Efficacy of Nano-PSO in Parkinson's Disease.

NCT05142085 | Unknown

• 1 other identifier: INNN0121
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The present research aims to carry out a double-blind, placebo-controlled clinical trial to study the efficacy of a new antioxidant. The primary outcome variables will be the changes observed in PD-motor and non-motor symptoms scales, as well as quality of life during a 6-months period. Global impression on the treatment will be rated after this period. Likewise, presynaptic changes will be studied in positron emission tomography studies, using 2 radiotracers and a dynamic image processing in patients with Parkinson's disease. 125 patients who have a definite diagnosis of PD will be included; 25 of them will be subjected to a triple-blind, clinical and molecular study. In addition, 25 other subjects from the same Institution and from 4 other collaborating centers will be part of the clinical arm of this study during the period September 2021- September 2022. During the first visit, various clinical data of the participants will be recorded such as: age, gender, family history, current medical conditions, and drugs dosage in addition to a comprehensive neurological examination. Subsequently, the signing of the informed consent will be obtained, and general laboratory tests and a brain RMI in 3dT1 and SWI sequences will be performed. A series of disease-specific scales will be applied in order to assess motor functional capacity, cognition, sleep, and other non-motor symptoms before drug delivery. Randomization will be made in blocks of 5 treatments: 3 nano-PSO and 2 placebos. Treatments will be delivered in form of bottles containing 100 capsules each after baseline and intermediate visit. 25 patients will also give their consent to perform 2 PET studies (positron emission tomography) to assess presynaptic dopaminergic function. This implies conducting these studies on 2 occasions (at the beginning and at the end of treatment), with emphasis on striatal activity to study the effect of treatment with Nano-PSO.

Conditions

Parkinson Disease

Keywords

Parkinson´s disease; punicic acid; neuroprotection; molecular imaging

Outcome Measures

Primary Outcomes (2)

• Changes in MDS-UPDRS motor scale

  The Unified PD rating scale (UPDRS) reviewed by the Movement Disorders Society is a 4 domains instrument that measures 1.- non-motor aspects of experiences of daily living ( 13 items),2.- Daily life activities (13 items). 3.- Motor examination (33 items) 4.- motor complications (6 items) Each item is scored from 0 to 4 , with the highest being the worst.

  6 months

• Changes in NMSS ( non-motor symptoms scale)

  This is a scale of 8 domains (cardiovascular, sleep/fatigue, mood/cognition, vision/hallucinations atention, gastrointestinal, urinary, sexual and others. where the presence, severity and frequency are multiplied, obtaining 0 for the best score, and 360 points for the worst case.

  6 months

Secondary Outcomes (3)

• Changes in PDQ-8

  6 months

• Modification of LEDD ( levodopa equivalent daily dose.)

  6 months

• Global impression of the treatment

  ...after 6 months

Study Arms (2)

Efficacy of nano-PSO on motor and non-motors symptoms of Parkinson´s disease.

EXPERIMENTAL

It is the clinical trial itself where more than 140 subjects will be included: 84 under active treatment and 56 under placebo

Dietary Supplement: nano-PSO; Other: placebo

Effect of nano-PSO on molecular images of PD patients

EXPERIMENTAL

In this group, the study implicates performing a multitracer PET-scan before treatment, and at 6 months, to 25 subjects in the clinical trial : 15 under active treatment and 10 in the placebo group.

Dietary Supplement: nano-PSO; Other: placebo

Interventions

nano-PSO DIETARY_SUPPLEMENT

This active treatment will be delivered to 3 out of 5 patients

Also known as: nanodroplet formulation of pomegranate seed oil (PSO)

Effect of nano-PSO on molecular images of PD patients; Efficacy of nano-PSO on motor and non-motors symptoms of Parkinson´s disease.

placebo OTHER

This treatment will be assigned to 2 out of 5 patients

Also known as: capsules of neutral mineral oil

Effect of nano-PSO on molecular images of PD patients; Efficacy of nano-PSO on motor and non-motors symptoms of Parkinson´s disease.

Eligibility Criteria

• Age: 48 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with Parkinson's disease confirmed with UKPDSBB and MDS clinical criteria.
• who signed the informed consent to follow the study protocol.
• Age at onset of PD: 45-60 years.
• Age at enrollment: 45-65 years
• Disease of 2 to 8 years of evolution
• Without uncontrolled chronic degenerative disease (High blood pressure, AF, dyslipidemia).
• Without uncontrolled diabetes mellitus
• With a fixed treatment during the last 3 months and throughout the study.
• A patient who does not suffer from another neurodegenerative disease.
• No symptomatic brain injury.
• A patient who can lie on his back for at least 2 hours in the OFF state of levodopa.

You may not qualify if:

• Patients unable to give their informed consent
• Subjects who are not able to fill out a questionnaire or cooperate during the study
• Diabetic people
• or with another uncontrolled chronic disease
• or with brain injury.

Sponsors & Collaborators

• Distribuidora Biolife SA de CV: lead

Study Sites (1)

Instituto Nacional de Neurología y Neurocirugía

Mexico City, Mexico City, 14269, Mexico

Location

Related Publications (12)

• Chondrogiannis S, Marzola MC, Al-Nahhas A, Venkatanarayana TD, Mazza A, Opocher G, Rubello D. Normal biodistribution pattern and physiologic variants of 18F-DOPA PET imaging. Nucl Med Commun. 2013 Dec;34(12):1141-9. doi: 10.1097/MNM.0000000000000008.

  PMID: 24128899 BACKGROUND

• Kumakura Y, Gjedde A, Danielsen EH, Christensen S, Cumming P. Dopamine storage capacity in caudate and putamen of patients with early Parkinson's disease: correlation with asymmetry of motor symptoms. J Cereb Blood Flow Metab. 2006 Mar;26(3):358-70. doi: 10.1038/sj.jcbfm.9600202.

  PMID: 16079784 BACKGROUND

• Nanni C, Fanti S, Rubello D. 18F-DOPA PET and PET/CT. J Nucl Med. 2007 Oct;48(10):1577-9. doi: 10.2967/jnumed.107.041947. No abstract available.

  PMID: 17909255 BACKGROUND

• Binyamin O, Larush L, Frid K, Keller G, Friedman-Levi Y, Ovadia H, Abramsky O, Magdassi S, Gabizon R. Treatment of a multiple sclerosis animal model by a novel nanodrop formulation of a natural antioxidant. Int J Nanomedicine. 2015 Nov 20;10:7165-74. doi: 10.2147/IJN.S92704. eCollection 2015.

  PMID: 26648720 BACKGROUND

• Binyamin O, Nitzan K, Frid K, Ungar Y, Rosenmann H, Gabizon R. Brain targeting of 9c,11t-Conjugated Linoleic Acid, a natural calpain inhibitor, preserves memory and reduces Abeta and P25 accumulation in 5XFAD mice. Sci Rep. 2019 Dec 5;9(1):18437. doi: 10.1038/s41598-019-54971-9.

  PMID: 31804596 BACKGROUND

• Binyamin O, Keller G, Frid K, Larush L, Magdassi S, Gabizon R. Continues administration of Nano-PSO significantly increased survival of genetic CJD mice. Neurobiol Dis. 2017 Dec;108:140-147. doi: 10.1016/j.nbd.2017.08.012. Epub 2017 Aug 25.

  PMID: 28847567 BACKGROUND

• Keller G, Binyamin O, Frid K, Saada A, Gabizon R. Mitochondrial dysfunction in preclinical genetic prion disease: A target for preventive treatment? Neurobiol Dis. 2019 Apr;124:57-66. doi: 10.1016/j.nbd.2018.11.003. Epub 2018 Nov 10.

  PMID: 30423473 BACKGROUND

• Zamora-Lopez K, Noriega LG, Estanes-Hernandez A, Escalona-Nandez I, Tobon-Cornejo S, Tovar AR, Barbero-Becerra V, Perez-Monter C. Punica granatum L.-derived omega-5 nanoemulsion improves hepatic steatosis in mice fed a high fat diet by increasing fatty acid utilization in hepatocytes. Sci Rep. 2020 Sep 17;10(1):15229. doi: 10.1038/s41598-020-71878-y.

  PMID: 32943651 BACKGROUND

• Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.

  PMID: 26474316 BACKGROUND

• Eidelberg D, Moeller JR, Dhawan V, Sidtis JJ, Ginos JZ, Strother SC, Cedarbaum J, Greene P, Fahn S, Rottenberg DA. The metabolic anatomy of Parkinson's disease: complementary [18F]fluorodeoxyglucose and [18F]fluorodopa positron emission tomographic studies. Mov Disord. 1990;5(3):203-13. doi: 10.1002/mds.870050304.

  PMID: 2117706 BACKGROUND

• Eshuis SA, Maguire RP, Leenders KL, Jonkman S, Jager PL. Comparison of FP-CIT SPECT with F-DOPA PET in patients with de novo and advanced Parkinson's disease. Eur J Nucl Med Mol Imaging. 2006 Feb;33(2):200-9. doi: 10.1007/s00259-005-1904-y. Epub 2005 Oct 15.

  PMID: 16228235 BACKGROUND

• Pysz MA, Gambhir SS, Willmann JK. Molecular imaging: current status and emerging strategies. Clin Radiol. 2010 Jul;65(7):500-16. doi: 10.1016/j.crad.2010.03.011.

  PMID: 20541650 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Nano-PSO

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Nora Kerik Rotenberg, MD

  INNN-MVS Department of Nuclear Medicine

  STUDY CHAIR

• Marie-Catherine Boll, MD,PhD

  Clinical Research Laboratory Instituto Nacional de Neurología y Neurocirugía MVS. MEXICO CITY

  PRINCIPAL INVESTIGATOR

• Ulises Rodríguez Ortiz, MDS

  Médica Sur Mexico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treatments are made in an independent laboratory that has a white area for packaging the placebos and the treatments with a label that is kept in a database on this site and, in its printed version, in another center. Boxes are prepared with a content of 5 treatments (2 placebos for 3 active ingredients)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Model Details: Double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 2, 2021
• Study Start: September 20, 2021
• Primary Completion: January 3, 2023
• Study Completion: June 30, 2023
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)