Effectiveness of Genistein in Mild Cognitive Impairment (EXTRAGENIAL)

Universidad Católica San Antonio de Murcia

Status: Not yet enrolling

Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease (AD)

Treatments: Dietary Supplement: Genistein; Dietary Supplement: Control product placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07385937

UCAMCFE-00040

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The product will have the same characteristics as the experimental product.

Treatment:

Dietary Supplement: Control product placebo

Genistein

Experimental group

Description:

Subjects will consume two capsules daily. Each capsule will be taken before the two main meals, each 100 mg tablet.

Treatment:

Dietary Supplement: Genistein