Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01677286 · ClinicalTrials.gov registry record · Phase 2
Safety and Effect of Doxycycline in Patients With Amyloidosis
A Phase 2 study, sponsored by Boston University.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01677286 is a Phase 2 study that has completed, run by Boston University. The registered enrollment target is 25 participants.
The verdict
NCT01677286, a Phase 2 study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Doxycycline 100 mg po bid x 12 months
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-12-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01677286
The ClinicalTrials.gov registry entry for NCT01677286 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Doxycycline 100 mg po bid x 12 months is the first listed.
NCT01677286 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01677286 about?
NCT01677286 is a clinical study titled "Safety and Effect of Doxycycline in Patients With Amyloidosis". 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 ...
What is the current status of trial NCT01677286?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2012-07. Estimated completion is 2015-12-15.
What interventions are being tested in trial NCT01677286?
The interventions under investigation include: Doxycycline 100 mg po bid x 12 months (DRUG).
Who is sponsoring clinical trial NCT01677286?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.