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Neuroinflammatory Response clinical trials

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NCT ID: NCT06021262 Recruiting - Neurotoxicity Clinical Trials

Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity

Start date: August 2023
Phase:
Study type: Observational

The aim of this observational study is to answer the following questions in individuals with acute and chronic exposure to organophosphates. The main questions to be addressed are 1. What are the prognostic values of neuroinflammatory markers? 2. What are the genotoxic effects of organophosphates? 3. what are the changes occurring in the levels of traditional oxidative stress and inflammatory markers?

NCT ID: NCT05815225 Recruiting - Psychosis Clinical Trials

Neuroinflammation Markers in Subjects With Psychotic Symptoms

NEUROINPS17
Start date: November 1, 2017
Phase:
Study type: Observational

The main objective of the study is to measure the plasma and intracellular levels of several neuroinflammation markers (including cytokines and chemokines) and the endocannabinoid system in subjects presenting psychotic symptoms, initially recruited in a Mental Health Hospitalization Unit, and in different stages of their disease. To this end, we will evaluate and clinically characterize a cohort of patients who present active psychotic symptoms at the time of recruitment, and comparing it with a control group with similar sociodemographic characteristics. We will also compare our sample with a smaller sample previously recruited from patients with substance use and psychotic symptoms. Within our cohort of patients with psychotic symptomatology we will distinguish in turn affective psychoses from non-affective psychoses, on the one hand; and induced and non-induced psychosis by drug consumption, on the other. We will also classify patients based on whether they are experiencing the first episode of their illness or a relapse. This is an observational, longitudinal and prospective study. 3 blood draws will be performed from the subjects included in the study: the first, in the first 48 hours of hospital admission; the second, in the 48 hours prior to discharge; and the third, 6 months after discharge. The rater team will be composed of senior psychiatrists and training psychiatrists. The sample will be composed of subjects with psychotic symptoms who come from the Mental Health Clinical Management Unit of the Regional University Hospital of Malaga. Each patient enrolled in this study will undergo a clinical evaluation (psychiatric diagnostic interview and psychometric scales). From the plasma and white blood cells of the blood sample, the biochemical levels of the inflammatory mediators will be determined. Demographic, clinical, and biochemical data will be assessed and analysed using statistical programmes.

NCT ID: NCT05605366 Not yet recruiting - Clinical trials for Cognitive Impairment

Minocycline In Neurocognitive Outcomes - Sickle Cell Disease

MINO-SCD
Start date: June 1, 2024
Phase: Phase 1
Study type: Interventional

Sickle cell disease (SCD) is a common, inherited blood disorder that primarily affects people of African Ancestry. It has a lot of complications including neurological complications. The neurological complications of SCD are particularly devastating and lead to cognitive decline even in the absence of overt brain injury. In such cases, it is thought that inflammation in the brain maybe partly responsible for the cognitive decline. The main reasons for this research study are to see 1) how safe and 2) how well minocycline works to try to stop/reverse cognitive decline in people with SCD. People with SCD are at risk for changes in their brain over time that can cause problems with learning, memory, and attention. Part of the reason for this is inflammation within the brain. Minocycline may be able to stop these brain changes by stopping this brain inflammation. Minocycline is a second-generation tetracycline antibiotic that has been shown to both inhibit neuroinflammation and improve cognitive function in a variety of neurodegenerative and psychiatric disorders but has not yet been studied in SCD. We are proposing here, a pilot double-blinded, randomized controlled trial to examine the tolerability and early efficacy of minocycline in adults with SCD at two dosing regimens (200 mg and 300 mg daily) versus placebo over one year. Participants will undergo a neuropsychological exam using the NIH Toolbox Cognition Battery at both study enrollment and exit (after one year) to assess for changes/stability of cognition. Participants will receive monthly phone calls/text messages to assess for adverse events and will be seen every three months for pill counts and routine laboratory monitoring. The primary outcome will be a comparison of adverse events across the two dosing strategies versus placebo. Early evidence for cognitive benefit will also be assessed from the results of the NIH Toolbox.

NCT ID: NCT05570240 Completed - Knee Osteoarthritis Clinical Trials

The Relationship Between Chronic OA Pain and Cognition Deficits in OA Patients.

Start date: August 7, 2019
Phase:
Study type: Observational

The goal of this observational study is to learn about the association between pain characteristics and cognitive functions in chronic knee osteoarthritis. The main questions it aims to answer are: 1. If pain characteristics affect cognitive functions in severe knee OA patients? 2. If concentration of neuroinflammation mediators were raised in severe knee OA patients with comparing with control group participants? Participants will receive pain and cognition questionnaire before surgery and their blood and CSF will be collected for further analysis of neuroinflammation mediators.

NCT ID: NCT05514899 Recruiting - HIV Clinical Trials

Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV

CAMI
Start date: July 15, 2023
Phase: Phase 2
Study type: Interventional

This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation. Participants will be randomly assigned to one of two groups, both of which will receive the same treatment in a different order over a period of about 6 weeks. The visits include physical examinations, blood tests, and other procedures designed to monitor subject safety and measure the effects of the study drug.

NCT ID: NCT05429840 Completed - Clinical trials for Neuroinflammatory Response

Safety & PK of Single Doses of MT1980

Start date: June 1, 2022
Phase: Phase 1
Study type: Interventional

MT1980 is being developed as a treatment for neuroinflammation (an inflammatory response in the brain and/or spinal cord). Much research has focused on the central role of neuroinflammation in the pathogenesis of many conditions relating to the CNS, including eg, traumatic brain injury, stroke, Alzheimer's disease, post-operative cognitive decline (POCD)/perioperative neurocognitive disorder, and now even long-term cognitive side effects from severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Current anti-inflammatories do not easily cross the blood-brain barrier from the systemic circulation to the brain, making neuroinflammation a difficult condition to treat. This will be a Phase 1, single dose, randomized, placebo-controlled study in healthy subjects. The study will provide information on the safety of MT1980, the systemic bioavailability of the active drug, and levels of the active drug in the CSF. The study will be conducted in two parts. In Part 1, subjects will be randomized to receive a single oral dose of MT1980 or placebo in a parallel design. An interim PK and safety data analysis will be performed after Part 1 prior to dose selection in Part 2. In Part 2 subjects will be randomized to receive either placebo or a single oral dose of MT1980 at one of 2 strengths in a parallel design.

NCT ID: NCT05378659 Recruiting - Alzheimer Disease Clinical Trials

Neuroinflammation and Alzheimer's Pathology in POCD

POCD
Start date: November 1, 2021
Phase:
Study type: Observational

The purpose of this project is to investigate the role of both neural inflammation and pre-existing neurodegenerative pathology in the risk and pathogenesis of post-operative cognitive dysfunction (POCD). To achieve this goal, the investigators will combine blood and cerebrospinal fluid (CSF) sampling, standardized cognitive tests, and dynamic neurophysiological markers of cortical network dysfunction in the form of event-related potentials (ERPs), to assess the link between neurodegeneration and neuroinflammation in the pathogenesis of POCD.

NCT ID: NCT05008094 Enrolling by invitation - Parkinson Disease Clinical Trials

The Epidemiology of Parkinson's Disease in Croatia and the Influence of Genetic Factors and Microbiota on the Progression and Treatment Outcomes of the Disease (GiOPARK)

GiOPARK
Start date: May 1, 2020
Phase:
Study type: Observational

Parkinson's disease (PD) is the second most common neurodegenerative disease, which affects 2-3% of the general population above 65 years. There are significant differences in incidence depending on geographical location, race, and ethnicity. The exact cause of the disease is still unknown, but the role of genetic and environmental factors has already been established. Certain genetic forms of the disease make up for a small percentage, so it is thought that environmental factors have a more significant impact on the development of the disease. The incidence of PD is higher in people exposed to significant quantities of pesticides and traumatic brain injury, while there is a smaller incidence in smokers and people consuming more significant quantities of caffeine. The project will finish in four years, with the first 20 months dedicated to the first phase (genetic-epidemiological research), and the entirety of the 48 months for the second phase of the project (prospective clinical research). The main goal of the first phase of the project is to determine which genetic mutations are the ones most represented in the Croatian population afflicted with the familial form of PD. In the second phase the main goal is to determine the influence of genetic factors and microbiological factors on the disease's progression as well as on the treatment outcomes. Specific goals of this part of the project are to determine how many patients in the general population of PD patients present with a genetic disorder and which genes have a role in that disorder, as well as determine the composition of intestinal and oral microbiota both in the patient test group and the healthy control group. Furthermore, specific goals are to evaluate the effects of standard PD treatment on the composition of microbiota, neurodegeneration progression and the activity of neuroinflammation in the central nervous system (CNS) and to examine whether there is a link between the physiological and the pathophysiological function of microbiota, using markers of disease progression and glial activity. Last specific goal is to analyze potential pathological conformation protein forms that could be used as a biomarker in early stages of the disease and a biomarker of disease progression. The first phase of the study will provide the first epidemiologic data on the familial form of PD, as well as the mutations most represented in patients with PD in Croatia. Additionally, the prospective clinical study will contribute to enlightening the intertwined effects of genetic and environmental factors in the emergence and progression of the disease, as well as their effect on treatment outcome. Intestinal and oral microbiota composition analysis will determine whether there is a difference between PD and the healthy population while using the short-chain fatty acid profile will determine the metabolic differences between the two groups. Analyzing the markers of CNS homeostasis, inflammation, and neuroglial function will determine the progression of the disease and also correlate them to genetic factors as well as the microbiota function and composition. Analyzing the pathological conformation forms of alpha-synuclein could lead to the discovery of novel biomarkers in the early stages of the disease, as well as to follow the progression of the disease

NCT ID: NCT04662827 Completed - Pain, Acute Clinical Trials

The Effect of Palmitylethanolamide on Central and Peripheral Sensitization After Heat-induced Hyperalgesia

Start date: February 9, 2020
Phase: N/A
Study type: Interventional

This planned study is based on a randomized, placebo-controlled cross-over design. Palmityhlethanolamide (PEA) is an endogenous fatty acid amide from the group of N-Acetylethanolamides, which analgesic, anti-inflammatory and neuroprotective effects can be attributed to this. In clinical studies, PEA has mainly been used as an adjuvant in pain therapy. The previous data show clinical efficacy without conclusions that can be drawn about the underlying mechanisms - these have not yet been investigated in a human experiment. The planned study, which demonstrates the mode of action of PEA using an established pain model on healthy volunteers, will help to assign the efficacy to peripheral or central nervous systems. These mechanisms allow to establish mechanism-oriented therapy approaches. These findings are essential for a better understanding of the clinical efficacy and to evaluate the correct fields of application.

NCT ID: NCT04636723 Completed - Cancer Clinical Trials

Neuroinflammation in Chronic Systemic Symptoms (CSS)

Start date: February 22, 2021
Phase:
Study type: Observational

The purpose of the present research protocol is to investigate and identify translocator protein 18kDa, MRI DTI, and EEG/ERPs, markers of Chronic Systemic Symptoms (CSS).