Effectiveness of Genistein on the Progression of Cognitive Impairment in Patients With Mild Cognitive Impairment: Controlled Clinical Trial
NCT: NCT07385937 ·
Status: NOT YET RECRUITING ·
Phase: N/A
· Sponsor: Universidad Católica San Antonio de Murcia
· Started: 2026-02
· Est. Completion: 2027-12
Official 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.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: TRIPLE
- Enrollment: 150 participants
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 Outcomes
- Cognitive function (From baseline to month 18)
Secondary Outcomes
- 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)
Trial Locations
- UCAM HiTech, Sport & Health Innovation Hub, Murcia, Spain
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.