Transcript Frontiers Clinical and Translational Science Unit

Frontiers Clinical and
Translational Science Unit
Jeffrey M. Burns, MD, MS
Edward H. Hashinger Associate Professor of
Neurology
Director, Clinical and Translational Science Unit
What is the CTSU?
• Clinical and Translational Science Unit
– NIH-Funded
• A program of Frontiers: Heartland Institute of
Clinical and Translational Research
– The new GCRC
• Main unit is in the new Clinical Research Center
• CTSU satellite
• CTSU without walls program
What is the CTSU?
• Supports research activity
– Physical Infrastructure
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Clinic rooms
Infusion center
Exercise physiology
Sleep lab and beds for extended stays
Metabolic kitchen
– Nursing
– Coordinators
– Recruitment Program
• Registry
• Pioneers Community Registry
– CTSU Satellite / CTSU Without Walls program
KU Clinical Research Center
http://www.youtube.com/watch?v=zsMBazY31S0
Clinical Space
• 17 exam rooms for multi-purpose
outpatient testing
• 2 Cognitive testing rooms
• 2 Isolation exam rooms, designed
for smoking cessation studies or
infectious disease studies
• 2 clinical rooms with observation
capability via a one-way window
• Workspace for up to 8 study
coordinators to set up for the day
while in the CTSU
Infusion Center
• 11 infusion suites for
drug administration
and pharmacokinetic
studies
• Investigational
pharmacy in the
Clinical Research
Center
• Nursing support
Sample Processing Lab
• Refrigerated
centrifuges
• Microcentrifuge
• YSI glucose analyzer
• -80 freezers for short or
long term specimen
storage
• -20 freezer and
refrigerator
• Dry Ice
KU Alzheimer’s Disease Center
A National NIA-Designated
Alzheimer’s Disease Center
• Build and develop regional AD and brain aging
research programs
– We conduct and enable all types of AD research
• World leader in AD/age-related brain energy
metabolism research
• Research infrastructure organized by “Cores”
– Clinical Core with 400 carefully characterized
subjects
KU ADC Integration with the
CTSU
Space
• Clinical Evaluations
• Cognitive Testing
Nursing
• Blood draws
• Study Drug Infusions
• Glucose Tolerance Tests
• Clamp Procedures
Safety and Tolerability of R(+) Pramipexole in
Alzheimer’s Disease (SPA)
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Study of safety of (R+) pramipexole in AD
Antioxidant; being tested in ALS
No Placebo
6 month treatment period
– Biomarker assessments (CSF)
– FDG PET
– Cognitive testing
Alzheimer’s Disease Neuroimaging Initiative-2
(ADNI-2)
• Evaluate clinical and “biomarker” parameters
in control, MCI, AD subjects
– Cognitive testing
– Imaging (MRI, FDG PET, amyloid PET)
– Genetic (blood)
– Biomarkers (blood, CSF)
• Longitudinal (4.5 years)
• Observational (no intervention)
Exercise Physiology Laboratory
 Exercise Physiologist, ACSM Certified
 Maximal Graded Exercise Testing with
Medical Monitoring
 Two Parvo Medics Metabolic Carts
 Physical Function Testing
 Quantitative Muscle Assessment
 EMG and Nerve Conduction Studies
Exercise Physiology Laboratory
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Pulmonary Function Testing
Quantitative Sensory Testing
Doppler Ultrasound
Multiple Modalities and Protocols
 Treadmill
 Cycle
 Recumbent Stepper
 Upper Body Ergometer
 2 DEXA scanners
 Body composition , bone density
Exercise Physiology Laboratory
2 Dexa Scanners
Prodigy DPX
iDXA
Advanced Adipose
Imaging
Exercise Physiology Laboratory
 Exercise Training Interventions
 Resistance (Weight) Training
 Treadmill Training
Exercise Physiology Laboratory
QSART + Tilt Table
 Autonomic Function Testing (WR Medical)
 QSART: quantitative sudomotor axon
reflex test, sympathetic cholinergic
function
 Reflexive cardiovagal function: eg. Heart
rate response to deep breathing
 Reflexive sympathoneural function
 Orthostatic intolerance
Extended Observation Unit /
Sleep Lab
• Extended Observation
Unit (EOU) to allow
evening stays
• 3 hospital-style suites
• Study drug
administration,
observation & PK lab
draws
• Sleep Program opened
in October 2012
(Suzanne Stevens)
Metabolic and Demonstration Kitchens
• Assessment of dietary intake
• Direct or digital photograph
observation
• 24-hour recalls
• Food records
• Food frequency questionnaires
• Screeners
• Nutrition interventions
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Recipe Development and Testing
– Research diets / Controlled feeding
protocols
– Standardized meals
KU ADC Integration with the
CTSU
Space
• Clinical Evaluations
• Cognitive Testing
Nursing
• Blood draws
• Study Drug Infusions
• Glucose Tolerance Tests
• Clamp Procedures
Exercise Physiology
• Physical function testing
• Maximal Exercise Testing
• DEXA
• Resistance exercise training
Demonstration Kitchen
• Healthy Cooking Class
Brain Aging Project:
The role of lifestyle factors in brain aging and Alzheimer’s disease
• Physical Activity
Brain
Atrophy
– Exercise and fitness
• Diet / Metabolism
– Insulin / glucose
– Body composition
• Obesity (fat-mass),
muscle mass
Vascular
Changes
• Mental Activity
Markers of Alzheimer’s
Cardiorespiratory Fitness:
Oxygen Consumption
Higher Physical Fitness is Associated with Less
Brain Atrophy
Fitness associated with less atrophy
in brain areas most affected by AD
Fitness Level
Burns et al, Neurology, 2008
Honea et al, Alz Dis Assoc Dis, 2009
Lean Mass in AD
• Lower lean mass in AD
• Associated with brain atrophy and cognition
Burns et al, Archives
Neurology 2010
Bone Density and Bone Loss in AD
Baseline
Bone Density
p=0.02
Loskutova et al., JAD, 2009
2-yr Bone Loss
Trial of Resistance Training Increased
Alzheimer’s Susceptibility (TORTIAS)
Does Building Muscle Build Brain?
• A study of weight lifting for people without
memory problems
– Eligible: 55-75 years olds who aren’t weight lifting
– Commitment: 2 hours/week for 12 weeks
– What do we measure before and after exercise?
• Brain structure (MRI)
• Brain function (fMRI)
• Muscle mass
Insulin for Memory (INFORM)
• Evaluate insulin resistance-memory relationships
• One 6 hour visit
– hyperinsulinemic-euglycemic clamp (tests insulin
resistance)
– memory testing
– DEXA scan (defines body composition)
CTSU without Walls
• CTSU Satellite
– Clinical space on main campus (Delp)
• Mobile nurses
• Research Coordinators
Research Coordinator Pool Service
 $60 per hour or % FTE
 Contract with PI for services
 Coordinator may provide services
including
 Regulatory processing for the trial
 Coordinating and conducting study
visits
 Performing study-required procedures
 Documentation
 Assisting with monitor visits
 Many other tasks and duties
Clinic in the CTSU
• December 2012: 6 rooms will be
dedicated to support clinical activity
• Clinicians who are doing research in the
CTSU can host clinic in the CTSU
Participant Recruitment
• Research Participant Registry
• Pioneers program
Research Participant Registry Program
 Comprehensive registry of KUMC patients willing to be
contacted for participation in research studies
 4 clinics started in 2009, now active 17 clinics
 13,206 enrolled in registry by September 2012
 17 researchers have received contact information for
25 protocols (7 PhDs, 8 MDs, 1 PharmD and 1 MSPT)
 148 participants identified from the registry have been
enrolled in protocols
Pioneers Community Registry
• Web-based Community Registry
– PI: Patricia Kluding, PhD
– Branding, website development ongoing
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Single sign-up process
Open to all Frontiers investigators
Powerful search options with EMR access
No cost to investigators to manage database,
search for participants
• Able to screen with study-specific questions
Become a Pioneer!
• Electronic informed consent form
• Email verification
• Brief redcap survey:
– Demographic and contact info
– Medical history info (self report)
– Option to link to EMR if KUMC patient
• Can register self, children, family member
/ surrogate
Summary of CTSU
• The purpose of the CTSU is to support
research by providing
– Space
– Nursing / coordinators
– Access to important resources
• Exercise physiology
• Overnight stay and sleep lab capabilities
• Metabolic kitchen
– Recruitment tools
• Frontiers Registry, Pioneers Program
CTSU Charges
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Room rate (Minimum 1 hr. fee) 12.50/hr.
Vital Signs, Height, Weight
12.50/hr.
Phlebotomy
12.50/hr.
Specimen processing
12.50/hr.
Spirometry
50.00
Glucose Tolerance Test
100.00
Pregnancy Test
5.00
EKG
35.00
Skin caliper test
5.00
CTSU Charges
Medication Administration
• Infusion Charge
• PO, SC or IM
87.50
25.00
• Physical Exam MD/NP
100.00
Exercise Physiology Testing
• Exercise Physiologist Support
37.50/hr.
Dexa
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Hip/spine/forearm
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Total body
50.00
50.00
CTSU Charges
Exercise Tests
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Submaximal test
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Submaximal or max w/ EKG
75.00
100.00
• Metabolic cart / resting metabolic rate
50.00
Ultrasound blood flow measures
75.00/subject
50.00/subject for device only
• Conference Room
• Demonstration Kitchen
25.00/hr
100.00/hr
Contact Us
 Jeffrey Burns, MD, Director, CTSU
 913-588-0073, [email protected]
 Patricia Kluding, PhD, Associate Director, CTSU
 913-588-6918, [email protected]
 Jo Denton, RN, MSN, CCRC, Administrative Director, CTSU
 913-588-0046, [email protected]
www.frontiersresearch.org