Amyloidosis Clinical Trials

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Early diagnosis of transthyretin cardiac amyloidosis

Disease modifying therapies for ATTR transthyretin cardiac amyloidosis (ATTR-CA) promises to make a previously untreatable disease manageable. In general, cardiac amyloidosis of any type has been shown to be underdiagnosed or diagnosed late in the disease process.

UPCC 25417: A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis

Request for collaborative review: Sterling IRB serving as IRB of record.

APOLLO-B: A Phase 3 Randomized Double-blind Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)

TBD

Phase II Study to Assess the Safety Tolerability and Target Engagement of AMX0035 a Fixed Combination of Sodium Phenylbutyrate and Tauroursodeoxycholic Acid for the Treatment of Alzheimers Disease

The trial will enroll subjects who are between 55 and 89 inclusive and must have a diagnosis of "Probable Alzheimer's Disease" or Mild Cognitive Impairment with a primarily amnestic presentation (deficit in learning and recall of recently learned information) that is accompanied by the presence of documented biomarkers (amyloid PET, …

Dose Escalation Study of Intravenous PRX004 in Subjects with Amyloid Transthyretin (ATTR) Amyloidosis

ATTR amyloidosis can run in families and this is known as hereditary ATTR amyloidosis. Hereditary ATTR amyloidosis usually affects the nerves or the heart, or both.

Molecular Imaging of the Underlying Mechanism of Cardiotoxicity in Patients with Light Chain Amyloidosis using Positron Emission Tomography (PET/CT)

In the other cohort PET/CT imaging will be used to measure amyloid deposition as an estimate of the actual AL load in the heart using an approved radiotracer called [18F]Florbetaben. Subjects in both cohorts will have two PET/CT scans performed, before therapy and 3-6 months after initiation of therapy.

18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimers Disease

BAN2401-G000-301 (Study 301) is an 18-month treatment (Core Study), multicenter, double-blind, placebo-controlled, parallel-group study in subjects with EAD (mild cognitive impairment [MCI] due to AD with intermediate likelihood/Prodromal AD or mild AD dementia) with confirmed amyloid pathology indicated by either positive amyloid load confirmed by amyloid PET assessment or CSF …

Four-Repeat Tauopathy Neuroimaging Initiative

While tau-related therapies hold great promise for AD, clinical trials focusing on pure tauopathies are appealing because these diseases do not exhibit concurrent amyloid pathology. Pure 4 microtubule binding repeat (4R) tauopathies (4RT) include corticobasal degeneration (CBD), progressive supranuclear palsy (PSP) and some variants of frontotemporal lobar degeneration.