NCT05142085

Efficacy of Nano-PSO in Parkinson's Disease.

Status unknown NA Last updated 2 December 2021

What this trial tests

NA trial testing nano-PSO in Parkinson Disease in 170 participants. Status unknown.

Timeline

20 September 2021

Primary endpoint
3 January 2023

30 June 2023

Quick facts

Lead sponsor	Distribuidora Biolife SA de CV
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	170
Start date	20 September 2021
Primary completion	3 January 2023
Estimated completion	30 June 2023
Sites	1 location across Mexico

Drugs / interventions tested

• nano-PSO
• placebo

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Distribuidora Biolife SA de CV

Who can join

Adults 48 to 65, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. Decoding natural products for neuroprotection: Pathway networks and structural insights for drug development.
   Ghosh S, Debnath I, Bhunia S, Nandi S, et al · · 2025 · cited 4× · PMID 41399798 · DOI 10.1016/j.chmed.2025.09.005
2. Nanotechnology-driven therapies for neurodegenerative diseases: a comprehensive review.
   López-Espinosa J, Park P, Holcomb M, Godin B, et al · · 2024 · cited 3× · PMID 39297726 · DOI 10.1080/20415990.2024.2401307