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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT06444568
Eligibility Criteria:
Inclusion Criteria:
* Having been diagnosed with "amnestic mild cognitive impairment/disorder (aMCI)" by the clinician after the evaluation of cognitive functions according to the neuropsychological evaluation method (0.5 according to the Clinical Dementia Rating Scale (CDR).)
* Having at least 6 years of education.
Exclusion Criteria:
* Under the age of 65 or over the age of 80.
* Diagnosis of neurological (other than MCI) or psychological diseases.
* GDS-15 score \> 5 (baseline)
* Kidney/pancreas/liver diseases or dysfunctions, Type 1 diabetes (and Type II diabetic patients receiving insulin replacement therapy), cancer, metabolic diseases (fatty acid oxidation defect, etc.), thyroid dysfunction, pulmonary or autoimmune diseases, head trauma, history of any cardiovascular event (i.e., stroke, myocardial infarction) in the last year.
* Hypercholesterolemia (fasting T-C \>300 mg/dL or LDL-C \>200 mg/dL), non-reference B12 or folate levels according to biochemical tests performed in the last year.
* Nutritional risks (chewing/swallowing difficulties, history of involuntary weight loss in the last 6 months, body mass index \< 22 kg/m2).
* Use of internal device/implant (pacemaker or hearing aid, etc.).
* Medication use (individuals using anticholinergic, antidementia, and opioid class drugs will be excluded; individuals using antidepressant class drugs will be included in the study on the condition that it has been continued for at least 3 months and there is no change in drug type and dose during the study protocol.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
80 Years
Study:
NCT06444568
Study Brief:
Protocol Section:
NCT06444568