Mild Cognitive Impairment
Conditions
Interventions
Dapagliflozin:Dapagliflozin
Placebo:Placebo
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosed with type 2 diabetes for at least 1 year according to the 2024 CDS clinical practice guidelines 2. Aged >= 65 years 3. Male or Female 4. Clinically diagnosed with mild cognitive impairment, with a Montreal Cognitive Assessment-Basic (MoCA-B) score of 18–26, and no significant impairment in activities of daily living attributable to cognitive decline 5. Treated with metformin alone or in combination with one non-SGLT2 inhibitor antihyperglycemic agent (e.g., sulfonylureas, glinides) 6. Life expectancy >= 3 years 7. No severe hearing, visual, or communication impairments, and able to complete cognitive assessments, laboratory tests, and scheduled follow-up visits
Exclusion criteria
Exclusion criteria: 1. Normal cognitive function or dementia indicated by cognitive assessment. 2. Other neurological disorders associated with dementia, or a history of depression within the past 2 years; mental developmental abnormalities, mania, depression, schizophrenia, etc. 3. Central nervous system diseases, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc. 4. Severe sinusitis, nasal or sinus polyps, space-occupying lesions such as skull base or nasopharyngeal tumors; congenital malformations or history of trauma affecting the sense of smell in the nose, maxillofacial region, or skull base. No symptoms of upper respiratory tract infection (including nasal congestion, rhinorrhea, fever, etc.) on the day of MRI examination. 5. Acute complications of diabetes within the past 6 months, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, hypoglycemic coma, etc. 6. Severe impairment of organ function involving the heart, liver, or kidneys, including alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 × upper limit of normal; estimated glomerular filtration rate (eGFR) II within 3 months prior to screening. 7. History of recurrent urinary tract infection, severe gastrointestinal disease or gastrointestinal surgery, or history of malignancy. 8. Contraindications to MRI examination, such as implanted metal devices, claustrophobia, etc. 9. Pregnancy or breastfeeding. 10. Current participation or participation in another investigational drug trial within 6 months prior to enrollment. 11. Known or suspected allergy to the investigational product or related drugs. 12. History of alcohol or drug abuse within the past 6 months. 13. Use of SGLT2 inhibitors within 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The remission rate of mild cognitive impairment; | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE ;MoCA;RBANS;time of Trial Making Test;time of Stroop Color-Word Test;Barthle index;total brain volume measured by cranial MRI;total grey matter volume;total white matter volume;total cerebrospinal fluid volume;mean fractional anisotropy (FA) of white matter derived from diffusion tensor imaging (DTI);olfactory task-based fMRI activation of olfactory-related brain regions;functional connectivity of brain networks on resting-state fMRI;amyloid-beta (Aß) 42/40;p-tau 181;p-tau 217;glial fibrillary acidic protein;neurofilament light chain protein (NfL);HbA1c;fasting blood glucose;fasting insulin;fasting C-peptide;HOMA2-IR;HOMA2-ß;HOMA2-S;Fasting serum triglycerides;Total cholesterol;LDLC;HDLC;percentage of body fat;visceral fat area;weight;blood pressure;body mass index;waist circumference;Hip circumference;Waist-to-hip ratio; | — |
Countries
China
Contacts
Public ContactXiaoying Li
Zhongshan Hospital, Fudan University
Outcome results
None listed