Effectiveness of Genistein in Mild Cognitive Impairment

Effectiveness of Genistein on the Progression of Cognitive Impairment in Patients With Mild Cognitive Impairment: Controlled Clinical Trial

Randomized, placebo-controlled, double-blind, multicenter clinical trial with two parallel study arms (experimental and placebo) to assess the efficacy of genistein extract consumption over 18 months on cognitive decline in patients with prodromal Alzheimer's disease.

The study aims to evaluate the effect of genistein over 18 months compared to placebo on the progression of cognitive impairment in subjects diagnosed with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) in the following areas:

1. Global assessment of dementia: overall evaluation of functionality and cognitive decline in MCI subjects.
2. Global cognitive functions: assessment of general cognitive abilities.
3. Episodic memory: evaluation of memory performance.
4. Activities of daily living: assessment of the ability to perform basic and instrumental daily activities.
5. Emotional and depressive state: evaluation of subjects' mood and depressive symptoms

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.