Clinical Research Studies
Below you will find clinical research studies we are currently involved with. Click the plus ‘+’ icon to the right for further details on any particular study.
Patients who have had a recent stroke that affects the function of either upper limb may consider being evaluated for possible enrollment into this clinical trial. The clinical trial will be evaluating a medication that is thought to improve mobility and function of the affected limb while on study medication and undergoing therapy.
Ischemic Stroke Study: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, 21-Day Treatment Study, Including fMRI Sub-Study to Evaluate the Effect of HT-3951 on Upper Extremity Motor Function Following Ischemic Stroke Primary Outcome Measures:
Primary Outcome Measures:
- Fugl-Meyer Assessment of Upper Extremity, Part A-D
- Index Finger-Tapping Frequency Test
- Nine-Hole Peg Test
- Hand Grip Strength Dynamometer Test
- Arm Motor Ability Test-9
- Stroke Impact Scale (hand domain)
- Somatosensory evoked potential
Secondary Outcome Measures:
- Two-Minute Walk Test
- Behavioral, neural activity and motor network connectivity levels, using functional MRI
*study will pay for SOC PT/OT if insurance is exhausted or subjects do not have insurance.
This is an exciting trial looking at a medication that is thought to have an impact on amyloid accumulation thus possibly changing the progression of Alzheimer’s Dementia.
Mild Alzheimer’s Disease Dementia: A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer’s Disease Dementia.
Primary Outcome Measures:
- Change from Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog-13) Score
Secondary Outcome Measures:
- Change from Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items Score
- Change from Baseline in Functional Activities Questionnaire (FAQ) Score
- Change from Baseline on the Integrated Alzheimer’s Disease Rating Scale (iADRS) Score
- Change from Baseline in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score
- Change in Clinical Dementia Rating (CDR) Global Score
- Change from Baseline in Neuropsychiatric Inventory (NPI) Score
- Change from Baseline on the Mini-Mental State Examination (MMSE)
- Change from Baseline in Concentration of Cerebrospinal fluid (CSF) Biomarker Aβ1-42
- Change from Baseline in Concentration of CSF Biomarker Aβ1-40
- Change from Baseline in CSF Biomarker Total Tau
- Change from Baseline in CSF Biomarker Phosphorylated Tau Change from Baseline in Brain Amyloid Burden using Florbetapir Amyloid Scan
- Change from Baseline in Regional Cerebral Blood Flow (rCBF) using Florbetapir Perfusion Scan
- Change from Baseline in Whole Brain Volume
- Population Pharmacokinetics (PK): Apparent Oral Clearance of LY3314814
- Population PK: Central Volume of Distribution of LY3314814
This is a study of patients who are on Plegridy. It is a long term observational study to better qualify and quantify the effectiveness and safety of this medication.
Relapsing Remitting MS Plegridy Observational Program (POP): Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program
Primary Outcome Measures:
- Safety as measured by the incidence proportion of SAEs
- Safety as measured by the incidence rate of SAEs
- Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses
- Clinical NEDA as measured by the proportion of participants with no disability progression
Secondary Outcome Measures:
- Prescription and utilization patterns as measured by prescribed dosing frequency
- Prescription and utilization patterns as measured by duration of Plegridy use
- Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy
- Relapse activity as measured by annualized relapse rate (ARR)
- Relapse activity as measured by time to first relapse
- Relapse activity as measured by the proportion of participants with relapse
- Relapse activity as measured by the distribution of the number of relapses
- Disability progression as measured by the proportion of participants with sustained progression for at least six months