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NCT01056965 · ClinicalTrials.gov registry record · Phase 1
Davunetide (AL-108) in Predicted Tauopathies - Pilot Study
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01056965 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 12 participants.
The verdict
NCT01056965, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The primary objective of the study is to obtain preliminary safety and tolerability data with davunetide (NAP, AL-108) in patients with a tauopathy (frontotemporal lobar degeneration \[FTLD\] with predicted tau pathology, corticobasal degeneration syndrome \[CBS\] or progressive supranuclear palsy \[PSP\]). The secondary objectives of this study are to obtain preliminary data on short term changes (at 12 weeks) in a variety of clinical, functional and biomarker measurements from baseline, including cerebrospinal fluid (CSF) tau levels, eye movements, and brain MRI measurements.
Interventions
- DRUG Placebo nasal spray
- DRUG davunetide (AL-108, NAP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01056965
The ClinicalTrials.gov registry entry for NCT01056965 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo nasal spray is the first listed.
NCT01056965 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01056965 about?
NCT01056965 is a clinical study titled "Davunetide (AL-108) in Predicted Tauopathies - Pilot Study". The primary objective of the study is to obtain preliminary safety and tolerability data with davunetide (NAP, AL-108) in patients with a tauopathy (frontotemporal lobar degeneration \[FTLD\] with predicted tau pathology, corticobasal degeneration syndrome \[CBS\] or progressive supranuclear palsy \...
What is the current status of trial NCT01056965?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-01. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01056965?
The interventions under investigation include: Placebo nasal spray (DRUG), davunetide (AL-108, NAP) (DRUG).
Who is sponsoring clinical trial NCT01056965?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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