Frontiers Clinical and Translational Science Unit
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Transcript of Frontiers Clinical and Translational Science Unit
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Frontiers Clinical and Translational Science Unit
Jeffrey M. Burns, MD, MSEdward H. Hashinger Associate Professor of
NeurologyDirector, Clinical and Translational Science Unit
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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
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What is the CTSU?• Supports research activity
– Physical Infrastructure• 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
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KU Clinical Research Center
http://www.youtube.com/watch?v=zsMBazY31S0
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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
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Infusion Center• 11 infusion suites for
drug administration and pharmacokinetic studies
• Investigational pharmacy in the Clinical Research Center
• Nursing support
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Sample Processing Lab
• Refrigerated centrifuges• Microcentrifuge• YSI glucose analyzer• -80 freezers for short or
long term specimen storage
• -20 freezer and refrigerator
• Dry Ice
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KU Alzheimer’s Disease Center
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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
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KU ADC Integration with the CTSU
Space• Clinical Evaluations• Cognitive TestingNursing• Blood draws• Study Drug Infusions• Glucose Tolerance Tests• Clamp Procedures
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Safety and Tolerability of R(+) Pramipexole in Alzheimer’s Disease (SPA)
• 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
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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)
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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
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Exercise Physiology Laboratory 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
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Exercise Physiology Laboratory
2 Dexa ScannersProdigy DPXiDXA
Advanced Adipose Imaging
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Exercise Physiology Laboratory
Exercise Training Interventions
Resistance (Weight) Training
Treadmill Training
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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
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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)
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Metabolic and Demonstration Kitchens
• Assessment of dietary intake • Direct or digital photograph
observation• 24-hour recalls• Food records• Food frequency questionnaires• Screeners
• Nutrition interventions– Recipe Development and Testing– Research diets / Controlled feeding
protocols– Standardized meals
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KU ADC Integration with the CTSU
Space• Clinical Evaluations• Cognitive TestingNursing• Blood draws• Study Drug Infusions• Glucose Tolerance Tests• Clamp Procedures
Exercise Physiology• Physical function testing• Maximal Exercise Testing• DEXA• Resistance exercise trainingDemonstration Kitchen• Healthy Cooking Class
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Brain Atrophy
Vascular Changes
Markers of Alzheimer’s
Brain Aging Project:The role of lifestyle factors in brain aging and Alzheimer’s disease
• Physical Activity– Exercise and fitness
• Diet / Metabolism– Insulin / glucose– Body composition
• Obesity (fat-mass), muscle mass
• Mental Activity
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Cardiorespiratory Fitness:Oxygen Consumption
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Higher Physical Fitness is Associated with Less Brain Atrophy
Burns et al, Neurology, 2008
Fitness associated with less atrophy in brain areas most affected by AD
Honea et al, Alz Dis Assoc Dis, 2009
Fitness Level
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Lean Mass in AD• Lower lean mass in AD• Associated with brain atrophy and cognition
Burns et al, Archives Neurology 2010
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Bone Density and Bone Loss in AD
p=0.02
BaselineBone Density 2-yr Bone Loss
Loskutova et al., JAD, 2009
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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
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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)
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CTSU without Walls
• CTSU Satellite– Clinical space on main campus (Delp)
• Mobile nurses• Research Coordinators
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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
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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
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Participant Recruitment
• Research Participant Registry• Pioneers program
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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
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Pioneers Community Registry• Web-based Community Registry
– PI: Patricia Kluding, PhD– Branding, website development ongoing
• 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
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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
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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
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CTSU Charges
• 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
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CTSU ChargesMedication Administration• Infusion Charge 87.50 • PO, SC or IM 25.00
• Physical Exam MD/NP 100.00 Exercise Physiology Testing• Exercise Physiologist Support 37.50/hr. Dexa• Hip/spine/forearm 50.00• Total body 50.00
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CTSU ChargesExercise Tests• Submaximal test 75.00• Submaximal or max w/ EKG 100.00
• Metabolic cart / resting metabolic rate 50.00
Ultrasound blood flow measures 75.00/subject 50.00/subject for device only
• Conference Room 25.00/hr• Demonstration Kitchen 100.00/hr
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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