NCT01982578: GENIAL

Genistein as a Possible Treatment for Alzheimer's Disease.

Completed NA Last updated 10 September 2021

What this trial tests

NA trial testing Genistein in Alzheimer's Disease in 27 participants. Completed in 31 December 2020.

Timeline

1 September 2017

Primary endpoint
30 September 2020

31 December 2020

Quick facts

Lead sponsor	Fundación para la Investigación del Hospital Clínico de Valencia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	27
Start date	1 September 2017
Primary completion	30 September 2020
Estimated completion	31 December 2020
Sites	2 locations across Spain

Drugs / interventions tested

• Genistein — full drug profile →
• Placebo

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Who can join

18 and older, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PPARγ/PGC1α signaling as a potential therapeutic target for mitochondrial biogenesis in neurodegenerative disorders.
   Jamwal S, Blackburn JK, Elsworth JD. · · 2021 · cited 189× · PMID 33039420 · DOI 10.1016/j.pharmthera.2020.107705
2. The roles of inflammation and immune mechanisms in Alzheimer's disease.
   Van Eldik LJ, Carrillo MC, Cole PE, Feuerbach D, et al · · 2016 · cited 154× · PMID 29067297 · DOI 10.1016/j.trci.2016.05.001
3. Flavonoids-Natural Gifts to Promote Health and Longevity.
   Fan X, Fan Z, Yang Z, Huang T, et al · · 2022 · cited 88× · PMID 35216290 · DOI 10.3390/ijms23042176
4. G Protein-Coupled Estrogen Receptor in Immune Cells and Its Role in Immune-Related Diseases.
   Notas G, Kampa M, Castanas E. · · 2020 · cited 70× · PMID 33133022 · DOI 10.3389/fendo.2020.579420
5. Genistein effect on cognition in prodromal Alzheimer's disease patients. The GENIAL clinical trial.
   Viña J, Escudero J, Baquero M, Cebrián M, et al · · 2022 · cited 53× · PMID 36329553 · DOI 10.1186/s13195-022-01097-2
6. Dietary Polyphenols as Therapeutic Intervention for Alzheimer's Disease: A Mechanistic Insight.
   Bukhari SNA. · · 2022 · cited 45× · PMID 35326204 · DOI 10.3390/antiox11030554
7. Potential Role of Polyphenolic Flavonoids as Senotherapeutic Agents in Degenerative Diseases and Geroprotection.
   Mbara KC, Devnarain N, Owira PMO. · · 2022 · cited 40× · PMID 36100824 · DOI 10.1007/s40290-022-00444-w
8. Targeting Alzheimer's disease with multimodal polypeptide-based nanoconjugates.
   Duro-Castano A, Borrás C, Herranz-Pérez V, Blanco-Gandía MC, et al · · 2021 · cited 39× · PMID 33771874 · DOI 10.1126/sciadv.abf9180