NCT01982578

Brief Summary

Genistein is an isoflavone that has antioxidant and neuroprotective effects on Alzheimer's disease (AD). A few years ago our group reported that genistein increased PPARg (peroxisome proliferator activated receptor gamma) levels. By the way, activation of retinoid X receptor (RXR)-PPARg dimer, will make overexpressing apolipoprotein E (apoE), which mediates the degradation of amyloid beta (AB). Therefore, we believe that if this phytoestrogen administration increases the availability of the transcription factor, it can increase apoE, and also AB degradation. The main aim of this study is to determinate the effect of 60 mg BID of genistein administration, during 360 days, compared to placebo group, in AD patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
3.8 years until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

3.1 years

First QC Date

October 30, 2013

Last Update Submit

September 9, 2021

Conditions

Alzheimer's Disease

Keywords

TreatmentGenisteinAlzheimer's diseaseCerebrospinal fluidAmyloid beta

Outcome Measures

Primary Outcomes (1)

  • Changes in Amyloid beta concentration in cerebrospinal fluid (CSF)

    The primary study endpoint is the change from baseline to the end of the treatment, and the change between the treatment group and the placebo group.

    Day 0 and day 360 (plus or minus 7 day)

Secondary Outcomes (8)

  • Changes in MMSE.

    Day 0, day 180, day 360, (plus or minus 7 days)

  • Changes in T@M (Memory Alteration Test).

    Day 0, day 180, day 360, (plus or minus 7 days)

  • Changes in TAVEC (Verbal Learning Test Spain-COmplutense).

    Day 0, day 180, day 360, (plus or minus 7 days)

  • Changes in the Clock test.

    Day 0, day 180, day 360, (plus or minus 7 days)

  • Changes in the Barcelona Test.

    Day 0, day 180, day 360, (plus or minus 7 days)

  • +3 more secondary outcomes

Study Arms (2)

Product: Genistein

EXPERIMENTAL

60 mg of genistein BID for 360 days. Intervention: Product: Genistein

Dietary Supplement: Genistein

Product: Placebo

PLACEBO COMPARATOR

1 placebo capsule BID for 360 days. Intervention: Product: Placebo

Other: Placebo

Interventions

GenisteinDIETARY_SUPPLEMENT

Subjects will be randomized 1:1 to receive 360 days of double blind treatment of genistein.

Also known as: Fisiogen
Product: Genistein
PlaceboOTHER

360 days of double blind treatment of placebo.

Product: Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild cognitive impairment (MCI) compatible with prodromal AD.
  • Mini-Mental State Examinations (MMSE) score between over 24 inclusive.
  • CSF levels of AB, p-TAU compatible with AD.
  • years or older.
  • Must have a study partner who is able and willing to comply with all required study procedures.
  • Willing and able to provide informed consent by either the subject or subject's legal representative.

You may not qualify if:

  • Thyroid abnormalities with or without treatment.
  • Immune abnormalities in blood analyses.
  • Patient suffers hormone dependent neoplasia.
  • Take a diet rich on isoflavones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitat de València

Valencia, 46010, Spain

Location

Hospital General Universitario

Valencia, Spain

Location

Related Publications (1)

  • Vina J, Escudero J, Baquero M, Cebrian M, Carbonell-Asins JA, Munoz JE, Satorres E, Melendez JC, Ferrer-Rebolleda J, Cozar-Santiago MDP, Santabarbara-Gomez JM, Jove M, Pamplona R, Tarazona-Santabalbina FJ, Borras C. Genistein effect on cognition in prodromal Alzheimer's disease patients. The GENIAL clinical trial. Alzheimers Res Ther. 2022 Nov 4;14(1):164. doi: 10.1186/s13195-022-01097-2.

    PMID: 36329553DERIVED

MeSH Terms

Conditions

Alzheimer DiseasePlaque, Amyloid

Interventions

Genistein

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IsoflavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jose Viña, MD PhD (hon)

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor M.D. Ph. D. (hon)

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 13, 2013

Study Start

September 1, 2017

Primary Completion

September 30, 2020

Study Completion

December 31, 2020

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

ES(2)