Effects of Henagliflozin on brain function in diabetes patients with mild cognitive impairment
A Prospective, Randomized, Open Label, Parallel, 6-month Study to Explore and Evaluate the Therapeutic Effects of Henagliflozin on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in T2DM Patients With Mild Cognitive Impairment.
NA · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT06085703
This study is testing if the diabetes medication Henagliflozin can help improve brain function in people with Type 2 Diabetes and mild cognitive impairment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06085703 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, randomized, open-label study designed to evaluate the effects of Henagliflozin on cognitive and olfactory functions in patients with Type 2 Diabetes Mellitus (T2DM) who also have mild cognitive impairment. The study will enroll 60 patients, randomly assigning them to receive either Henagliflozin or Gliclazide while continuing their existing metformin regimen. Assessments will include cognitive evaluations, olfactory tests, and functional MRI scans at baseline and after six months of treatment. The trial aims to determine if Henagliflozin can improve brain function in this patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55-75 with Type 2 Diabetes Mellitus and mild cognitive impairment who have been on a stable glucose-lowering regimen.
Not a fit: Patients with normal cognitive function, dementia, or other significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive function and quality of life for patients with T2DM and mild cognitive impairment.
How similar studies have performed: While there is ongoing research in this area, the specific effects of Henagliflozin on cognitive function in T2DM patients with mild cognitive impairment are novel and have not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with type 2 diabetes mellitus ; * Aged:55 -75 years ; * Cognitive function assessment suggests mild cognitive impairment; * A stable glucose-lowering regimen include Metformin alone or in combination with antidiabetic drugs other than SGLT2 inhibitors or sulfonylureas/glinides, or basic insulin for more than 2 months, and the dose of metformin≥1.0g/d; * HbA1c 7 - 10%; * ≥6 years of education; * Right-handed. Exclusion Criteria: * Cognitive function assessment suggests normal cognition or dementia; * Other dementia related neurological diseases or depression, Mental dysplasia, mania, schizophrenia, etc in the past 2 years; Central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction, etc; * Severe sinusitis, nasal cavity and sinus polyps, skull base or nasopharyngeal tumors and other space occupying lesions; * Congenital diseases and traumatic history of nose, maxillofacial and skull base affecting olfaction. * With symptoms of upper respiratory tract infection, including nasal congestion, runny nose, fever, etc. on the day of MR examination; * Diabetic Acute and chronic complications, including diabetic ketoacidosis, diabetic ketoacidosis; a hyperglycemic hyperosmolar state or severe hypoglycemic coma, etc. * Severe impairment of heart, liver, kidney and other organs; * Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, etc; * Pregnant and lactating women; * Receive other test drugs currently or within 3 months before participating in the project; * Known or suspected allergic history to the test drug or similar drugs; SGLT2 inhibitor and sulfonylureas/glinides were used in recent 3 months.
Where this trial is running
Nanjing, Jiangsu
- Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University — Nanjing, Jiangsu, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes Mellitus, Mild Cognitive Impairment, Functional MRI, Cognition, Olfactory function, Henagliflozin and Gliclazide