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A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.

The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in patients with the following criteria: mild…

Symptomatic treatment of vascular cognitive impairment

Primary Objective: To study the change on performance on executive function and memory function (as measured on Neurocart), after an active challenge with methylphenidate (monoaminergic) and galantamine (cholinergic), compared to placebo, in…

A Randomized, Two-Period, Double-Blind Placebo-Controlled and Open-Label, Multicenter Extension Study to Determine the Long-Term Safety and Tolerability of JNJ-54861911 in Subjects in the Early Alzheimer*s Disease Spectrum

The primary objective of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in subjects in the early AD spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ 54861911 (e.g., Study 54861911ALZ2002),…

A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects in the Early (Predementia) Alzheimer*s Disease Spectrum

This safety study in subjects in the early (predementia) AD spectrum is performed to investigate primarily the safety and tolerability of JNJ-54861911 during 6 months of treatment.

The Effect of a Nutritional Intervention on brain Glucose Metabolism in early Alzheimer*s disease

To provide further insight into Souvenaid*s hypothesised mode of action, the current NL-ENIGMA study explores brain glucose metabolism in mild cognitive impairment (MCI) and mild dementia due to AD, using Positron Emission Tomography with 18F-FDG-…

A Magnetic Resonance Spectroscopy (MRS) study to explore the effects of a medical food on brain metabolites in patients with mild Alzheimer's Disease dementia(AD)

To explore the effects of the test product compared to the control product on brain phospholipid metabolism in mild AD patients using 31P-MRS. To explore the effects of the test product compared to the control product on the level of brain…

A 90-week, multi-center, randomized, double-blind, placebo-controlled study in patients with mild Alzheimer*s Disease (AD) to investigate the safety, tolerability and Abeta-specific antibody response following repeated i.m. injections of adjuvanted CAD106

The purpose of this study is to evaluate the benefit of adding an adjuvant to CAD106 and to select the dose of CAD106 and adjuvant to be used in further development. Additionally, clinical and biomarker measures (CSF, plasma biomarkers, volumetric…

A multicenter, randomized, double-blind, placebo-controlled, cross-over, proof of concept study comparing the effects of both single dose and repeated dosing treatment for 2 weeks of test compound in patients with chronic subjective tinnitus

To examine the multiple dose effects of the study medication test compound in tinnitus after a 2-week treatment.

*A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI) with a Lead-in, Open-Label, Single-Dose Relative Bioavailability Study of LX6171 Oral Suspension in Healthy Elderly Subjects*

Stage AThe primary objective is:• To compare the relative bioavailability of a single dose of 300 mg LX6171 using a 40mg/mL and an 80mg/mL formulated suspension;• To evaluate plasma concentrations of LX6171 and its major metabolite LP-523122 after a…

A multi-centre, double-blind, parallel-group, randomized controlled study to investigate the efficacy, safety and tolerability of orally administred BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer's disease.

The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in male and female patients at least 55 years of…

Randomized, double-blind, placebo controlled, multi-centre superiority phase II study to evaluate the safety, pharmacokinetic, efficacy of gabapentin liquid formulation as add-on to morphine in children from 3 months to less than 18 years of age experiencing severe chronic neuropathic or mixed pain.

The primary objective of this study is to assess the efficacy of gabapentin as add-on to morphine for the treatment of severe chronic neuropathic or mixed pain in children from 3 months to less than 18 years of age. Secondary objectives 1. To assess…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-on Therapy to Anti-Inflammatory Disease-Modifying Therapies

Part 1: To evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks.Part 2: evaluate long-term safety profile of BIIB033 as an add-on therapy in subjects with MS.

An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients

The objectives of this study are to:• Assess safety and tolerability of imlifidase in combination with standard IVIg treatment in GBS subjects• Evaluate pharmacokinetics of imlifidase• Evaluate pharmacodynamics profile of imlifidase• Evaluate…

A Phase IIb open-label, multi-centre, extension study to explore the long-term safety and efficacy of KH176 in subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation who have completed the KHENERGYZE study KH176-202.

The primary objective of this study is to enable continued treatment with the study drug sonlicromanol for patients who have completed study KH176-202 and to investigate the safety and tolerability of sonlicromanol over an 12 months treatment period…

A Randomized, Double-blind, Placebo-controlled, Parallel-group,
Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an
Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer's
Disease

This study has been transitioned to CTIS with ID 2022-501188-42-00 check the CTIS register for the current data. This Phase 2 study for JNJ-63733657 will assess the possible slowing of cognitive decline seen inprodromal AD and mild AD dementia (…

A DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 24 WEEKS TREATMENT WITH REN001 IN PATIENTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)

Main Objective:To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by the effect on exercise endurance.Secondary Objective:To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by…

A Phase IIb double-blind, randomised, placebo-controlled, multi-centre, confirmative three-way cross-over study on cognitive function with two doses of KH176 in subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation.

To evaluate the effect of KH176 during a 4 week treatment period on the attention domain score of cognitive functioning, as assessed by the visual identification test of the Cogstate computerised cognitive testing battery.

An open-label, multicenter, extension study to evaluate the safety and efficacy of padsevonil as adjunctive treatment of focal-onset seizures in adult subjects with drug resistant epilepsy

Objectives:Primary objectiveTo evaluate the long-term safety and tolerability of padsevonil (PSL) administered at individualized doses between 100 mg/day and 800 mg/day as adjunctive treatment for subjects with focal-onset seizures and drug-…

[18F]MC225-PET: Assessment of the blood-brain barrier integrity and P-glycoprotein function in healthy volunteers,a pilot study

Translation of [18F]-MC22518 to the clinic to measure P-gp function in healthy volunteers.

A study to investigate the effects of repeated low doses of psilocybin and ketamine on cognitive and emotional dysfunctions in Parkinson*s disease and to understand its mechanism of action

The primary objective is to investigate the effects of repeated small doses of psilocybin and ketamine on affect (self-rated). Secondary objectives are to is to investigate the effects of repeated small doses of psilocybin and ketamine on [1] well-…