NCT07385937

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

January 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

January 26, 2026

Last Update Submit

February 12, 2026

Conditions

Mild Cognitive Impairment (MCI)Alzheimer Disease (AD)

Keywords

GenisteinDementiaCognitive impairmentNeuroprotectionPrevention

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    The primary variable to be evaluated is the change in overall cognitive function and the deterioration in the ability to perform activities of daily living, assessed through the mean change by the Integrated Alzheimer's Disease Rating Scale (iADRS) score. iADRS is an assessment tool designed to comprehensively measure cognitive and functional decline in patients with Alzheimer's disease, especially in the early stages. It combines elements of cognitive and functional assessment in a single scale, using ADAS-Cog and ADCS-ADL. In this case, version ADAS-Cog14 was used.

    From baseline to month 18

Secondary Outcomes (18)

  • Detection and assessment of cognitive impairment

    18 months

  • Assess symptoms of depression

    18 months

  • Severity of dementia

    18 months

  • global cognition

    18 months

  • Assess functionality in patients with cognitive impairment

    18 months

  • +13 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Control product placebo

Genistein

EXPERIMENTAL

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

Dietary Supplement: Genistein

Interventions

GenisteinDIETARY_SUPPLEMENT

Soy isoflavone

Genistein
Control product placeboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCAM HiTech, Sport & Health Innovation Hub

Murcia, Spain

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDementia

Interventions

Genistein

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

IsoflavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Francisco Javier López Román

CONTACT

968278157jlroman@ucam.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)