Effectiveness of Genistein in Mild Cognitive Impairment

Summary

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.

Interventions

• Genistein · DIETARY_SUPPLEMENT

  Soy isoflavone

• Control product placebo · DIETARY_SUPPLEMENT

  It will be supplied in a color and shape similar to the active product, but with maltodextrin, an inert substance.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• UCAM HiTech, Sport & Health Innovation Hub, Murcia, Spain