Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical Trial

Prior treatment

• Receive other test drugs currently or within 3 months before participating in the project;

Other illness

• 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;
• 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;
• Severe impairment of heart, liver, kidney and other organs;
• Known or suspected allergic history to the test drug or similar drugs; SGLT2 inhibitor and sulfonylureas/glinides were used in recent 3 months.

Other

• Severe sinusitis, nasal cavity and sinus polyps, skull base or nasopharyngeal tumors and other space occupying lesions;
• Diabetic Acute and chronic complications, including diabetic ketoacidosis, diabetic ketoacidosis; a hyperglycemic hyperosmolar state or severe hypoglycemic coma, etc.
• Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, etc;
• Pregnant and lactating women;

• 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.