Effectiveness of Genistein in Mild Cognitive Impairment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversidad Católica San Antonio de Murcia
About this trial
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 criteria
Qualifiers
Patient over 50 years of age.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Genistein
- Control product placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov