Safety and Effect of Doxycycline in Patients With Amyloidosis
Completed · Phase 2
Conditions studied: Amyloidosis
In brief
The tetracycline antibiotic doxycycline disrupts A beta amyloid fibrils (AB) in Alzheimer's disease, transthyretin (ATTR) amyloid fibrils in familial amyloidotic polyneuropathy, and immunoglobulin light chain (AL) amyloid fibrils in transgenic mouse models of disease. If untreated, amyloid deposits impair organ function, affecting the morbidity and mortality of patients. This single-center, twelve-month, open-label, prospective, pilot phase II study aims to determine whether doxycycline reduces amyloid deposits and improves organ function in patients with systemic or localized amyloidosis. The investigators plan to enroll patients with measurable amyloid disease according to internationally-accepted diagnostic criteria. Patients must have stable organ function at enrollment. Eligible subjects not receiving active treatments for amyloidosis affecting their kidneys, heart, aerodigestive tracts, peripheral or autonomic nervous system(s), lungs, eyes, skin, bladder, or breasts will undergo evaluations at baseline, 6 months, and 12 months - or more frequently as clinically indicated. Over 45 years experience indicates doxycycline is a safe, well tolerated antibiotic. The investigators will use standard grading systems to assess doxycycline response following twelve months of treatment.
Key facts
- Study ID
- NCT01677286
- Run by
- Boston University
- People needed
- 25
- Starts
- 2012-07-01
- Expected to finish
- 2015-12-15
- Last updated by the study team
- 2017-08-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 or older
- Biopsy-proven amyloidosis
- Biochemical or clinical evidence of amyloid induced end-organ dysfunction
You may not qualify if…
- Concurrent use of other tetracyclines
- Ongoing active treatment for amyloidosis
- Pregnancy or unwillingness to use contraception by women of childbearing age
- Doxycycline drug allergy/hypersensitivity
- ECOG performance status > 3
- NYHA class > 3
- Renal insufficiency (estimated creatinine clearance < 25 ml/min)
- Transaminitis (AST or ALT > 5 times upper limit of normal)
- Diabetes mellitus or hemoglobin A1C > 6.2%
Where it is running
- Boston University — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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