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Evaluation of 18F-AV-1451 kinetic modeling in patients in Alzheimer's disease and healthy controls

The primary objectives of this study are:* To evaluate tracer kinetic models for the purpose of quantifying specific binding of 18F-AV-1451 in cross sectional and longitudinal applications; and* To evaluate simplified methods for quantification of…

Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (ornithine phenylacetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonemia with an Episode of Hepatic Encephalopathy (STOP-HE Study)

The primary objective of this study is the following:**To evaluate the efficacy of OCR-002 for treatment of an acute hepatic encephalopathyepisode in cirrhotic patients requiring hospitalization**To evaluate the safety and tolerability of OCR-002 in…

TIBOHCA: A phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) after out of hospital cardiac arrest

The primary objective of this study is to evaluate the short term safety and tolerability, and pharmacokinetic properties of 2-IB when administered to adult patients after OHCA. Secondary objectives include safety and efficacy parameters at 30 days…

Validating in vivo quantification of tau with [18F]AV-1451 PET

This protocol is a follow-up of a previously submitted protocol (Evaluation of [18F]AV-1451 kinetic modelling in patients with Alzheimer*s Disease and healthy controls, protocol nr. 2014.519), in which the optimal (simplified) kinetic model for [18F…

Tau Imaging in Tauopathies; Alzheimer's disease and Non-AD dementias

To 1) clinically validate the novel PET-tracer [18F]AV1451 for tau pathology as a diagnostic and prognostic marker in tauopathies, 2) to examine the (change in) (regional) binding of [18F]AV1451 across tauopathies, and the relationships between (…

Multicentre, Open-label, Randomised Study to Assess the Diagnostic Value of Amyloid PET
Imaging in Patients with Subjective Cognitive Decline Plus, Mild Cognitive Impairment, or Dementia
Where Alzheimer*s Disease Is in the Differential Diagnosis (Diagnostic and Patient Management
Study)

This study (AMYPAD Diagnostic and Patient Management Study) will determine in a real-life clinical setting for whom diagnostic amyloid PET imaging is appropriate, when this is best performed, and how the resulting information is influencing…

A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF BRIVARACETAM IN NEONATES WITH
REPEATED ELECTROENCEPHALOGRAPHIC SEIZURES

This study has the purpose to assess the pharmacokinetic (the science determining the fate of substances administered to the human body), safety and efficacy of brivaracetam (the study drug) in neonates who have seizures that are not adequately…

Spinal morphine in patients with hip fractures to reduce delirium

The main objective is to decrease the incidence of delirium in patients receiving surgical treatment of a proximal femur fracture with spinal anesthesia.

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-921352 as Adjunctive Therapy in Subjects with hSCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

Main objective: To assess the efficacy of NBI-921352 as adjunctive therapy on the frequency of countable motor seizuresSecondary Objectives • To evaluate the efficacy of NBI-921352 using the Clinical and Parent/Caregiver Global Impression of Change…