Effects of Olfactory Training on the Brain Function in T2DM Patients With Mild Cognitive Impairment (NCT06327633) | Clinical Trial Compass
CompletedNot Applicable
Effects of Olfactory Training on the Brain Function in T2DM Patients With Mild Cognitive Impairment
China60 participantsStarted 2024-01-01
Plain-language summary
This is a prospective, randomized, open label, parallel, 4-month study to explore and evaluate the therapeutic effects of olfactory training on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with mild cognitive impairment (MCI).
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion Criteria:
* patients with type 2 diabetes mellitus;
* Aged: 40 -75 years ;
* Cognitive function assessment suggests mild cognitive impairment;
* A stable glucose-lowering regimen for more than 2 months;
* ≥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 essential oil;
* Taking cognitive-related …
What they're measuring
1
Change of cognitive function (evaluated by MoCA score)
Timeframe: from baseline to 4-month follow-up
Trial details
NCT IDNCT06327633
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School