Clinical trial NCT06019117: Effectiveness of Probiotic K10 in Managing Health Outcomes in Parkinson and Alzheimer Disease
Official title: Effectiveness of a Probiotic K10 in Managing Health Outcomes in Parkinson's Disease and in Early Stage (Mild Cognitive Impairment to Mild Dementia) and Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Alzheimer Disease
Keywords: Probiotic
Alzheimer
Parkinson
Neurological desease
Lead sponsor: Gon1 Gestao de Projetos
Sponsor class: NETWORK
First posted: 2023-08-31
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre, double-blind, placebo-controlled randomized clinical trial (RCT), Interventional Model: Parallel Assignment, phase III study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of the effects of the K10 probiotic mix in patients with degenerative neurological diseases (Parkinson and Alzheimer's) with a focus on cognitive, motor and psychiatric neurological evaluation.

Single-centre, double-blind, placebo-controlled randomized clinical trial (RCT), Interventional Model: Parallel Assignment, phase III study. Two groups will be composed, with two arms each, 1 group composed of patients with Parkinson's and 1 group with patients with Alzheimer's, 52 patients in each group. The first arm of each group will receive placebo and the other arm of each group will receive the mix K10.

In this study, researchers will conduct a randomized, placebo-controlled, phase III trial of a probiotic preparation (Probiotic K10) to evaluate its use as a viable treatment option for neurodegenerative disorders, including Parkinson's disease (PD) and Alzheimer's disease. of Alzheimer (AD). This formulation has been previously demonstrated to improve cognitive function, systemic inflammation, systemic oxidative stress in Alzheimer's patients. The main objective of this study is to compare its effect with placebo on cognitive status in individuals with AD and PD, the UPDRS total score in people with early PD and quality of life, and the measurement of caregiver burden in AD and PD. Participants will be randomly assigned to receive a placebo (an inactive substance) and a K10 probiotic (dose 2 ml/kg/day). They will be evaluated at baseline, 45 days and 90 days.

Detailed description: Change in urinary cortisol dosage Determination of cortisol levels can be used as an indirect measurement of emotional stress. Reduced levels of this hormone are related to reduced cardiovascular risk and reduced inflammatory damage.

Baseline to T90 or the time of sufficient disability to study closure.

All measurements will be taken at time zero (start of the survey), the next measurement in 45 days and the last measurement in 90 days. We will use the comparison of the data collected from each individual at time zero in comparison with their own results collected at the next times, using biostatistics to compare the results and, at the end of the primary result, we will perform the simple tabulation to count the values of each analyzed variable.

Differences between measures of central tendency with pr \< 0.05 will be considered statistically significant. When the central tendency values present a normal distribution in the statistical test, a parametric test will be used. In the case of comparison of 2 means, Student's t test will be used, for paired or independent samples. When the comparison includes more than 2 means, analysis of variance (ANOVA) will be used for 1 way (a single factor, e.g. treatment time) or 2 ways (two factors, for example treatment time and control group x treated group ).

After verifying a significant difference in ANOVA, a post hoc protected t-test will then be applied to detect at which points in the analysis there are pairs with significant differences. When the analysis of the distribution (frequency) of the data shows a distribution that is not compatible with the Gaussian distribution, a corresponding non-parametric test will be used. Contingency tables 2 x 2 will also be used for later calculation of risk factors and to determine the significance through the X2 test.

The software to be used will be Prism from Graphpad v. 9

Eligibility criteria: Inclusion Criteria:

Eligibility criteria for individuals with Parkinson's. Ages eligible to participate in the study: 18 years or older Accept healthy volunteers: No. Gender Eligibility for Study: All genders

Inclusion criteria:

* Presence of all 3 cardinal features of Parkinson's disease (tooth tremor, bradykinesia, and rigidity). Clinical signs must be asymmetrical.
* Diagnosis of Parkinson's disease within 5 years of the Screening Visit.
* Age 18 years or older.
* Women must not be of childbearing potential or must use an approved form of contraception during the trial period.

Eligibility Criteria for Individuals with Alzheimer's. Eligible ages to participate in the study: 60 -85 years Accept healthy volunteers: No. Gender Eligibility for Study: All genders

Inclusion criteria:

* Men or women between the ages of 60 and 85
* Diagnosis of probable Alzheimer's disease
* Portuguese-speaking, English-speaking; Spanish-speaking if the individual site allows
* Study partner or caregiver to ensure compliance
* Mini-Mental State Exam score at screening visit greater than 14
* Stable medical condition for 3 months prior to screening, with no significant abnormal liver, kidney, or blood studies.
* Able to take oral medications
* Modified Hachinski Ischemic Index less than or equal to 4
* CT or MRI from the onset of memory impairment, demonstrating the absence of a clinically significant focal lesion
* Physically acceptable for this study, as confirmed by medical history, physical examination, neurological examination, and clinical testing

Exclusion Criteria:

Parkinson's Exclusion Criteria:

* Parkinsonism due to drugs including neuroleptics, alpha-methyldopa, reserpine, metoclopramide, valproic acid.
* Use of antioxidants (such as selegiline, rasagiline, vitamins E and C), additional supplemental vitamins or minerals, regular use of neuroleptics, chloramphenicol, valproic acid, warfarin.
* Other parkinsonian disorders.
* Modified Hoehn and Yahr score of 3 or more on Screening Visit or Baseline Visit.
* UPDRS tremor score of 3 or greater at Screening Visit or Baseline Visit.
* History of symptomatic stroke.
* Sufficient deficiency to require changes in dopaminergic medication treatment during follow-up compared to baseline treatment schedule.
* Other severe and uncompensated illnesses, including severe psychiatric illnesses.
* Patients with active cardiovascular, restrictive peripheral vascular, or cerebrovascular disease in the past year.
* Unstable dose of active CNS therapies.
* Use of appetite suppressants within 60 days of the Baseline Visit.
* History of active epilepsy within the past 5 years.
* Participation in other drug studies or use of other investigational drugs within 30 days prior to the Screening Visit.
* History of electroconvulsive therapy.
* History of any brain surgery for Parkinson's disease.
* History of structural brain disease, such as previous trauma causing damage detected on a CT scan or MRI, hydrocephalus, or previous brain neoplasms.

Alzheimer's Exclusion Criteria:

* Significant neurological disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis, or seizure disorder
* Major depression treated in the past 12 months, major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse
* History of invasive cancer within the past two years (excluding non-melanoma skin cancer)
* Use of any investigational agents within 30 days prior to screening
* Major surgery within 8 weeks prior to the Baseline Visit
* Uncontrolled cardiac conditions or severe unstable medical illnesses
* Antiretroviral therapy for human immunodeficiency virus (HIV)
* Conditions that will contribute to oxidative stress: current cigarette or cigar smokers (within past month), diabetics on insulin or poorly controlled on oral hypoglycemics
* Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol.

Primary outcomes:
measure: Change in MDS-Unified (PD)
timeFrame: 1st, 45 and 90 days
measure: Change in quality of life scale (PD)
timeFrame: 1st, 45 and 90 days
measure: Changes in anxiety levels (PD&AD)
timeFrame: 1st, 45 and 90 days
measure: Changes in cognitive status measured by brief battery (AD)
timeFrame: 1st, 45 and 90 days
measure: Change in Quality of Life (QOL) (AD)
timeFrame: 1st, 45 and 90 days
Secondary outcomes:
measure: Change in cortisol dosage (Parkinson's and Alzheimer's group)
timeFrame: 1st, 45 and 90 days
Other outcomes:
Locations:
city: Vitória
country: Brazil
facility: Gon1 gestora de Projetos
state: ES
Study officials:
affiliation: Gon1 Gestora de Projetos
name: Alyne M Ton, post-doc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gon1 Gestora de Projetos
name: Sarha A L Queiroz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gon1 Gestora de Projetos
name: Deivis O Guimaraes, Mba
role: STUDY_DIRECTOR
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