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Not yet recruiting NCT07385937

Effectiveness of Genistein in Mild Cognitive Impairment

No phase Interventional Alzheimer Disease (AD) Mild Cognitive Impairment (MCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Genistein, Control product placebo.
Who it may be relevant to
Registry conditions: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI). Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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

Interventions

  • Dietary supplement Genistein
    Soy isoflavone
  • Dietary supplement Control product placebo
    It will be supplied in a color and shape similar to the active product, but with maltodextrin, an inert substance.

Primary outcome measures

  • Cognitive function [Time frame: From baseline to month 18]
Secondary outcome measures (12)
  • Detection and assessment of cognitive impairment [Time frame: 18 months]
  • Assess symptoms of depression [Time frame: 18 months]
  • Severity of dementia [Time frame: 18 months]
  • global cognition [Time frame: 18 months]
  • Assess functionality in patients with cognitive impairment [Time frame: 18 months]
  • Activities of daily living [Time frame: 18 months]
  • Assess verbal memory [Time frame: 18 months]
  • Assess cognitive functions [Time frame: 18 months]
  • visuospatial abilities and visual memory [Time frame: 18 months]
  • Assess visual memory, visuospatial perception, and executive functions [Time frame: 18 months]
  • Working memory and attention [Time frame: 18 months]
  • Ability to generate words within a specific category [Time frame: 18 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Spain · 1 center
  • UCAM HiTech, Sport & Health Innovation Hub — Murcia

Identifiers

NCT: NCT07385937 · UCAMCFE-00040

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗