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Amyloidosis clinical trials

View clinical trials related to Amyloidosis.

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NCT ID: NCT03542656 Completed - Alzheimer Disease Clinical Trials

Application of Amyloid PET in Cerebral Amyloid Angiopathy

CAA
Start date: September 11, 2014
Phase: Phase 3
Study type: Interventional

In this project, we will try to enhance the diagnostic potentials of amyloid PET in CAA by combination of dynamic amyloid PET with MRI SWI and MR perfusion images. We will also try to investigate the roles of CAA in patients with drug-related ICH and validate the accuracy of clinical CAA diagnostic criteria. In addition, we will try to study the characteristics of long-term progression of amyloid deposition in CAA patients. This project will enroll 100 patients with ICH, 30 patients with AD, and 30 control subjects. Each patient will receive the above image studies, followed by data analysis and comparison.

NCT ID: NCT03527342 Enrolling by invitation - Clinical trials for Hypertrophic Cardiomyopathy

Sahlgrenska Cardiomyopathy Project

Start date: June 1, 2018
Phase:
Study type: Observational [Patient Registry]

This is a joint project by Sahlgrenska University Hospital: Sahlgrenska, Östra and Mölndal. Our objective is to diagnose and map patients with well phenotyped cardiomyopathies (CMP) including in depth clinical and molecular phenotyping to enable earlier and specific treatment. The project will serve as: 1. resource for diagnostic and therapeutic trials 2. common biomaterial bank 3. resource for detailed molecular analyses on patients' biomaterials and patient specific symptoms and examination results

NCT ID: NCT03499808 Active, not recruiting - Constipation Clinical Trials

S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

Start date: June 6, 2018
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.

NCT ID: NCT03481972 Completed - Clinical trials for TTR Cardiac Amyloidosis

A Study of Doxycycline and Tauroursodeoxycholic Acid (Doxy/TUDCA) Plus Standard Supportive Therapy Versus Standard Supportive Therapy Alone in Cardiac Amyloidosis Caused by Transthyretin

Start date: April 11, 2018
Phase: Phase 3
Study type: Interventional

Cardiac amyloidosis caused by transthyretin either mutated (in ATTRm amyloidosis) or wildtype (in ATTRwt, formerly senile, amyloidosis) is a rare disease but is diagnosed with increasing frequency thanks to the availability of non-invasive scintigraphy-based means. Cardiac ATTR amyloidosis is characterized by progressive heart failure with a median survival of less than 4 years, and there is no standard treatment for this disease. It was proved that the marketed antibiotic doxycycline (Doxy) disrupts amyloid fibrils in vitro and in animal models synergistically with tauroursodeoxycholic acid (TUDCA). Based on these pre-clinical data, a clinical trial of Doxy/TUDCA in ATTR Amyloidosis (NCT01171859) was conducted. Treatment was well tolerated and was able to prevent progression of cardiac dysfunction.

NCT ID: NCT03474458 Terminated - Clinical trials for Cardiac AL Amyloidosis

A Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based Therapy

Start date: February 11, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Systemic amyloidoses are rare diseases affecting approximately 1 in 100,000 persons each year. In systemic amyloidoses abnormal proteins deposit in bodily organs and severely impair their function, causing death if not treated effectively. Light chain (AL) amyloidosis is caused by a usually small population of plasma cells (the cells that produce antibodies). These cells produce part of antibodies, the light chains (LC) that form amyloid deposits. Almost every organ, with the exception of the brain, can be affected by AL amyloidosis. The heart is involved in three fourths of patients and is responsible for almost all the deaths occurring in the first 6 months after diagnosis. Current therapy of AL amyloidosis is based on drugs targeting the plasma cells producing the amyloid-forming LC. At present, most patients receive a powerful anti-plasma cell drug, bortezomib, as part of their initial treatment. However, bortezomib-based therapy, can improve heart involvement only in less than one third of patients with AL amyloidosis, and many patients (approximately one third) still die within 12 months from diagnosis. Early cardiac deaths remain an acute unmet need and the major determinant of overall outcome in this disease. Thus, there is the need of alternative means to treat heart involvement in AL amyloidosis. Doxycycline is a widely used, well tolerated, antibiotic that has been marketed for decades and used to treat a number of different infectious diseases caused by bacteria. This molecule has been extensively studied in the laboratory, in animal models and, more recently, in small studies involving patients, for its potential of improving cardiac damage in amyloidosis. These studies showed that doxycycline disrupts amyloid deposits, reduces the amyloid load in a mouse model, and counteracts the toxicity exerted by amyloid-forming LCs on C. elegans, a worm whose pharynx is used as a model resembling human heart. In a small clinical study, doxycycline was given to patients with cardiac AL amyloidosis during treatment for their underlying plasma cell disease. This resulted in a remarkable improvement of survival compared to "matched historical controls" (i.e. similar patients who had received only anti-plasma cell therapy without doxycycline in the past). Based on these promising preliminary results, we designed the present clinical trial to assess whether the addition of doxycycline to anti-plasma cell therapy can improve survival in patients with cardiac AL amyloidosis who were not previously treated. The rate of survival at 12 months will be compared in patients receiving doxycycline and in controls receiving standard antibiotic therapy, together with anti-plasma cell therapy. Patients will be assessed for parameters of plasma cell disease, heart involvement and possible involvement of other organs, as well as for quality of life. To make sure that patients who will receive doxycycline and those who will not have comparable severity of cardiac disease, patients will be stratified according to the stage of cardiac involvement. Patients with very advanced heart dysfunction will not be enrolled in the trial, because preliminary data indicate that doxycycline is of little or no benefit in these subjects. Patients will be randomized to receive doxycycline or standard antibiotics in combination with anti-plasma cell therapy. Bortezomib-based treatment directed against plasma cells will be delivered according to each participating institutions' guidelines. Doxycycline will be administered at a dosage of 100 mg two times a day, which is usual in the treatment of bacterial diseases. Standard antibiotics will be delivered according to each participating institutions' guidelines (provided that drugs of the same class as doxycycline are not administered) in the control arm. Patients will be provided a diary to record possible adverse events and will be instructed accordingly. Patients will be evaluated at trial centers every 2 months for treatment efficacy and toxicity. In case of unsatisfactory response second-line therapy will be initiated. In the absence of unacceptable toxicity, doxycycline administration will be continued for the entire duration of follow-up (12 months).

NCT ID: NCT03472482 Recruiting - Alzheimer Disease Clinical Trials

Optical Coherence Tomography in Cerebral Amyloidosis

Start date: March 25, 2016
Phase:
Study type: Observational [Patient Registry]

In this observational study, the investigators aim to evaluate whether changes in the retinal and choroidal circulation, as assessed by Optical Coherence Tomography (OCT) and the quantification of retinal amyloid deposits using auto-fluorescence and hyperspectral retinal imaging, are correlated with the degree and subtype of dementia and with the presence or absence of a positive amyloid scan. For this purpose, patients with established Alzheimer's Disease (AD) and Lewy Body Dementia (LBD), as well as amyloid positive and amyloid negative Mild Cognitive Impairment (MCI) and aged matched cognitively intact patients will be included in this cross-sectional study.

NCT ID: NCT03464344 Active, not recruiting - Clinical trials for Cerebral Amyloid Angiopathy

Cortical Superficial Siderosis and Risk of Recurrent Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.

CORELIA
Start date: October 12, 2018
Phase: N/A
Study type: Interventional

Cerebral amyloid angiopathy (CAA) is a major cause of lobar intracerebral hemorrhage (ICH) in the elderly with high risk of recurrence. The investigators aim to determine the relationship between cortical superficial siderosis (cSS), a MRI hemorrhagic marker of CAA and the risk of symptomatic ICH recurrence in a multicentric prospective cohort of patients with acute lobar ICH related to CAA. The investigators hypothesize that patients with cSS have an increased risk of recurrent symptomatic ICH relative to those without cSS.

NCT ID: NCT03431896 Active, not recruiting - Amyloidosis Clinical Trials

Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis

MED-hATTR
Start date: February 1, 2018
Phase:
Study type: Observational

This study measures circulating, misfolded ATTR oligomers in asymptomatic ATTRm amyloidosis genetic carriers longitudinally over five years.

NCT ID: NCT03417830 Terminated - Amyloidosis Clinical Trials

Biodistribution of 89Zirconium-labelled GSK2398852 Using PET Imaging

Start date: April 6, 2018
Phase: Phase 1
Study type: Interventional

The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.

NCT ID: NCT03414632 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

Transthyretin Cardiac Amyloidosis in HFpEF

Start date: December 1, 2017
Phase: Early Phase 1
Study type: Interventional

To estimate the prevalence of transthyretin cardiac amyloidosis (TTR-CA) among Heart Failure with Preserved Ejection Fraction (HFpEF) patients with increased LV wall thickness in Southeast Minnesota using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).