NCT06444568 · RECRUITING
Modified Ketogenic Diet in Amnestic Mild Cognitive Impairments
This trial is testing whether a 12-week modified ketogenic diet improves memory and thinking in older adults with amnestic mild cognitive impairment. Participants are compared against two control groups: one following the MIND diet, one making no changes. Phase NA means this is a practical intervention study, not a drug trial moving through standard approval phases. It is small, with 36 participants total, so results will be preliminary.
You may qualify if
- 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.
You're excluded if
- 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.)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-11-25