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A Clinical Study of Two Doses of a Selective p38 MAP Kinase Inhibitor, VX-745, to Evaluate the Effects of 12-Week Oral Twice-Daily Dosing on Amyloid Plaque Load as Assessed by Quantitative Dynamic 11C-PiB Positive Emission Tomography (PET) Amyloid Scanning

The primary objective is to assess the effects on amyloid plaque burden of administration of VX-745 for 12-weeks, as assessed by Dynamic 11C-PiB (Carbon-11 labeled Pittsburgh Compound B) PET Amyloid Scanning in patients with Mild Cogntitive…

An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome

PrimaryTo evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with FXS as assessed by:* Incidence and severity of adverse events and serious adverse events* Changes in vital signs, laboratory assessments, and ECGs*…

A Phase 2a, Proof-of-Concept, Open-Label Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Obicetrapib in Patients with Early Alzheimer*s Disease (Hetero/Homozygote APOE4 Carriers)

The primary objective of this study is to evaluate the pharmacodynamics (PD) (apolipoproteins/lipid particles and cholesterol efflux) of obicetrapib in cerebrospinal fluid (CSF) and plasma (apolipoproteins/lipid particles) in patients with early…

A 12-month, open-label, multicenter, randomized, safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional follow-up and a long-term extension (CONTRAIL I).

This study will allow the assessment of the ability of CFZ533 to replace calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing potentially better renal function with an expected similar safety and tolerability profile.…

A MULTICENTER, LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF AL002 IN PARTICIPANTS WITH ALZHEIMER*S DISEASE

This study has been transitioned to CTIS with ID 2023-506872-29-00 check the CTIS register for the current data. The primary objectives of this add-on Phase 2 LTE study (see Table 1) are to evaluate the long-term safety and tolerability of IMP at…

A Phase 2, Single-Arm Study of the Biomarker Effects of ALZ-801 in Subjects with Early Alzheimer*s Disease Who Are Carriers of the *4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4)

This study has been transitioned to CTIS with ID 2024-515858-25-00 check the CTIS register for the current data. Objectives - Core StudyPrimary Objectives• To evaluate the effects of oral ALZ-801 in subjects with Early AD who have the APOE4/4 or…

Bumetanide to Ameliorate Tuberous Sclerosis Complex Hyperexcitable Behaviors

Primary aim: to confirm that treatment with bumetanide improves daily life functioning and reduces behavioral symptoms related to hyperexcitability in children and adolescents with TSC.Secondary aim: to identify neurophysiological and cognitive…

A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Dementia with Lewy Bodies (DLB)

To assess the long-term safety and tolerability of 35 mg and 70 mg RVT-101 in subjects with DLB