Message to UCDenver Faculty and Staff:
Neurology is one of the largest clinical research enterprises in the University of Colorado School of Medicine, with over 333 active research studies/clinical trials in different phases of completion (study start-up, enrolling new participants, and follow-up of current participants). Our program includes over 92 staff who manage our research studies/clinical trials day-to-day. Additionally, our worldwide collaborators include experts from academic institutions and leaders in the clinical research field. In 2023, we had an average of 1,460 recruitment communications (phone, email, in-person contact, etc.) per month and 3,511 clinical research participant visits in total - a 24% increase from 2022!

Neurology Clinical Research Study Statuses CY 2024

*69% Non-Industry Funded, 31% Industry Funded

Neurology Clinical Research Study Statuses CY 2024
Neurology Clinical Research Study Statuses CY 2024 
Active, Closed to Accrual
79
Active, Open to Accrual
136
In Start-Up60
Secondary Use97
CY Total
372

 

Neurology Clinical Research CY 2020-2024 Growth Comparison

Neurology Clinical Research CY 2020-2024 Growth Comparison
All Studies Statuses2020 2021 2022 2023 2024
Active, Closed to Accrual
47 61 54 63 79
Active, Open to Accrual
118 147 184 126 136
In Start-Up53 49 55 4860
Secondary UseN/A
N/A N/A 96 97
CY Total
218257
 293 333372

 

Subspecialty CY 2024 Statistics

Subspecialty CY 2024 Statistics
Subspecialty
Total Studies: 372
Behavioral Neurology42
Epilepsy33
Headache/Pain4
Movement Disorders75
Neuro-Genetics1
Neuro-Hospitalists35
Neuro-Immunology + Autoimmune
104
Neuro-Muscular
55
Neuro-Oncology3
Neuro-Ophthalmology18
Neuro-Palliative
2

 

Staff, Recruitment, and Participant Statistics CY 2024

Staff, Recruitment, and Participant Statistics CY 2024
 
Number of Neurology Clinical Research Staff
91
69 clinical staff (includes 1 nurse and 2 Physical Therapists)
 22 administrative staff (budgeting/finance, regulatory, grant pre/post-award)
+ students and interns

Average Number of Recruitment Communication Contacts per Month
*Phone/email/in person by Recruitment Team

1,318 per month
Number of Clinical Research Participant Visits
4,670
*33% increase from previous CY23

Top Clinical Research Visit Location
Outpatient CTRC
*around 1,600 visits

 

Grant Summary CY 2024

Grant Statuses
20232024
Grants/Applications Submitted
61

82
Grants Awarded (includes internal awards)

25
30
Total Grants Awarded Funding Amount$8,976,248.80$13,174,821
IPAs43
IPA Total Funding$274,898.61$192,632
Total Combined Funding (Awards/IPAs)$9,251,147.41$13,367,453
Pending Decision
24

34
Submitted but not awarded
24

21

Note that these include several larger program grants including:
•    Nagel P01 (pending)
•    Potter P30 ADRC

Highlighted Studies CY 2024

Study
PISubspecialtyHighlight
Investigating the Contribution of Peripheral versus Central Nervous System Immune Dysfunction to Cognitive Aging
Bettcher

Behavioral Neurology
Having consented 193 individuals, the study is finishing the last follow-up visits in January of 2025.
Phase 2 Study of CT1812 in Mild-to-Moderate Dementia with Lewy Bodies

Holden
Behavioral Neurology
CU was one of the 1st sites activated, and the trial showed 82% slowing in Neuropsychiatric symptoms, up to 91% slowing in cognitive decline, and 52% preservation in ADLs.   These results are leading to an anticipated fast-tracked Phase 3 clinical trial in individuals with Lewy Body Dementia.
Quantifying the Integrity of Sleep-Dependent Memory Processing in Pathological Aging and Alzheimer's Disease: Toward Inexpensive Electroencephalographic Wearable Applications
McConnell
Behavioral Neurology
R01 NIH grant to explore simple single-channel (EEG) sleep recordings to explore the development of a digital biomarker for monitoring brain health and detecting early Alzheimer's disease changes. These techniques will incorporate signal processing methods into cutting-edge machine learning models to develop predictive models that can serve as a powerful digital biomarker to detect pathological aging, predict cognitive decline, and detect early stages of Alzheimer's disease.
Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer’s Disease (SESAD) Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer’s Disease (SESAD)
Potter
Behavioral Neurology
The SESAD study continues to enroll, and in 2024, as compared to 2023, and has increased consents 385%, and randomization by 125%.
Parkinson’s Progression Markers Initiative (PPMI) Clinical – Establishing a Deeply Phenotyped PD Cohort
Fullard
Movement Disorders
One of the top enrolling sites. 117 participants enrolled (DATscan, MRI, lumbar puncture, skin biopsy). Study led to validation of the synuclein seed amplification assay biomarker in Parkinson's disease and those at risk.
Removing Barriers to Deep Brain Stimulation Surgery for Women with Parkinson’s DiseaseFullardMovement DisordersFound gender differences in information needs, support, motivating factors, and how patients weighed risks and benefits. These findings have been incorporated into a DBS Decision Aid.
Implementation of adaptive deep brain stimulation to offset subthalamic dysregulation during exercise and reduce exertion in Parkinson’s disease.
Kern

Movement DisordersIt is one of the few centers in the world exploring the potential implementation of adaptive (closed-loop) DBS in PD. Other exploratory analyses include the effects of exercise on neurophysiological biomarkers, specifically local field potentials, which have never been performed.
LFP sensing from directional leads and associated clinical outcomes in the acute clinical setting      
Kern

Movement DisordersThis investigator initiative trial is the only one to have been performed in the world using this new technology recording directly from a DBS electrode monopolar sensing that can be used in the clinical setting.
A phase ib, open-label, multicenter study to investigate the pharmacokinetics, safety, and tolerability of subcutaneous ocrelizumab administration in patients with multiple sclerosisPiquet
Neuro-ImmunologyOur site was part of the Genentech project that showed the following in 2024: “Ocrelizumab SC delivers similar clinical benefits as ocrelizumab IV, with a favorable benefit–risk ratio. Ocrelizumab SC has the potential to provide greater flexibility in administration, and site of patient care.
Prospective Evaluation of De-Escalation from antiCD-20 Therapies to Ozanimod AlvarezNeuro-ImmunologyThis is a multi-center pilot study involving 10 sites and 100 participants. Our site is the lead site and acts as the study sponsor/CRO. 
Rocky Mountain Multiple Sclerosis Center (RMMSC) Biorepository for the Study of Neuroimmunological DisordersAlvarezNeuro-Immunology3522 blood collections and 1001 CSF collections.
A phase IV, prospective, multicenter, open-label, mother-milk study to evaluate ofatumumab concentration in the breast milk of lactating women with relapsing forms of multiple sclerosis receiving ofatumumab (Kesimpta®)ShahNeuro-ImmunologyOur site enrolled the first study participant worldwide, demonstrating our excellence in study recruitment.
A Phase 2 Open-Label, Single-Arm, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Treatment Refractory Stiff Person Syndrome (KYSA-8) PiquetAutoimmuneNot only are we the first site in the world to successfully dose a patient with Stiff Person Syndrome with CAR-T therapy, we are well on track to maintain our high enroller status. 
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) EncephalitisPiquetAutoimmuneOur site has currently enrolled over 50% of the participants in the US.
A Randomized, Double-blind, Placebo-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of AOC 1020 Administered Intravenously to Adult Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)QuanNeuromuscularThe sponsor has requested us to screen more patients in this very complex study and has transferred two patients from other sites due to our site’s excellent reputation.
Development and Adaptation of the ALSFRS-R Clinical Outcome Assessment for Remote-Use:
Comparability Study
FosterNeuromuscularThis study was being run directly by the FDA through a grant from the congressional bill: ACT for ALS.  We were able to forge an excellent working relationship with the FDA officer in charge such that she asked for our contract to be amended to allow our site to over-enroll beyond the original quota for all sites - which we did - and enabled the study to reach full enrollment within the tight deadline set forth by the grant.
Testing the utility of cell-free DNA as a biomarker for facioscapulohumeral muscular dystrophy (FSHD)Clinical research staffNeuromuscularThis study was a collaboration with the Department of Biochemistry & Molecular Genetics and the FSHD Society.  Through our work with FSHD Society, Neuromuscular staff saw an opportunity for a project and reached out to a CU professor whose lab is focused on FSHD research.  Neurology Research staff provided the regulatory and coordinator support to pull this project together VERY quickly.  It was conducted over the space of 11 hours at the FSHD CONNECT National Conference this summer.  5 Coordinators managed to organize and consent 110 participants and had successful blood draws on 99 of them in a hotel conference room.   We recently learned that ALL 99 samples -- even two that were difficult blood draws -- were usable, and the research team expects to be able to both publish and eventually patent the work that this project facilitated!


We offer a variety of Clinical Research:

  • Drug Studies
  • Non-drug Treatments and Interventions
  • Device Studies
  • Observational (blood draw studies, questionnaire studies)
  • Biobanking
  • Patient-reported Outcomes
  • Imaging (MEG, MRI, fMRI, PET scan)
  • Quality Improvements
  • Translational Lab and Tissue Bank
Many studies are Investigator-Initiated, or designed by our outstanding physicians. From observing their patients, these physicians pose important questions to investigate the difficult questions of neurological disorders. Other studies receive funding and support from pharmaceutical industries, private foundations, private donors, and government agencies such as the National Institute of Health (NIH).

New to Clinical Research?  

Learn more about clinical research by visiting the following resources:  

 

Common Terms:

  • Arm: a group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
  • Clinical study: a research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional studies (also called clinical trials) and observational studies.
  • Clinical trial: another name for an interventional study.
  • ClinicalTrials.gov identifier (NCT number): the unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).
  • Eligibility criteria: the key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.
  • Informed consent: a process used by researchers to communicate to potential and enrolled participants the risks and potential benefits of participating in a clinical study.
  • Intervention/treatment: a process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
  • Observational study: a type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment.
  • Placebo: an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
  • Principal Investigator (PI): the person who is responsible for the scientific and technical direction of the entire clinical study.
  • Protocol: the written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.
  • Research Services Professional (RSP): the title of clinical research coordinators at the University of Colorado. The RSP coordinates research visits and helps the PI carefully manage the participant’s care.
  • Sponsor: the organization or person who initiates the study and who has authority and control over the study.
  • U.S. Food and Drug Administration (FDA): an agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by making sure that human and veterinary drugs, vaccines and other biological products, medical devices, the Nation's food supply, cosmetics, dietary supplements, and products that give off radiation are safe, effective, and secure.

*all above definitions were copied from the Clinicaltrials.gov Glossary of Common Site Terms

 

Research is critical in helping to advance our knowledge of neurological diseases in order to best care for our patients. We also welcome Healthy Volunteers to participate in our studies!  Join us and become a part of the Neurology Clinical Research family as we aim to become a Center of Research Excellence!

For questions about our clinical research, please contact the Neurology Research Recruitment Team at 303-724-4644 or NeuroResearch@CUAnschutz.edu .

Local Neurology Events

11JUL-research-roadshow-QR

Shalom Park Research Roadshow

| 11:30 AM - 02:00 PM
Cost/fee: FREE
Join researchers from the CU Anschutz Medical Campus for a unique opportunity to engage in interactive and fun research activities!
Add event to:

2024 Walk to End Alzheimer's

| 08:00 AM - 05:00 PM
Cost/fee: FREE
The world's largest fundraiser for Alzheimer's care, support and research.
Add event to:

Clinical Research by Subspecialty

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Healthy Volunteers

Click to explore!

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Neuroimmunology

Autoimmune Encephalitis, Bio and Tissue Banks, Exercise Studies, First-degree Relatives of People with Multiple Sclerosis (MS), Healthy Volunteer Studies, Newly Diagnosed MS, Primary Progressive Multiple Sclerosis (PPMS), and Relapsing and Secondary Progressive Multiple Sclerosis (RSPMS).
Click to explore!

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Movement Disorders

Ataxia, Dystonia, Huntington’s Disease (HD), Multiple System Atrophy-Parkinsonian subtype (MSA-P), and Parkinson’s Disease (PD).
Click to explore!

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Neurobehavior

Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), Lewy Body Dementia (LBD), and Mild Cognitive Impairment (MCI).
Click to explore!

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Neuromuscular

Amyotrophic Lateral Sclerosis (ALS), Becker Muscular Dystrophy (BMD), Charcot Marie Tooth Disease (CMT), Diabetic Neuropathy (DN), Facioscapulohumeral Muscular Dystrophy (FSHD), Limb Girdle Muscular Dystrophy (LGMD), Myasthenia Gravis (MG), Myotonic Dystrophy Type 1 (DM1), and Spinal Muscular Atrophy (SMA).
Click to explore!

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Epilepsy

Focal Epilepsy, Idiopathic Generalized Epilepsy (IGE), Primary Generalized Tonic-Clonic Seizure (PGTCS), and Temporal Lobe Epilepsy (TLE).
Click to explore!

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Headache/Migraine

Chronic Migraine.
Click to explore!

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Neurovascular

Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL).
Click to explore!

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Neuro-Ophthalmology

Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOG-AD) and Neuromyelitis Optica Spectrum Disorder (NMOSD).
Click to explore!

Get Connected


If you think you may be eligible for one of these studies or if you would like more information, please fill out our Neurology Research Interest Web Form or contact us at NeuroResearch@CUAnschutz.edu or 303-724-4644.

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