Control product placebo: It will be supplied in a color and shape similar to the active product, but with maltodextrin, an inert substance.
Study 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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Cognitive function — From baseline to month 18 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.
Trial sites (1)
Facility
City
Region
Status
UCAM HiTech, Sport & Health Innovation Hub
Murcia
Spain
More Universidad Católica San Antonio de Murcia trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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