
*69% Non-Industry Funded, 31% Industry Funded
Neurology Clinical Research Study Statuses CY 2024 | |
Active, Closed to Accrual | 79 |
Active, Open to Accrual | 136 |
In Start-Up | 60 |
Secondary Use | 97 |
CY Total | 372 |
All Studies Statuses | 2020 | 2021 | 2022 | 2023 | 2024 |
Active, Closed to Accrual | 47 | 61 | 54 | 63 | 79 |
Active, Open to Accrual | 118 | 147 | 184 | 126 | 136 |
In Start-Up | 53 | 49 | 55 | 48 | 60 |
Secondary Use | N/A | N/A | N/A | 96 | 97 |
CY Total | 218 | 257 | 293 | 333 | 372 |
Subspecialty | Total Studies: 372 |
Behavioral Neurology | 42 |
Epilepsy | 33 |
Headache/Pain | 4 |
Movement Disorders | 75 |
Neuro-Genetics | 1 |
Neuro-Hospitalists | 35 |
Neuro-Immunology + Autoimmune | 104 |
Neuro-Muscular | 55 |
Neuro-Oncology | 3 |
Neuro-Ophthalmology | 18 |
Neuro-Palliative | 2 |
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 Statuses | 2023 | 2024 |
Grants/Applications Submitted | 61 | 82 |
Grants Awarded (includes internal awards) | 25 | 30 |
Total Grants Awarded Funding Amount | $8,976,248.80 | $13,174,821 |
IPAs | 4 | 3 |
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
Study | PI | Subspecialty | Highlight |
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 Disease | Fullard | Movement Disorders | Found 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 Disorders | It 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 Disorders | This 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 sclerosis | Piquet | Neuro-Immunology | Our 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 | Alvarez | Neuro-Immunology | This 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 Disorders | Alvarez | Neuro-Immunology | 3522 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®) | Shah | Neuro-Immunology | Our 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) | Piquet | Autoimmune | Not 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) Encephalitis | Piquet | Autoimmune | Our 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) | Quan | Neuromuscular | The 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 | Foster | Neuromuscular | This 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 staff | Neuromuscular | This 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! |
Image: Anschutz Health Sciences Building (AHSB), the location of our outpatient Clinical and Translational Research Center (CTRC).
Learn more about clinical research by visiting the following resources:
Common Terms:
*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 .
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).
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Ataxia, Dystonia, Huntington’s Disease (HD), Multiple System Atrophy-Parkinsonian subtype (MSA-P), and Parkinson’s Disease (PD).
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Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), Lewy Body Dementia (LBD), and Mild Cognitive Impairment (MCI).
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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).
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Focal Epilepsy, Idiopathic Generalized Epilepsy (IGE), Primary Generalized Tonic-Clonic Seizure (PGTCS), and Temporal Lobe Epilepsy (TLE).
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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.