NCT07385937

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Universidad Católica San Antonio de Murcia · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Alzheimer Disease (AD)
• Mild Cognitive Impairment (MCI)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2026-02-04
• Last updated: 2026-02-17

Locations

1 site across 1 country: Spain