NCT07385937 · NOT YET RECRUITING
Effectiveness of Genistein in Mild Cognitive Impairment
This trial is testing whether taking a genistein supplement, a plant compound found in soy, for 18 months slows cognitive decline in people with mild cognitive impairment from early Alzheimer's. Some people get genistein and some get a placebo. No phase is assigned, so it isn't a standard drug-stage trial. It is not proven or approved for this.
Eligibility criteria
Inclusion Criteria: * Patient over 50 years of age. * Patient diagnosed with mild cognitive impairment (MCI) for Alzheimer's disease (AD) according to the National Institute on Aging and Alzheimer's Association (NIA-AA, 2024) criteria: * MMSE scores between 22 and 30 (inclusive; exceptions may be made for subjects with less than 5 years of education). * Evidence of concern about change in cognition, compared to the person's previous level (subjective memory complaint/impairment for more than 6 months in the past year and/or confirmed by the informant and/or physician). * A Clinical Dementia Rating (CDR) score of 0.5 with a memory domain score of 0.5. * Essentially preserved activities of daily living. * Evidence of elevated cortical amyloid by positron emission tomography (PET) with F18-flutemetamol. • Patients will be treated pharmaceutically according to the guidelines. Exclusion Criteria: * Diagnosis of a significant neurological disease other than Alzheimer's disease. * Moderate depression as assessed by a Geriatric Depression Scale (GDS-D) score >8, or any other serious psychiatric disorder. * Taking supplements containing isoflavones. * Having a hormone-dependent neoplastic disease. * Diagnosis of significant cerebrovascular disease. * Having a serious systemic illness that would prevent completion of the study.
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 2026-02-17