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Amyloidosis clinical trials

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NCT ID: NCT04513600 Recruiting - Clinical trials for Transthyretin Amyloidosis

ATTR-Cardiomyopathy Stabilization Following Tafamidis Therapy

Start date: August 1, 2020
Phase:
Study type: Observational

The study will investigate the stabilization effects of Tafamidis utilizing cardiac imaging cardiac magnetic resonance imaging (CMR). The investigators propose to pursue the following specific aims: 1. Utilize cardiac magnetic resonance to assess stabilization of ATTR after Tafamidis therapy based on extracellular volume mapping. 2. Investigate left ventricular myocardial mass, native T1, T2, and extracellular volume mapping after 12 month follow-up. 3. Utilize cardiac magnetic resonance feature tracking at baseline and at 12 month follow-up.

NCT ID: NCT04468659 Recruiting - Clinical trials for Preclinical Alzheimer's Disease

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

Start date: July 14, 2020
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.

NCT ID: NCT04459169 Recruiting - Cardiac Amyloidosis Clinical Trials

Cardiac Amyloidosis : Diagnostic Using Red Flag Signals

TEAM Red Flags
Start date: September 30, 2020
Phase:
Study type: Observational

Cardiac amyloidosis is an increasingly contributor of degenerative cardiac diseases. However, its frequency remains underestimated, and diagnosis is often realized at late stages of the disease. A larger use of clinical and echographic Red Flag signals during routine echocardiographic examination may enhance the identification of early stage of the disease.

NCT ID: NCT04456582 Recruiting - Amyloidosis Clinical Trials

Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique (Bidimensional Shear Wave Elastography) in Patients With Transthyretin Amyloidosis

ELAST-2D
Start date: June 3, 2020
Phase: N/A
Study type: Interventional

Amyloidosis by mutation of the transthyretin gene (ATTRh) is part of a group of diseases in which the deposit of structurally abnormal proteins (amyloid fibrils) affects multiple organs such as: liver, kidney, eyes, nervous system, gastrointestinal tract and heart, and, finally, it increases the morbidity and mortality of affected patients. This deposit in the myocardium is manifested syndromically as heart failure with preserved or slightly reduced systolic function, and important diastolic dysfunction. The analysis of diastolic function comprises two components: the assessment of active relaxation, dependent on preload and afterload, and the assessment of the passive properties of the tissue - its hardness or rigidity. Myocardial stiffness represents an important parameter for diagnosis and prognosis, but its evaluation is not included in conventional echocardiography. Cardiac elastography has recently been proposed as a non-invasive diagnostic modality to assess myocardial stiffness.

NCT ID: NCT04392960 Recruiting - AL Amyloidosis Clinical Trials

Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis

Start date: July 22, 2020
Phase: N/A
Study type: Interventional

This will be a systematic, combined, prospective assessment of the novel echographic, CMR, and PET imaging tools in newly-diagnosed patients with cardiac AL amyloidosis at baseline and after treatment.

NCT ID: NCT04316442 Recruiting - Clinical trials for Light Chain (AL) Amyloidosis

Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis

Start date: April 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The STI-6129-001 study is a three-stage, multicenter, open-label, dose-finding, phase 1b/2a trial. It is designed primarily to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, preliminary efficacy and pharmacokinetics of this anti-CD38-Duostatin 5.2 antibody-drug conjugate (ADC) for the treatment of relapsed or refractory systemic AL amyloidosis. The patients that will be treated with STI-6129 in this trial are relapsed or refractory systemic AL amyloidosis patients who have received prior lines of treatment.

NCT ID: NCT04306510 Recruiting - Clinical trials for Hereditary Transthyretin Amyloidosis With Polyneuropthy

A Clinical Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Patients With hATTR-PN

Start date: January 21, 2021
Phase: Phase 4
Study type: Interventional

The objective of the study is to characterize adverse events (AEs) occurring within one day of TEGSEDI administration to adult patients with hATTR-PN overall and in individual patients with respect to time course of AE onset, vital sign changes, preventive measures, treatment required, risk factors, and subsequent adverse outcomes.

NCT ID: NCT04276220 Recruiting - Clinical trials for Transthyretin Amyloidosis

Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery

CACTuS2
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Patients above the age of 60 will be recruited at their carpal tunnel release surgery. Biopsies will be taken from the wrist and examined for the presence of amyloid protein. A amyloid-positive biopsy will refer the patients for cardiac examination including blod- and urine samples examined for transthyretin. If the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic TC99-DPD scintigraphy. If the scintigraphy is positive, the patient will be referred for right heart catherization (RHC) and an exercise test. Myocardial biopsies will be taken at the RHC and examined with electron microscopy and high resolution respirometry.

NCT ID: NCT04270175 Recruiting - AL Amyloidosis Clinical Trials

Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab

Start date: April 14, 2021
Phase: Phase 2
Study type: Interventional

This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical pomalidomide/dexamethasone treatment.

NCT ID: NCT04270058 Recruiting - Pregnancy Clinical Trials

TEGSEDI Pregnancy Surveillance Program

Start date: January 15, 2020
Phase:
Study type: Observational [Patient Registry]

This is a worldwide safety surveillance study of pregnancy outcomes in women with hATTR-PN who may have been exposed or were not exposed to TEGSEDI prior to or during the pregnancy and of pediatric outcomes up to 1 year of age.