Health TrialsbyHealthPanel

Effectiveness of Genistein in Mild Cognitive Impairment

ConditionsAlzheimer Disease (AD)Mild Cognitive Impairment (MCI)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Genistein

    Dietary supplement

    Soy isoflavone

  • Control product placebo

    Dietary supplement

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: GenisteinExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
From baseline to month 18

Secondary outcomes

1

Detection and assessment of cognitive impairment

The Mini-Mental State Examination (MMSE) is one of the most widely used tools for detecting and assessing cognitive impairment, including Alzheimer's disease. It is a brief and simple test that evaluates various cognitive functions: spatial and temporal orientation, immediate memory, attention and calculation, delayed memory, language, praxis (naming, repetition, comprehension of verbal commands, reading, spontaneous writing and copying drawings) and visual construction.

Time frame
18 months
2

Assess symptoms of depression

The GDS-15 (Geriatric Depression Scale - 15 items). This instrument was specifically designed for use in elderly populations to detect possible depression. It consists of 15 items with dichotomous yes/no responses.

Time frame
18 months
3

Severity of dementia

CDR-SB: A semi-structured interview with the primary informant and the patient, evaluated according to the evaluator's clinical judgment. It assesses the domains of Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, with greater emphasis on the first domain.

Time frame
18 months
4

global cognition

ADAS-Cog: This test aims to measure the severity of dementia (global cognition, memory, language, etc.). The ADAS-Cog14 was chosen, which adds additional items (delayed word recall, digit cancellation, and maze or verbal fluency test) to the original test, improving the scale's sensitivity without significantly increasing assessment time.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Católica San Antonio de Murcia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: