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University of Colorado Alzheimer's and Cognition Center Longitudinal Biomarker and Clinical Phenotyping Study (Bio-AD Study)
This study will establish a large bank of samples and data for future research into the causes of and treatments for Alzheimer’s disease (AD), Down Syndrome (DS) and other diseases that cause thinking and memory problems.... Protocol #: 15-1774 |
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Calibrating free-living physical activity characteristics across functionally-limited populations using machine-learned accelerometer approaches
Regular physical activity is known to have positive effects on many health outcomes. In research, physical activity is often measured using activity monitors worn on the hip, wrist or ankle. These instruments determine how much physical activity a person does based on the amount of movemen... Protocol #: 16-2706 |
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Conversational Speech in the Diagnosis of Neurocognitive Disorders
Using elements of conversational speech such as tone of voice and duration of speaking is a cheap, non-invasive way to gather information, which can be used to direct medical interventions that will help slow or prevent the progression of neurological disease. ... Protocol #: 18-0456 |
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Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
This research studies how hormones impact headache and how different parts of the brain talk to each other. You are invited to participate if you are (or your child is): • 9 years to 20 years of age • With or without history of headache • Male sex, male gender identity • Health... Protocol #: 20-1824 |
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Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD)
The purpose of this research study is to learn more about the safety and effectiveness of a drug called sargramostim for improving cognitive function and memory in people with Alzheimer’s disease. ... Protocol #: 19-2727 |
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Teen Brain Imaging Study
Irritability in youth is associated with anxiety, depression and suicidality later in life. Treating irritability early may prevent negative outcomes. A promising way to treat irritability is to address negative bias. Understanding biased social judgments has become a major focus of soci... Protocol #: 20-2633 Location: CU Anschutz non-hospital research facilities |
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A PHASE I, MULTICENTER, OPEN-LABEL,UNCONTROLLED STUDY TO EVALUATE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY, AND TOLERABILITY OFSATRALIZUMAB IN ADULT PATIENTS WITH AQP4 ANTIBODYPOSITIVE NEUROMYELITIS OPTICA SPECTRUM DISORDER WITH BODYWEIGHT 100 KG
Protocol #: 22-1981 Location: Outpatient CTRC, University of Colorado Hospital |
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A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and its Individual Components
Protocol #: 22-1962 Location: Outpatient CTRC, University of Colorado Hospital |
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MECHANISTIC INVESTIGATION OF THERAPIES FOR DOWN SYNDROME REGRESSION DISORDER
Individuals with Down syndrome (DS) have an increased risk of numerous co-occurring conditions, including the neuropsychiatric condition known as Down Syndrome Regression Disorder (DSRD). A DSRD diagnosis often includes a sub-acute onset of catatonia, mutism, depersonalization, loss of abi... Protocol #: 22-1992 Location: Childrens Hospital Colorado |
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Mindfulness-Based Intervention for Adolescents with Chronic Migraine
Learning from YOU will help us improve a program that can help teens with chronic migraine live a better life! We would like to interview you and your parent for 1 hour each. Interviews can be over Zoom or in person. Interviews will help us understand your experience living with migr... Protocol #: 22-2359 Location: Childrens Hospital Colorado |
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A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EDG-5506 on Safety, Biomarkers, Pharmacokinetics, and Functional Measures in Adults and Adolescents with Becker Muscular Dystrophy
Protocol #: 22-0354 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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A PHASE III, RANDOMIZED, DOUBLE-BLIND,
PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY,
SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN
PATIENTS WITH ANTIN-METHYL-D ASPARTIC ACID RECEPTOR (NMDAR) OR ANTILEUCINE-RICH GLIOMA-INACTIVATED 1 (LGI1) ENCEPHALITIS
Protocol #: 22-0449 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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REDUCE Post Approval Study - GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO)
This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.... Protocol #: 19-6030 Location: Harmony Campus, Medical Center of the Rockies |
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A Two-year Prospective Natural History Study Examining the Use of Neuronal Injury Biomarkers in Autoimmune Encephalitis as a Potential Biomarker for Disease Activity and Severity
Protocol #: 19-0889 Location: Brain Imaging Center (BIC), Childrens Hospital Colorado, Colorado Research Center, University of Colorado Hospital |
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A Phase 1, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study with an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects with Progressive Multiple Sclerosis (ATA188-MS-101
Protocol #: 20-0454 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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Embolization of the Middle Meningeal Artery with ONYX(TM) Liquid Embolic System in the Treatment of Subactue and Chronic Subdural Hematoma (EMBOLISE)
The purpose of this study is to evaluate the safety (short and long term side effects) and effectiveness (how well it helps) of Onyx Liquid Embolic System(LES) (study device) embolization of the middle meningeal artery when used in addition to the standard treatment that is used to treat a... Protocol #: 20-1390 Location: University of Colorado Hospital |
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A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous ganaxolone in status epilepticus
Status Epilepticus is a serious condition that needs fast treatment to stop the seizures and prevent permanent brain damage. Ganaxolone is an investigational drug, which means that it is not approved by the US FDA. The study drug will be added on to the usual care patients will already be ... Protocol #: 20-1641 Location: University of Colorado Hospital |
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A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS
Protocol #: 20-1852 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS
Protocol #: 20-2036 Location: Brain Imaging Center (BIC), University of Colorado Hospital |
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ALZHEIMER'S CLINICAL TRIAL CONSORTIUM FOR DOWN SYNDROME (ACTC-DS)
TRIAL-READY COHORT - DOWN SYNDROME (TRC-DS)
TRC-DS is part of a larger movement working with people with Down syndrome to advance Alzheimer's disease therapies and potential cures for this population. The Alzheimer's Clinical Trials Consortium-Down Syndrome (ACTC-DS) is a large collaboration of researchers conducting clinical trials... Protocol #: 20-2692 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Treatment for Alcohol Use Disorder: Emotion Regulation and Brain Function
This study plans to learn more about the brain's role alcohol use problems and recovery. Prominent theories about alcohol use disorder suggest that it is a disorder of the brain. However, it remains unclear what parts of the brain work differently in alcohol use disorder. This study intend... Protocol #: 20-3000 Location: Brain Imaging Center (BIC), University of Colorado Hospital |
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A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB, COMPARED WITH OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS.
Protocol #: 21-2663 Location: Brain Imaging Center (BIC), University of Colorado Hospital |
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 2 STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ROZANOLIXIZUMAB IN ADULT STUDY PARTICIPANTS WITH LEUCINE-RICH GLIOMA INACTIVATED 1 AUTOIMMUNE ENCEPHALITIS
Protocol #: 21-2955 Location: Brain Imaging Center (BIC), Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3, PIVOTAL STUDY WITH AN OPEN-LABEL EXTENSION PERIOD TO EVALUATE THE
EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT
PARTICIPANTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN (MOG)
ANTIBODY-ASSOCIATED DISEASE (MOG-AD)
Protocol #: 21-3747 Location: Brain Imaging Center (BIC), University of Colorado Hospital |
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AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of fatumumab 20mg SC Monthly in Treatment Naive, Very Early Relapsing Remitting Multiple
Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.
Protocol #: 21-4783 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib 100 mg b.i.d. versus teriflunomide 14 mg q.d. in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib
Protocol #: 21-4825 Location: Brain Imaging Center (BIC), CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2, 6-MONTH STUDY
TO EVALUATE THE SAFETY, TOLERABILITY AND EXPLORATORY EFFICACY OF CT1812
IN SUBJECTS WITH MILD TO MODERATE DEMENTIA WITH LEWY BODIES
Protocol #: 22-0669 Location: Brain Imaging Center - BIC, Outpatient CTRC, University of Colorado Hospital |
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A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO ASSESS SAFETY AND EFFICACY OF SLS-005 (TREHALOSE INJECTION, 90.5 MG/ML FOR INTRAVENOUS INFUSION) FOR THE TREATMENT OF ADULTS WITH SPINOCEREBELLAR ATAXIA
Protocol #: 22-1127 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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NRG-BN011, A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma (NCT 05095376)
Protocol #: 22-1113 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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A PHASE II, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE PHARMACODYNAMICS, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF RO7204239 IN PARTICIPANTS WITH FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY
Protocol #: 22-1495 Location: Brain Imaging Center (BIC), Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital |
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A 2-part Phase 2 Study of Safety, Pharmacokinetics and Biomarkers
in Children with Duchenne Muscular Dystrophy including a Randomized, Double-Blind, Placebo-Controlled Part A, Followed by an Open-Label Part B
This is a 2-part multi-center, Phase 2 study to evaluate the effect of EDG-5506 on safety, PK and biomarkers of muscle damage in approximately 27 children with DMD treated with oral, once daily EDG-5506 for 12 months. Part A will include a 12-week, randomized, double-blind, placebo-contr... Protocol #: 22-1823 Location: Childrens Hospital Colorado |
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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)
Protocol #: 22-2179 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2
Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091
Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple
Sclerosis
Protocol #: 22-2421 Location: Brain Imaging Center (BIC), Outpatient CTRC |
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A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to
Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke
Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
Protocol #: 23-0053 Location: Outpatient CTRC, University of Colorado Hospital |
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene
Protocol #: 23-0328 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB AS MONOTHERAPY OR IN ADDITION TO BASELINE THERAPY IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (MOGAD)
Protocol #: 23-0648 Location: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital |
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A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants with Parkinson's Disease
Protocol #: 23-0784 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |