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NCT07385937Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
26 Jan 2026
Start date
Feb 2026
Primary completion date
Jul 2027
Lead sponsor
Universidad Católica San Antonio de Murcia
NCT number
NCT07385937

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From Feb 2026 to the primary completion date, Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.
  • Having a hormone-dependent neoplastic disease.
  • Diagnosis of significant cerebrovascular disease.
  • Having a serious systemic illness that would prevent completion of the study.

Other

  • Taking supplements containing isoflavones.

Who the study is looking for

  • 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.

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UCAM HiTech, Sport & Health Innovation Hub
Coordinator of this site? Confirm its status
MurciaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.