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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: Completed Phase 2 study, sponsored by Boston University.
NCT01677286 is a Phase 2 study that has completed, run by Boston University. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at end of study reported
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 |
What the finished NCT01677286 record still lists
NCT01677286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
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 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01677286's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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