Welcome to Neurology Clinical Research!

Message to UCDenver Faculty and Staff:


Neurology is one of the largest Clinical Research enterprises in the University of Colorado School of Medicine



 

Number of Neurology Clinical Research Staff 79
59 clinical staff (includes 1 nurse and 2 Physical Therapists)
 20 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
627 per month
Number of Clinical Research Participant Visits 5,334
*14% increase from previous CY24
Top Clinical Research Visit Location Outpatient CTRC
*1,929 visits

 

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).

Neurology Clinical Research Study Statuses CY 2025

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

Neuro Clinical Research Statuses CY 2025
Neurology Clinical Research Study Statuses CY 2025 
Active, Closed to Accrual
90
Active, Open to Accrual
133
In Start-Up42
Secondary Use97
CY Total
362

 

Neurology Clinical Research CY 2020-2024 Growth Comparison

Neurology Clinical Research Five Year Growth Comparsion
All Studies Statuses2021 2022 2023 2024 2025
Active, Closed to Accrual
61 54 63 7990
Active, Open to Accrual
147 184 126 136133
In Start-Up49 55 48 6042
Secondary UseN/A
N/A 96 9797
CY Total
257293
 333 372362

 

Subspecialty CY 2025 Clinical Study Statistics

*Excludes secondary use/chart review

Total Studies by Subspecialty CY 2025
Subspecialty
Total Studies
Behavioral Neurology23
Epilepsy16
Headache/Pain4
Movement Disorders71
Neuro-Hospitalists13
Neuro-Immunology + Autoimmune
73
Neuro-Muscular
55
Neuro-Oncology0
Neuro-Ophthalmology10

 

Grant Summary CY 2025

Grant Statuses 2023 2024 2025
Grants/Applications Submitted 61 82 129
Grants Awarded (includes internal awards) 25 30 44
Total Grants Awarded Funding Amount $8,976,248.80 $13,174,821 $7,491,313
IPAs 4 3 1
(2 completed 7/31/25)
IPA Total Funding $274,898.61 $192,632 $33,806
Total Combined Funding (Awards/IPAs) $9,251,147.41$13,367,453$7,525,119
Pending Decision 24 34 26
Submitted but not awarded 24 21 23

Highlighted Studies CY 2025

Study PI Subspecialty Highlight
Longitudinal Frontotemporal Lobar Degeneration, Cycle 2 (ALLFTD2) Bayram Behavioral Neurology 5-year renewal on U19 Subaward with Mayo Clinic. Total award amount (indirects + directs) = $1,010,100. Period of Performance: 9/15/2025-9/14/2030.
A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention The APT Comparison Study Caunt Headache A PCORI subaward for Mayo. First participant enrolled in December 2025 and Dr. Caunt as a new PI.
Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis Eklund Neuro-Hospitalist StrokeNET study with two participants enrolled in 2025.
Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on Recovery (DISCOVERY) Simpson Neuro-Hospitalist An NIH subaward for Mass General.  One of the top five enrolling sites in Q3/2025. Our site has consented 129 overall.
Parkinson’s Progression Markers Initiative (PPMI) Clinical – Establishing a Deeply Phenotyped PD Cohort Fullard Movement Disorders One of the top three enrolling sites, selected for PPMI Coordinator Council and PPMI Mentor with 97% participant retention rate.
exPDite-2: A Phase 3 Study to Assess the Efficacy and Safety of Midbrain Dopaminergic Neuronal Cell Therapy (Bemdaneprocel) for Participants With Parkinson’s Disease Baumgartner Movement Disorders Part of the strategic partnership between CU and Bayer. First screening December 2025.  We have worked closely with Dr. Ginde on this study with the CU/Bayer partnership.
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) Piquet Neuro-Immunology Highest enrolling site with 14 screened and first CAR-T in SPS.
Prospective Evaluation of De-Escalation from antiCD-20 Therapies to Ozanimod  Alvarez Neuro-Immunology Our first lead site of a multi-center treatment drug study with 13 sites.  Our site is the highest enrolling site with 29 consented.
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD) Quan Neuromuscular This study has a 50% screen fail rate, but we have 0 screen failures and 4 active participants. The sponsor has asked our site to take on 5 transfer participants because of our success.
HEALEY ALS Platform Trial Foster Neuromuscular Over $1M in support for 8 regimens, and testing 7 new ALS investigational drugs in just over 5 years

New to Clinical Research?  

Learn more about clinical research by visiting the following resources:  

  • What are Research Studies? by the University of Colorado Anschutz Medical Campus Research Studies Team
  • The Center for Information and Study on Clinical Research Participation (CISCRP) is first-of-its-kind nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research and the role each party plays in the process.
    • The CISCRP Community Resources webpage contains a number of contact information-containing resources available to anyone seeking information about clinical research, both general and disease-specific.
  • Clinicaltrials.gov Glossary of Common Site Terms
  • The National Institutes of Health (NIH) - Clinical Trails and You
  • PubMed is a free (as in money) resource supporting the search and retrieval of biomedical and life sciences literature with the aim of improving health–both globally and personally.
  • Access for ALL in ALS - Funded by the National Institutes of Health (NIH), the Access for ALL in ALS Consortium (ALL ALS), is a community of two coordination centers and 35 research sites across the United States, conducting a combined longitudinal natural history study and biomarker collection study for ALS. ALL ALS research engages with people currently living with ALS, potential ALS gene carriers, and family members, friends, and community partners to better understand all stages of ALS disease progression.

 

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 [email protected] .

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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.
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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!

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Neurohospitalist/ Inpatient Neurology

Interested in Active Enrolling Studies

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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 N[email protected] or 303-724-4644.

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