Clinical
Research
• Creatine
Phase 3
(Enrollment completed 12/04)
• Minocycline Phase 3
(Enrollment completed 12/05)
• Arimoclomol Phase 2a
(Enrollment completed 1/06)
• Sodium Phenylbutyrate
Phase 2
(Enrollment completed 5/06)
• Selection Trial
(Enrollment
completed 9/06)
• Levetiracetam
(Enrollment
completed 11/06)
• ALSRG DNA Banking
(Enrollment
completed 1/07)
• Duke
Biomarker Study
(Enrollment
completed 8/07)
• Lithium in ALS
(coming in
late 2008)
• Arimoclomol Phase 2b/3
(Coming in 2009)
• Validation
of Biomarkers in Amyotrophic Lateral
Sclerosis (ALS)
http://www.clinicaltrials.gov/ct2/show/NCT00677768?term=als+biomarker&rank=1
(This
Trial is now open for enrollment at Duke;
call Karen at 919 668-2844 to arrange a
screening visit!!)
• Phase
3 Trial of Zenvia for patients with ALS and
pseudobulbar affect.
For details of this trial, see
http://www.clinicaltrials.gov/ct2/show/NCT00573443?term=zenvia&rank=1
(This
Trial is now open for enrollment at Duke;
call Karen at 919 668-2844 to arrange a
screening visit!!)
Epidemiology
• VA
ALS Registry
(Enrollment
completed 9/07. See http://www.durham.hsrd.research.va.gov/alsregistry.asp
for details)
The Duke ALS Clinic is helping to
confirm cases of ALS within this Registry.
Also, we are part of multiple ongoing studies
that are working to determine why veterans
are at increased risk for ALS, and to understand
how care for veterans with ALS can be optimized.
Basic Science
• ALS
Cell Culture Study
(Ongoing)
The Duke ALS Clinic is partnering with the
Drexel ALS Clinic to create a spinal cord/cell
culture model of ALS. This model will shed
new light on the mechanisms of ALS at the
cellular level, and allow more rapid screening
of new potential ALS therapies. The black
and white picture below shows a mixture of
neurons and glial cells which have ALS-causing
mutations in them. These cells are growing
in a dish, where it is much easier to study
the important biochemical events which may
ultimately lead to their death. It may also
be possible to use this system to screen neuroprotective
drugs in a faster and more cost-effective
way.
The green picture below shows
one of the cells which is stained for Beta
III Tubulin, which is specific for neurons.
The red picture shows one of the cells stained
for GFAP which is specific for glial cells.
This new system should allow us to determine
how each individual cell contributes to ALS
development.
• Duke ALS Science Group Meets
A diverse collection of basic scientists, geneticists, engineers, therapists and physicians is now meeting monthly at Duke to develop translational "bench to bedside" projects for patients with ALS. The first of these to open for enrollment is the Duke Biomarker Study (see above for details). Look for many more unique and exciting research opportunities from this group in the very near future.
