DPP4 I+ metformin added to their treatment for at least the past 12 months | Drug | DPP4I group |
| Control groupAlso: Group 3patients administered their standard of care without any changes for the past 6 months | Drug | Control group |
Primary outcome
MCI
Time frame: Day 1
Changes in Montreal Cognitive Assessment (MoCA) score
Depression
Time frame: Day 1
Changes in Patient Health Questionnaire-9 (PHQ-9) score
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 24 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MCI, run by Beni-Suef University at 1 site in Egypt.
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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCI (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.