Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT06085703
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT06085703
Study Brief:
Protocol Section:
NCT06085703