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Brain Diseases clinical trials

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NCT ID: NCT05921929 Withdrawn - Clinical trials for Major Depressive Disorder

First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)

Start date: May 2, 2024
Phase: Phase 1
Study type: Interventional

The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are: - What is the safety of single ascending doses of the FluoroEthylNorMemantine (FENM)? - What is the PK profile of single ascending doses of the FENM in human? - What is the preliminary exploratory time course of Brain Disease Neurotrophic Factor (BDNF) plasmatic levels of single ascending doses of the FENM? Participants will receive one single oral dose of FENM.

NCT ID: NCT05581927 Withdrawn - Brain Injury Clinical Trials

Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood. Infants with moderate encephalopathy have a 10 percent risk of death, and those who survive have a 30 percent risk of disabilities. Sixty percent of infants with severe encephalopathy die, and many, if not all, survivors are disabled. Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.

NCT ID: NCT05321498 Withdrawn - Alzheimer Disease Clinical Trials

Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation

Start date: June 2023
Phase: Phase 2
Study type: Interventional

The goal of this Phase 2 MCI study is to determine whether 1.0 mg/kg XPro1595 is superior to placebo at improving measures of cognition, functioning and brain quality in individuals with MCI and biomarkers associated with neuroinflammation (APOE4) and to evaluate safety, tolerability, and efficacy of XPro1595.

NCT ID: NCT05295784 Withdrawn - Acute Kidney Injury Clinical Trials

PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia

Start date: May 8, 2024
Phase: Phase 1
Study type: Interventional

A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia. This study is an essential first step to develop caffeine as a kidney protective medication in this in this vulnerable group of newborns.

NCT ID: NCT05189834 Withdrawn - Clinical trials for Covert Hepatic Encephalopathy

GELSECTAN® and Covert Hepatic Encephalopathy

GELSECTAN
Start date: March 11, 2022
Phase: N/A
Study type: Interventional

Randomized crossover pilot clinical trial in which 10 cirrhotic patients with covert hepatic encephalopathy (CHE) will be assigned to take GELSECTAN® (TID) or placebo for 30 days. After a washout period of 15 days, the treatment branches will be interchanged. The objective of the trial is to obtain pilot variances to design a phase II trial, in which the efficacy of the treatment will be tested. As an exploratory objective, the efficacy of the product in the treatment of covert hepatic encephalopathy will be analyzed. Main endpoint Improvement in CHE after 30 days of treatment with GELSECTAN®, measured by the Psychometric hepatic encephalopathy score (PHES)

NCT ID: NCT04664621 Withdrawn - Cirrhosis, Liver Clinical Trials

HepQuant to Predict Hepatic Encephalopathy After TIPS

Start date: February 25, 2020
Phase: N/A
Study type: Interventional

A pilot study to determine if a simple blood test can predict patients at risk for significant episodes of confusion and disorientation that can occur in patients who receive an artificial shunt through the liver to control complications of liver disease.

NCT ID: NCT04311281 Withdrawn - Clinical trials for Suspected Chronic Traumatic Encephalopathy (CTE) or Traumatic Encephalopathy Syndrome (TES)

FDDNP Protocol for Visualizing Brain Proteinopathies to Assist in the Diagnosis of Persons With Suspected CTE and AD

FDDNP
Start date: May 2021
Phase:
Study type: Observational

The primary objective of this study is to demonstrate the safety and efficacy of positron emission tomography (PET) imaging with a radioactive compound called [F-18]FDDNP in subjects with suspected Alzheimer's disease or suspected chronic traumatic encephalopathy (CTE) to predict clinical decline after one and two years.

NCT ID: NCT04244877 Withdrawn - Cirrhosis, Liver Clinical Trials

Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility

Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

Small Intestinal Bacterial Overgrowth (SIBO) is a common and increasingly recognized disorder in cirrhosis (30% to 73%). One of the most important predisposing factors of SIBO is small bowel dysmotility. Multiple studies have shown that the presence of SIBO is strongly linked to the pathogenesis of Minimal Hepatic Encephalopathy (MHE) also known as Covert Hepatic Encephalopathy (CHE). Consequently, altering and modulating the intestinal microbiota with ammonia-lowering agents and Rifaximin has been the target treatment strategy in CHE. The aim of this study is to determine the therapeutic effect of Rifaximin on patients with CHE and underlying SIBO while assessing the influence of Rifaximin on small bowel motility. In this prospective interventional study, 40 patients with liver cirrhosis will be screened for Covert Hepatic Encephalopathy (CHE) using neuro-psychometric tests. Patients diagnosed with CHE will undergo breath test (BT) for SIBO screening. Afterwards, wireless motility capsule (The SmartPill) will be performed in all patients with a positive BT. Thereafter, the cirrhotic patients diagnosed with CHE and SIBO will receive Rifaximin 550 mg PO twice daily for eight weeks. At the end of treatment, neuro-psychometric tests will be repeated to evaluate the therapeutic effect on CHE. In addition, BT and SmartPill will be repeated at the completion of the Rifaximin treatment period to assess the effect on small bowel motility. All collected clinical parameters at the end of the study will be compared to baseline values.

NCT ID: NCT04128462 Withdrawn - Clinical trials for Hepatic Encephalopathy

MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function

Start date: November 2021
Phase: Phase 3
Study type: Interventional

This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function. All patients will receive the standard of (regular) care. Each will have an equal chance (like flipping a coin) of receiving the experimental drug or placebo along with the standard care. Each patient will have tests during the first 24 hours, receive treatment for up to 5 days, and have 30 days of follow-up.

NCT ID: NCT04118491 Withdrawn - Clinical trials for Carbon Monoxide Poisoning

Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy

HACMICE
Start date: July 2020
Phase: N/A
Study type: Interventional

In some patients, a few days or weeks after recovery from carbon monoxide poisoning, new symptoms develop. These can affect mood, ability to think or remember clearly, and movements. Some people develop movement problems that are similar to Parkinson's disease. This damage to brain tissue is called "encephalopathy," and this study will look at the effect of pressurized oxygen therapy on long term, or chronic, encephalopathy.