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

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ClinicalTrials.gov Identifier: NCT04654689
Recruitment Status : Not yet recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
José Enrique de la Rubia Ortí, Fundación Universidad Católica de Valencia San Vicente Mártir

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 Dutasteride 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 100 patients distributed randomly in 50 patients in the intervention group who will receive treatment for 6 months, and 50 patients in the control group who will receive a placebo for the same period. The assessment will be at time 0, and at 3 months and 6 months after treatment, with functional, cognitive and behavioural tests, and of the state of inflammation and oxidation; and at time 0 and 6 months, of the intestinal microbiota.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Dietary Supplement: Liposomed polyphenols resveratrol and curcumin Other: Placebo for liposomed resveratrol and curcumin Dietary Supplement: Isocaloric Diet Drug: Dutasteride 0.5 mg Other: Placebo microcrystalline methylcellulose Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Intervention group: 50 patients will be administered daily the combination of Resveratrol (75mg) and Curcumin (200mg) liposomes with Dutasteride (0.5mg), in a single dose for 6 months.
  • Control group: 50 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 Dutasteride. Both the packaging and the capsule format will be identical to those of the treatment administered in the intervention group.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Impact of the Combined Treatment of Curcumin and Resveratrol Liposomed Polyphenols With Dutasteride on the Clinical Improvement of ALS Patients
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: Intervention group
50 patients will be given the combination of resveratrol and curcumin liposomed with dutasteride, in a single daily dose for 6 months.
Dietary Supplement: Liposomed polyphenols resveratrol and curcumin
Combination of resveratrol (75mg) and curcumin (200mg) liposomed

Dietary Supplement: Isocaloric Diet
40% carbohydrates, 40% lipids and 20% proteins

Drug: Dutasteride 0.5 mg
Dutasteride (0.5mg), in a single daily dose for 6 months
Other Name: Dutasteride

Placebo Comparator: Control group
50 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 Dutasteride. 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
Water with sucrose replacing the liposomed polyphenols

Dietary Supplement: Isocaloric Diet
40% carbohydrates, 40% lipids and 20% proteins

Other: Placebo microcrystalline methylcellulose
Placebo replacing dutasteride




Primary Outcome Measures :
  1. Revised Amyotrophic Lateral Sclerosis Functional Rating Scale associated with ALS [ Time Frame: Time 0 ]
    Maximum value: 48 points; Means better outcome motor variables Minimum value: 0 points

  2. Revised Amyotrophic Lateral Sclerosis Functional Rating Scale associated with ALS [ Time Frame: 3 months ]
    Maximum value: 48 points; Means better outcome motor variables Minimum value: 0 points

  3. Revised Amyotrophic Lateral Sclerosis Functional Rating Scale associated with ALS [ Time Frame: 6 months ]
    Maximum value: 48 points; Means better outcome motor variables Minimum value: 0 points

  4. Electromyography [ Time Frame: Time 0 ]
    Motor Variables

  5. Electromyography [ Time Frame: 3 months ]
    Motor Variables

  6. Electromyography [ Time Frame: 6 months ]
    Motor Variables

  7. Measurement of forced vital capacity [ Time Frame: Time 0 ]
    Motor Variables

  8. Measurement of forced vital capacity [ Time Frame: 3 months ]
    Motor Variables

  9. Measurement of forced vital capacity [ Time Frame: 6 months ]
    Motor Variables


Secondary Outcome Measures :
  1. Quantitative measurement of plasma IL-6 and TNF-alpha. [ Time Frame: Time 0 ]
    Variables related to inflammation and oxidation

  2. Quantitative measurement of plasma IL-6 and TNF-alpha. [ Time Frame: 3 months ]
    Variables related to inflammation and oxidation

  3. Quantitative measurement of plasma IL-6 and TNF-alpha. [ Time Frame: 6 months ]
    Variables related to inflammation and oxidation

  4. Quantitative measurement of plasma PCR. [ Time Frame: Time 0 ]
    Variables related to inflammation and oxidation

  5. Quantitative measurement of plasma PCR. [ Time Frame: 3 months ]
    Variables related to inflammation and oxidation

  6. Quantitative measurement of plasma PCR. [ Time Frame: 6 months ]
    Variables related to inflammation and oxidation

  7. Quantitative measurement of plasma haptoglobin. [ Time Frame: Time 0 ]
    Variables related to inflammation and oxidation

  8. Quantitative measurement of plasma haptoglobin. [ Time Frame: 3 months ]
    Variables related to inflammation and oxidation

  9. Quantitative measurement of plasma haptoglobin. [ Time Frame: 6 months ]
    Variables related to inflammation and oxidation

  10. Quantitative measurement of TEAC (oxidation). [ Time Frame: Time 0 ]
    Variables related to inflammation and oxidation

  11. Quantitative measurement of TEAC (oxidation). [ Time Frame: 3 months ]
    Variables related to inflammation and oxidation

  12. Quantitative measurement of TEAC (oxidation). [ Time Frame: 6 months ]
    Variables related to inflammation and oxidation

  13. Quantitative measurement of plasma 8-oxoG. [ Time Frame: Time 0 ]
    Variables related to inflammation and oxidation

  14. Quantitative measurement of plasma 8-oxoG. [ Time Frame: 3 months ]
    Variables related to inflammation and oxidation

  15. Quantitative measurement of plasma 8-oxoG. [ Time Frame: 6 months ]
    Variables related to inflammation and oxidation

  16. Quantitative measurement of plasma MDA. [ Time Frame: Time 0 ]
    Variables related to inflammation and oxidation

  17. Quantitative measurement of plasma MDA. [ Time Frame: 3 months ]
    Variables related to inflammation and oxidation

  18. Quantitative measurement of plasma MDA. [ Time Frame: 6 months ]
    Variables related to inflammation and oxidation

  19. Edinburgh Cognitive and Behavioral ALS Screen [ Time Frame: Time 0 ]

    Variable for cognitive and behavioural assesment

    Maximum value: 136 points; Means better outcome Minimum value: 0 points

    Includes a behavioural test to interview the care provider


  20. Edinburgh Cognitive and Behavioral ALS Screen [ Time Frame: 3 months ]

    Variable for cognitive and behavioural assesment

    Maximum value: 136 points; Means better outcome Minimum value: 0 points

    Includes a behavioural test to interview the care provider


  21. Edinburgh Cognitive and Behavioral ALS Screen [ Time Frame: 6 months ]

    Variable for cognitive and behavioural assesment

    Maximum value: 136 points; Means better outcome Minimum value: 0 points

    Includes a behavioural test to interview the care provider


  22. Frontal Assessment Battery [ Time Frame: Time 0 ]

    Variable for cognitive and behavioural assesment

    Maximum value: 18 points; Means better outcome 16-15 points means frontosubcortical deficit 13-12 points means frontosubcortical dementia Minimum value: 0 points

    Includes a behavioural test to interview the care provider


  23. Frontal Assessment Battery [ Time Frame: 3 months ]

    Variable for cognitive and behavioural assesment

    Maximum value: 18 points; Means better outcome 16-15 points means frontosubcortical deficit 13-12 points means frontosubcortical dementia Minimum value: 0 points

    Includes a behavioural test to interview the care provider


  24. Frontal Assessment Battery [ Time Frame: 6 months ]

    Variable for cognitive and behavioural assesment

    Maximum value: 18 points; Means better outcome 16-15 points means frontosubcortical deficit 13-12 points means frontosubcortical dementia Minimum value: 0 points

    Includes a behavioural test to interview the care provider



Other Outcome Measures:
  1. Variables related to the microbiota [ Time Frame: Time 0 ]
    A Clinical Intestinal Microbiome will be performed, which is an analysis of the bacterial microbiota present in the intestine, from a stool sample.

  2. Variables related to the microbiota [ Time Frame: 6 months ]
    A Clinical Intestinal Microbiome will be performed, which is an analysis of the bacterial microbiota present in the intestine, from a stool sample.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Women under 50 years of age and childbearing age.
  • Tracheotomy patients.
  • Patients with invasive or non-invasive ventilation with positive ventilatory pressure
  • Gastrectomized patients.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654689


Contacts
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Contact: José Enrique De la Rubia Ortí, Ph 669367704 joseenrique.delarubi@ucv.es

Locations
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Spain
José Enrique de la Rubia Ortí
Valencia, Spain, 46007
Sponsors and Collaborators
Fundación Universidad Católica de Valencia San Vicente Mártir
Investigators
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Principal Investigator: José Enrique De la Rubia Ortí, Ph Universidad Católica de Valencia
Publications:
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
Galvez, Jorge; Llompart, Javier; Pal, Kollol. N,N-dicyclohexyl-(1S)-isoborneol-10-sulfonamide (MT103) and related compounds for the treatment of cancer. US20040266732. 2004
Llompart, Javier; Galvez, Jorge; Pal, Kollol. Treatment of cancer with MT477 derivatives. US20060014770. 2006
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
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.
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
Wechsler D. WMS-R: Wechsler Memory Scale-Revised Manual. 1987. San Antonio: The Psychological Corporation

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Responsible Party: José Enrique de la Rubia Ortí, Director, Fundación Universidad Católica de Valencia San Vicente Mártir
ClinicalTrials.gov Identifier: NCT04654689    
Other Study ID Numbers: UCV/2020-2021/018
2020-005143-23 ( EudraCT Number )
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Variables related to inflammation and oxidation:

  • Quantitative measurement of plasma IL-6 and TNF-alpha.
  • Quantitative measurement of plasma PCR.
  • Quantitative measurement of plasma haptoglobin.
  • Quantitative measurement of TEAC (oxidation).
  • Quantitative measurement of plasma 8-oxoG.
  • Quantitative measurement of plasma MDA.

Variables for cognitive and behavioural assessment:

  • Edinburgh Cognitive and Behavioral ALS Screen
  • Frontal Assessment Battery (FAB)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Curcumin
Resveratrol
Dutasteride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Antioxidants
Protective Agents
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents