Impact of the Combined Treatment of Liposomed Polyphenols With G04CB02 on the ALS Patients

NCT04654689 | Completed Phase 2 FDA Drug

• 2 other identifiers: UCV/2020-2021/0182020-005143-23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Amyotrophic lateral sclerosis (ALS) is a disease of an inflammatory nature, which causes progressive muscle weakness associated with cognitive and behavioural disorders. Pathogenically, it is characterised by loss of oxidative control, excitotoxicity due to excess glutamate and intestinal dysbiosis. In the absence of curative treatment, the aim of the study is to assess the impact at a clinical level of the combination of liposomed polyphenols to improve their effectiveness, with the drug G04CB02 which shows great anti-ALS properties by Molecular Topology methodology. A prospective, longitudinal, mixed, analytical, experimental and double-blind study is proposed, with a population sample of 60 patients distributed randomly in 30 patients in the intervention group who will receive treatment for 2 months, and 30 patients in the control group who will receive a placebo for the same period. The assessment will be at time 0, and at 2 months and 4 months after treatment, with functional, cognitive and behavioural tests, and of the state of inflammation and oxidation; and at time 0 and 2 months, of the intestinal microbiota.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (9)

• Revised Amyotrophic Lateral Sclerosis Functional Rating Scale associated with ALS

  Maximum value: 48 points; Means better outcome motor variables Minimum value: 0 points

  Time 0

• Revised Amyotrophic Lateral Sclerosis Functional Rating Scale associated with ALS

  Maximum value: 48 points; Means better outcome motor variables Minimum value: 0 points

  2 months

• Revised Amyotrophic Lateral Sclerosis Functional Rating Scale associated with ALS

  Maximum value: 48 points; Means better outcome motor variables Minimum value: 0 points

  4 months

• Electromyography

  Motor Variables

  Time 0

• Electromyography

  Motor Variables

  2 months

• Electromyography

  Motor Variables

  4 months

• Measurement of forced vital capacity

  Motor Variables

  Time 0

• Measurement of forced vital capacity

  Motor Variables

  2 months

• Measurement of forced vital capacity

  Motor Variables

  4 months

Secondary Outcomes (24)

• Quantitative measurement of plasma IL-6 and TNF-alpha.

  Time 0

• Quantitative measurement of plasma IL-6 and TNF-alpha.

  2 months

• Quantitative measurement of plasma IL-6 and TNF-alpha.

  4 months

• Quantitative measurement of plasma PCR.

  Time 0

• Quantitative measurement of plasma PCR.

  2 months

Other Outcomes (2)

• Variables related to the microbiota

  Time 0

• Variables related to the microbiota

  4 months

Study Arms (2)

Intervention group

EXPERIMENTAL

30 patients will be given the combination of resveratrol and curcumin liposomed with G04CB02, in a single daily dose for 2 months.

Dietary Supplement: Liposomed polyphenols resveratrol and curcumin; Dietary Supplement: Isocaloric Diet; Drug: G04CB02

Control group

PLACEBO COMPARATOR

30 patients, who will receive a placebo with the same dosage pattern and for the same period of time. The placebo will consist of water with sucrose replacing the liposomal polyphenols, and a soft capsule of microcrystalline methylcellulose instead of G04CB02. Both the packaging and the capsule format will be identical to those of the treatment administered in the intervention group

Other: Placebo for liposomed resveratrol and curcumin; Dietary Supplement: Isocaloric Diet; Other: Placebo microcrystalline methylcellulose

Interventions

Liposomed polyphenols resveratrol and curcumin DIETARY_SUPPLEMENT

Combination of resveratrol (75mg) and curcumin (200mg) liposomed

Intervention group

Placebo for liposomed resveratrol and curcumin OTHER

Water with sucrose replacing the liposomed polyphenols

Control group

Isocaloric Diet DIETARY_SUPPLEMENT

40% carbohydrates, 40% lipids and 20% proteins

Control group; Intervention group

G04CB02 DRUG

G04CB02, in a single daily dose for 2 months

Intervention group

Placebo microcrystalline methylcellulose OTHER

Placebo replacing G04CB02

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All ALS patients, over 18 years of age and with a clear diagnosis and symptomatology of ALS since at least 6 months.

You may not qualify if:

• Women under 50 years of age and childbearing age.
• Tracheotomy patients.
• Patients with invasive or non-invasive ventilation with positive ventilatory pressure
• Patients with evidence of dementia.
• Patients with alcohol or drug abuse dependency.
• Patients infected with B or C hepatitis, or HIV positive
• Renal patients with creatinine levels twice as high as normal markers.
• Liver patients with liver markers (ALT, AST) elevated 3 times above normal levels.
• Patients included in other research with drugs or therapies in the experimental phase.
• Patients treated with anticoagulants or with haemostatic problems

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

José Enrique de la Rubia Ortí

Valencia, Valencia, 46007, Spain

Location

Related Publications (54)

• Riancho J, Gonzalo I, Ruiz-Soto M, Berciano J. Why do motor neurons degenerate? Actualization in the pathogenesis of amyotrophic lateral sclerosis. Neurologia (Engl Ed). 2019 Jan-Feb;34(1):27-37. doi: 10.1016/j.nrl.2015.12.001. Epub 2016 Feb 4. English, Spanish.

  PMID: 26853842 BACKGROUND

• Gordon PH. Amyotrophic Lateral Sclerosis: An update for 2013 Clinical Features, Pathophysiology, Management and Therapeutic Trials. Aging Dis. 2013 Oct 1;4(5):295-310. doi: 10.14336/AD.2013.0400295.

  PMID: 24124634 BACKGROUND

• Woolley SC, Jonathan S Katz. Cognitive and behavioral impairment in amyotrophic lateral sclerosis. Phys Med Rehabil Clin N Am. 2008 Aug;19(3):607-17, xi. doi: 10.1016/j.pmr.2008.04.002.

  PMID: 18625419 BACKGROUND

• Phukan J, Pender NP, Hardiman O. Cognitive impairment in amyotrophic lateral sclerosis. Lancet Neurol. 2007 Nov;6(11):994-1003. doi: 10.1016/S1474-4422(07)70265-X.

  PMID: 17945153 BACKGROUND

• Ralli M, Lambiase A, Artico M, de Vincentiis M, Greco A. Amyotrophic Lateral Sclerosis: Autoimmune Pathogenic Mechanisms, Clinical Features, and Therapeutic Perspectives. Isr Med Assoc J. 2019 Jul;21(7):438-443.

  PMID: 31507117 BACKGROUND

• Ticinesi A, Nouvenne A, Tana C, Prati B, Meschi T. Gut Microbiota and Microbiota-Related Metabolites as Possible Biomarkers of Cognitive Aging. Adv Exp Med Biol. 2019;1178:129-154. doi: 10.1007/978-3-030-25650-0_8.

  PMID: 31493226 BACKGROUND

• Alifirova VM, Zhukova NG, Zhukova IA, Mironova YS, Petrov VA, Izhboldina OP, Titova MA, Latypova AV, Nikitina MA, Dorofeeva YB, Saltykova IV, Tyakht AV, Kostryukova ES, Sazonov AE. [Correlation Between Emotional-Affective Disorders and Gut Microbiota Composition in Patients with Parkinson's Disease]. Vestn Ross Akad Med Nauk. 2016;71(6):427-35. doi: 10.15690/vramn734. Russian.

  PMID: 29298003 BACKGROUND

• Spielman LJ, Gibson DL, Klegeris A. Unhealthy gut, unhealthy brain: The role of the intestinal microbiota in neurodegenerative diseases. Neurochem Int. 2018 Nov;120:149-163. doi: 10.1016/j.neuint.2018.08.005. Epub 2018 Aug 14.

  PMID: 30114473 BACKGROUND

• Roy Sarkar S, Banerjee S. Gut microbiota in neurodegenerative disorders. J Neuroimmunol. 2019 Mar 15;328:98-104. doi: 10.1016/j.jneuroim.2019.01.004. Epub 2019 Jan 9.

  PMID: 30658292 BACKGROUND

• Mazzini L, Mogna L, De Marchi F, Amoruso A, Pane M, Aloisio I, Cionci NB, Gaggia F, Lucenti A, Bersano E, Cantello R, Di Gioia D, Mogna G. Potential Role of Gut Microbiota in ALS Pathogenesis and Possible Novel Therapeutic Strategies. J Clin Gastroenterol. 2018 Nov/Dec;52 Suppl 1, Proceedings from the 9th Probiotics, Prebiotics and New Foods, Nutraceuticals and Botanicals for Nutrition & Human and Microbiota Health Meeting, held in Rome, Italy from September 10 to 12, 2017:S68-S70. doi: 10.1097/MCG.0000000000001042.

  PMID: 29782468 BACKGROUND

• Wright ML, Fournier C, Houser MC, Tansey M, Glass J, Hertzberg VS. Potential Role of the Gut Microbiome in ALS: A Systematic Review. Biol Res Nurs. 2018 Oct;20(5):513-521. doi: 10.1177/1099800418784202. Epub 2018 Jun 20.

  PMID: 29925252 BACKGROUND

• Erber AC, Cetin H, Berry D, Schernhammer ES. The role of gut microbiota, butyrate and proton pump inhibitors in amyotrophic lateral sclerosis: a systematic review. Int J Neurosci. 2020 Jul;130(7):727-735. doi: 10.1080/00207454.2019.1702549. Epub 2019 Dec 23.

  PMID: 31870202 BACKGROUND

• Blacher E, Bashiardes S, Shapiro H, Rothschild D, Mor U, Dori-Bachash M, Kleimeyer C, Moresi C, Harnik Y, Zur M, Zabari M, Brik RB, Kviatcovsky D, Zmora N, Cohen Y, Bar N, Levi I, Amar N, Mehlman T, Brandis A, Biton I, Kuperman Y, Tsoory M, Alfahel L, Harmelin A, Schwartz M, Israelson A, Arike L, Johansson MEV, Hansson GC, Gotkine M, Segal E, Elinav E. Potential roles of gut microbiome and metabolites in modulating ALS in mice. Nature. 2019 Aug;572(7770):474-480. doi: 10.1038/s41586-019-1443-5. Epub 2019 Jul 22.

  PMID: 31330533 BACKGROUND

• de la Rubia JE, Drehmer E, Platero JL, Benlloch M, Caplliure-Llopis J, Villaron-Casales C, de Bernardo N, AlarcOn J, Fuente C, Carrera S, Sancho D, GarcIa-Pardo P, Pascual R, JuArez M, Cuerda-Ballester M, Forner A, Sancho-Castillo S, Barrios C, Obrador E, Marchio P, Salvador R, Holmes HE, Dellinger RW, Guarente L, Estrela JM. Efficacy and tolerability of EH301 for amyotrophic lateral sclerosis: a randomized, double-blind, placebo-controlled human pilot study. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Feb;20(1-2):115-122. doi: 10.1080/21678421.2018.1536152. Epub 2019 Jan 22.

  PMID: 30668199 BACKGROUND

• Song W, Song Y, Kincaid B, Bossy B, Bossy-Wetzel E. Mutant SOD1G93A triggers mitochondrial fragmentation in spinal cord motor neurons: neuroprotection by SIRT3 and PGC-1alpha. Neurobiol Dis. 2013 Mar;51:72-81. doi: 10.1016/j.nbd.2012.07.004. Epub 2012 Jul 20.

  PMID: 22819776 BACKGROUND

• Asensi M, Medina I, Ortega A, Carretero J, Bano MC, Obrador E, Estrela JM. Inhibition of cancer growth by resveratrol is related to its low bioavailability. Free Radic Biol Med. 2002 Aug 1;33(3):387-98. doi: 10.1016/s0891-5849(02)00911-5.

  PMID: 12126761 BACKGROUND

• Poltronieri P, Xu B, Giovinazzo G. Resveratrol and other Stilbenes: Effects on Dysregulated Gene Expression in Cancers and Novel Delivery Systems. Anticancer Agents Med Chem. 2021;21(5):567-574. doi: 10.2174/1871520620666200705220722.

  PMID: 32628597 BACKGROUND

• Chico L, Ienco EC, Bisordi C, Lo Gerfo A, Petrozzi L, Petrucci A, Mancuso M, Siciliano G. Amyotrophic Lateral Sclerosis and Oxidative Stress: A Double-Blind Therapeutic Trial After Curcumin Supplementation. CNS Neurol Disord Drug Targets. 2018;17(10):767-779. doi: 10.2174/1871527317666180720162029.

  PMID: 30033879 BACKGROUND

• Ahmadi M, Agah E, Nafissi S, Jaafari MR, Harirchian MH, Sarraf P, Faghihi-Kashani S, Hosseini SJ, Ghoreishi A, Aghamollaii V, Hosseini M, Tafakhori A. Safety and Efficacy of Nanocurcumin as Add-On Therapy to Riluzole in Patients With Amyotrophic Lateral Sclerosis: A Pilot Randomized Clinical Trial. Neurotherapeutics. 2018 Apr;15(2):430-438. doi: 10.1007/s13311-018-0606-7.

  PMID: 29352425 BACKGROUND

• Huang M , Liang C , Tan C , Huang S , Ying R , Wang Y , Wang Z , Zhang Y . Liposome co-encapsulation as a strategy for the delivery of curcumin and resveratrol. Food Funct. 2019 Oct 16;10(10):6447-6458. doi: 10.1039/c9fo01338e.

  PMID: 31524893 BACKGROUND

• Narayanan NK, Nargi D, Randolph C, Narayanan BA. Liposome encapsulation of curcumin and resveratrol in combination reduces prostate cancer incidence in PTEN knockout mice. Int J Cancer. 2009 Jul 1;125(1):1-8. doi: 10.1002/ijc.24336.

  PMID: 19326431 BACKGROUND

• Zam W. Gut Microbiota as a Prospective Therapeutic Target for Curcumin: A Review of Mutual Influence. J Nutr Metab. 2018 Dec 16;2018:1367984. doi: 10.1155/2018/1367984. eCollection 2018.

  PMID: 30647970 BACKGROUND

• Luca SV, Macovei I, Bujor A, Miron A, Skalicka-Wozniak K, Aprotosoaie AC, Trifan A. Bioactivity of dietary polyphenols: The role of metabolites. Crit Rev Food Sci Nutr. 2020;60(4):626-659. doi: 10.1080/10408398.2018.1546669. Epub 2019 Jan 7.

  PMID: 30614249 BACKGROUND

• Chen ML, Yi L, Zhang Y, Zhou X, Ran L, Yang J, Zhu JD, Zhang QY, Mi MT. Resveratrol Attenuates Trimethylamine-N-Oxide (TMAO)-Induced Atherosclerosis by Regulating TMAO Synthesis and Bile Acid Metabolism via Remodeling of the Gut Microbiota. mBio. 2016 Apr 5;7(2):e02210-15. doi: 10.1128/mBio.02210-15.

  PMID: 27048804 BACKGROUND

• Qiao Y, Sun J, Xia S, Tang X, Shi Y, Le G. Effects of resveratrol on gut microbiota and fat storage in a mouse model with high-fat-induced obesity. Food Funct. 2014 Jun;5(6):1241-9. doi: 10.1039/c3fo60630a. Epub 2014 Apr 11.

  PMID: 24722352 BACKGROUND

• Sung MM, Byrne NJ, Robertson IM, Kim TT, Samokhvalov V, Levasseur J, Soltys CL, Fung D, Tyreman N, Denou E, Jones KE, Seubert JM, Schertzer JD, Dyck JR. Resveratrol improves exercise performance and skeletal muscle oxidative capacity in heart failure. Am J Physiol Heart Circ Physiol. 2017 Apr 1;312(4):H842-H853. doi: 10.1152/ajpheart.00455.2016. Epub 2017 Feb 3.

  PMID: 28159807 BACKGROUND

• Zhao L, Zhang Q, Ma W, Tian F, Shen H, Zhou M. A combination of quercetin and resveratrol reduces obesity in high-fat diet-fed rats by modulation of gut microbiota. Food Funct. 2017 Dec 13;8(12):4644-4656. doi: 10.1039/c7fo01383c.

  PMID: 29152632 BACKGROUND

• Slater S, Dumas C, Bubley G. Dutasteride for the treatment of prostate-related conditions. Expert Opin Drug Saf. 2012 Mar;11(2):325-30. doi: 10.1517/14740338.2012.658040. Epub 2012 Feb 8.

  PMID: 22316171 BACKGROUND

• Arif T, Dorjay K, Adil M, Sami M. Dutasteride in Androgenetic Alopecia: An Update. Curr Clin Pharmacol. 2017;12(1):31-35. doi: 10.2174/1574884712666170310111125.

  PMID: 28294070 BACKGROUND

• Zanni R, Galvez-Llompart M, Garcia-Domenech R, Galvez J. What place does molecular topology have in today's drug discovery? Expert Opin Drug Discov. 2020 Oct;15(10):1133-1144. doi: 10.1080/17460441.2020.1770223. Epub 2020 Jun 4.

  PMID: 32496823 BACKGROUND

• Salehi B, Mishra AP, Nigam M, Sener B, Kilic M, Sharifi-Rad M, Fokou PVT, Martins N, Sharifi-Rad J. Resveratrol: A Double-Edged Sword in Health Benefits. Biomedicines. 2018 Sep 9;6(3):91. doi: 10.3390/biomedicines6030091.

  PMID: 30205595 BACKGROUND

• Patel KR, Scott E, Brown VA, Gescher AJ, Steward WP, Brown K. Clinical trials of resveratrol. Ann N Y Acad Sci. 2011 Jan;1215:161-9. doi: 10.1111/j.1749-6632.2010.05853.x.

  PMID: 21261655 BACKGROUND

• Kuptniratsaikul V, Thanakhumtorn S, Chinswangwatanakul P, Wattanamongkonsil L, Thamlikitkul V. Efficacy and safety of Curcuma domestica extracts in patients with knee osteoarthritis. J Altern Complement Med. 2009 Aug;15(8):891-7. doi: 10.1089/acm.2008.0186.

  PMID: 19678780 BACKGROUND

• Deshpande SS, Lalitha VS, Ingle AD, Raste AS, Gadre SG, Maru GB. Subchronic oral toxicity of turmeric and ethanolic turmeric extract in female mice and rats. Toxicol Lett. 1998 May;95(3):183-93. doi: 10.1016/s0378-4274(98)00035-6.

  PMID: 9704820 BACKGROUND

• Hewlings SJ, Kalman DS. Curcumin: A Review of Its Effects on Human Health. Foods. 2017 Oct 22;6(10):92. doi: 10.3390/foods6100092.

  PMID: 29065496 BACKGROUND

• Chung HT, Noworolski SM, Kurhanewicz J, Weinberg V, Roach Iii M. A pilot study of endorectal magnetic resonance imaging and magnetic resonance spectroscopic imaging changes with dutasteride in patients with low risk prostate cancer. BJU Int. 2011 Oct;108(8 Pt 2):E164-70. doi: 10.1111/j.1464-410X.2010.10061.x. Epub 2011 Mar 24.

  PMID: 21435153 BACKGROUND

• Perrotti M, Jain R, Abriel LM, Baroni TE, Corbett AB, Tenenbaum SA. Dutasteride monotherapy in men with serologic relapse following radical therapy for adenocarcinoma of the prostate: a pilot study. Urol Oncol. 2012 Mar-Apr;30(2):133-8. doi: 10.1016/j.urolonc.2010.01.004. Epub 2010 Aug 25.

  PMID: 20800512 BACKGROUND

• Kaufmann P, Levy G, Montes J, Buchsbaum R, Barsdorf AI, Battista V, Arbing R, Gordon PH, Mitsumoto H, Levin B, Thompson JL; QALS study group. Excellent inter-rater, intra-rater, and telephone-administered reliability of the ALSFRS-R in a multicenter clinical trial. Amyotroph Lateral Scler. 2007 Feb;8(1):42-6. doi: 10.1080/17482960600888156.

  PMID: 17364435 BACKGROUND

• Montes J, Levy G, Albert S, Kaufmann P, Buchsbaum R, Gordon PH, Mitsumoto H. Development and evaluation of a self-administered version of the ALSFRS-R. Neurology. 2006 Oct 10;67(7):1294-6. doi: 10.1212/01.wnl.0000238505.22066.fc.

  PMID: 17030772 BACKGROUND

• Witgert M, Salamone AR, Strutt AM, Jawaid A, Massman PJ, Bradshaw M, Mosnik D, Appel SH, Schulz PE. Frontal-lobe mediated behavioral dysfunction in amyotrophic lateral sclerosis. Eur J Neurol. 2010 Jan;17(1):103-10. doi: 10.1111/j.1468-1331.2009.02801.x. Epub 2009 Oct 29.

  PMID: 19874396 BACKGROUND

• Butman J, Allegri RF, Harris P, Drake M. [Spanish verbal fluency. Normative data in Argentina]. Medicina (B Aires). 2000;60(5 Pt 1):561-4. Spanish.

  PMID: 11188892 BACKGROUND

• Mahone EM, Cirino PT, Cutting LE, Cerrone PM, Hagelthorn KM, Hiemenz JR, Singer HS, Denckla MB. Validity of the behavior rating inventory of executive function in children with ADHD and/or Tourette syndrome. Arch Clin Neuropsychol. 2002 Oct;17(7):643-62.

  PMID: 14591848 BACKGROUND

• Portella MJ, Marcos-Bars T, Rami-Gonzalez L, Navarro-Odriozola V, Gasto-Ferrer C, Salamero M. ['Tower of London': mental planning, validity and the ceiling effect]. Rev Neurol. 2003 Aug 1-15;37(3):210-3. Spanish.

  PMID: 12938051 BACKGROUND

• Ringholz GM, Appel SH, Bradshaw M, Cooke NA, Mosnik DM, Schulz PE. Prevalence and patterns of cognitive impairment in sporadic ALS. Neurology. 2005 Aug 23;65(4):586-90. doi: 10.1212/01.wnl.0000172911.39167.b6.

  PMID: 16116120 BACKGROUND

• Stout JC, Ready RE, Grace J, Malloy PF, Paulsen JS. Factor analysis of the frontal systems behavior scale (FrSBe). Assessment. 2003 Mar;10(1):79-85. doi: 10.1177/1073191102250339.

  PMID: 12675387 BACKGROUND

• Galvez, Jorge; Llompart, Javier; Land, David; Pasinetti, Giulio. Compositions for treatment of Alzheimer's disease using AB-reducing and/or AB-anti-aggregation compounds. WO 2010114636 A1 20101636. 2010

  BACKGROUND

• Galvez, Jorge; Llompart, Javier; Pal, Kollol. N,N-dicyclohexyl-(1S)-isoborneol-10-sulfonamide (MT103) and related compounds for the treatment of cancer. US20040266732. 2004

  BACKGROUND

• Llompart, Javier; Galvez, Jorge; Pal, Kollol. Treatment of cancer with MT477 derivatives. US20060014770. 2006

  BACKGROUND

• Gastaminza, P; Garaigorta, U., Benlloch, J.M., Galvez-Llompart, M; Zanni, R, and Galvez, J. Compounds for the treatment and prevention of viral infections caused by coronaviruses. European Patent Application EP20382570.8. 2020

  BACKGROUND

• Jiménez J, Hernández S, Garcia E, Diaz A, Rodriguez C. Test de atención D2: Datos normativos y desarrollo evolutivo de la atención.Eur J Educ Psychol. 2012; 5: 93-106.

  BACKGROUND

• Martin R, Hernández S, Rodriguez C, Garcia E. Datos normativos para el Test de Stroop: patrón de desarrollo de la inhibición y formas alternativas para su evaluación. Eur J Educ Psychol. 2012; 5: 39-51

  BACKGROUND

• Wechsler D. WMS-R: Wechsler Memory Scale-Revised Manual. 1987. San Antonio: The Psychological Corporation

  BACKGROUND

• Sancho-Cantus D, Sanchis ES, Casani-Cubel J, Privado J, Escriba J, Carriqui-Suarez AB, Benlloch M, Ceron JJ, Rubio CP, Cubero-Plazas L, de la Rubia Orti JE. Prediction of antioxidant capacity, age, and sex on sleep impairment in patients with amyotrophic lateral sclerosis. Sci Rep. 2025 Jul 1;15(1):21145. doi: 10.1038/s41598-025-07729-5.

  PMID: 40595276 DERIVED

• Privado J, Sanchis Sanchis E, Sancho-Cantus D, Cubero-Plazas L, Navarro-Illana E, de la Rubia Orti JE. Prediction of caregiver psychological distress in amyotrophic lateral sclerosis: A cross-sectional study. Rehabil Psychol. 2024 Nov;69(4):364-374. doi: 10.1037/rep0000554. Epub 2024 Jun 20.

  PMID: 38900570 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• José Enrique De la Rubia Ortí, Ph

  Catholic University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: * Intervention group: 30 patients will be administered daily the combination of Resveratrol (75mg) and Curcumin (200mg) liposomes with G04CB02 (0.5mg), in a single dose for 2 months. * Control group: 30 patients, who will receive a placebo with the same dosage pattern and for the same period of time. The placebo will consist of water with sucrose replacing the liposomed polyphenols, and a soft capsule of microcrystalline methylcellulose instead of G04CB02. Both the packaging and the capsule format will be identical to those of the treatment administered in the intervention group.

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 4, 2020
• Study Start: November 20, 2021
• Primary Completion: November 12, 2022
• Study Completion: February 4, 2023
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)