A Study to Evaluate an Investigational Drug (NLY01)Treatment to be used in Early-Stage Parkinson’s Disease
This research is studying a new drug, NLY01, in a large number of persons to learn about its effects in people with early-stage Parkinson’s disease (PD). Researchers want to know whether NLY01 helps lessen symptoms and signs of early PD, as well as slow the progression of the disease.
You will have a 2 in 3 chance of receiving NLY01 and a 1 in 3 chance of receiving a placebo, sterile salt water that looks like NLY01 but does not contain the study drug.
The total amount of time for you to be in the study will be approximately 45 to 54 weeks.
- Man or woman, at least 30 to 80 years old
- Have early-stage Parkinson's disease
- Not be on any current treatments for PD
- If of reproductive potential, willing and able to use a highly effective form of birth control during the study and for 30 days following last dose of study material
* Other criteria for eligibility apply
- Diagnosis of secondary or atypical parkinsonism
- Onset of any parkinsonian motor sign or symptom >5 years before Screening Visit
- Previous surgical procedure for PD
- Clinically significant medical, surgical, psychiatric, or laboratory abnormality
- Has an ECG or clinical evidence of potentially unstable heart disease
- Medical or recreational use of marijuana or THC-containing compounds within 3 months of the Screening Visit
* Other criteria for exclusion apply
A Study to Evaluate an Investigational Drug (tavapadon) as a Possible Treatment in Early Parkinson’s Disease
The main purpose of this study is to learn how well tavapadon (the study drug) works as a possible treatment for Parkinson’s disease and how safe the study drug is. The target dose range of tavapadon being studied is 5 to 15 mg once daily.
If you choose to participate in this study, you may receive the study drug, or you may receive placebo. A placebo is an inactive material, such as a sugar pill, that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
You will be in this study for approximately 35 weeks, which includes a screening visit and safety follow up, and you will need to come to the study center at least 11 times over this period.
You may be eligible if you:
• Are Between the ages of 40 to 80 years
• Are willing to practice effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial if you are a sexually active man or woman of childbearing potential
• Were diagnosed more than 3 years ago
• Willing and able to not use any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.
You will be excluded if you:
• Have a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post-stroke parkinsonism).
• Have had previous surgical intervention (eg, deep brain stimulation) for PD or for whom such a procedure is planned or anticipated during the trial period.
• Have hypertension.
• Have previously participated in any tavapadon trial, including this trial, and received IMP.
• Have received treatment with any other investigational drug within 60 days before signing the ICF.
A Study to Compare Medications in Patients with Advanced Parkinson's Disease
The purpose of this study is to find out how well ABBV-951 works to control Parkinson's disease symptoms compared to oral Carbidopa (CD)/Levodopa (LD). The study is also seeking to test whether ABBV-951 is well tolerated in patients with Parkinson's disease.
1. Male or female, age 30 or older
2. Has not received deep brain stimulation, Carbidopa (CD)/Levodopa (LD) enteral suspension, or any other Parkinson's Disease (PD) medication as continuous daily infusion
3. Subject does not have a history of significant skin conditions or disorders
4. Subject does not have a recent (within 6 months before screening) history of drug or alcohol abuse
5) Subject does not have a history or presence of psychotic episodes
6) Subject does not have other clinically significant unstable medical conditions
7) Subject must have a diagnosis of levodopa-responsive idiopathic PD
* other eligibility criteria to be discussed/reviewed with the study team
Decision-Making Abilities and Testamentary Capacity Among Older Adults
The overall goal of this research is to examine factors such as social resources, personality characteristics, and neurocognitive functioning in relation to decision-making abilities testamentary capacity among healthy older adults.
Another purpose of this research study is to evaluate the impact of Problem-Solving Treatment-Primary Care (PST-PC), a cognitive-behavioral therapeutic approach, on decision making among healthy older adults. PST-PC involves a seven-step model, in which participants identify problems to be solved, discuss and evaluate different resolutions to reach desired goals; create action plans to accomplish determined goals; and evaluate their effectiveness in resolving designated problems.
We will compare the effectiveness of PST-PC on individuals who will not receive any intervention.
A no treatment control group of older adult participants will also be recruited to compare the effectiveness of PST-PC to individuals who do not receive the intervention. This no treatment control group will composed of participants who do not receive the PST-PC sessions.
-adults aged 65 and older
- Must be independently-living and community-dwelling
- Participants must be willing to undergo a health interview to rule out outstanding medical and psychiatric conditions
- Adequate sensory abilities
- A history of psychiatric illness necessitating inpatient treatment
- Participants with self-reported depression and/or anxiety exceeding mild levels of clinical severity
A Study Utilizing Functional Feedback for Focused Ultrasound Thalamotomy for Tremor Surgery
The goal of this study is to understand if there are any changes to the connections between the cells in the brain before and after the ultrasound surgery for the treatment of Essential Tremor. This will be done by comparing patients who have had ultrasound surgery and Essential Tremor with healthy individuals. This study may help us to better target the tremor region in the brain during the ultrasound surgery.
- You must be between the ages of 40 and 85
- Willing to have MRI imaging of the brain
A Study of DBS-Expert system used during Deep Brain Stimulation For Parkinson's Disease
Deep Brain Stimulation (DBS) surgery is FDA approved for the treatment of Parkinson's Disease. The purpose of this study is to examine a technology (DBS-Expert system) that uses objective measurements to guide DBS programming. The DBS-Expert system analyzes motion data and provides recommendations to the physician or healthcare professional regarding DBS programming settings.
You may be eligible if you:
* Over the age of 18
* Able and willing to provide informed consent
* Clinical diagnosis of idiopathic Parkinson's Disease
* Implanted Boston Scientific DBS system
* You are currently participating in any study with an investigational medicinal product (IMP) or investigational device.
The ARCADIA Study -- A medication study for prevention of recurrent ischemic stroke
The purpose of this research study is to compare the effects (good and bad) of apixaban with the effects (good and bad) of aspirin in patients with unexplained strokes and atrial cardiopathy to see which is better at prevention of future strokes.
- You are at least 45 years old
- Clinical diagnosis of ischemic stroke* of unknown cause (ESUS or cryptogenic) in the last 120 days
- Underwent an echocardiogram as part of your stroke work up
- No history of atrial fibrillation (irregular heartbeat)
- No known allergy or intolerance to aspirin or apixaban
*An “ischemic” stroke is an injury to the brain caused by a blocked blood vessel supplying the brain.
Studying the Effect of Using Virtual Reality with Spinal Cord Stimulation to Manage Pain
This study is being to see if using virtual reality (VR) along with spinal cord stimulation can help better manage pain. Research has shown that using this type of “leg illumination” virtual reality reduces pain. We hope to further this research by identifying which sensory pathway (part of the nervous system that makes one aware of what one feels) causes pain to decrease. If the Virtual Realty acts through a different sensory pathway than a spinal cord stimulator, those with pain may have some additional pain relief.
This study will require 2 study visits; one will last approximately 1 hour, and the other visit will last about 5 hours throughout the day.
1. Age 18–and older at the time of enrollment
2. Individuals who are experiencing lower extremity pain e.g. neuropathy, Complex Regional Pain Syndromes (CRPS) type-1, neuropathic leg pain following Failed Back Surgery (FBS) etc.
3. Those who have an implanted epidural Spinal Cord Stimulator (SCS)
4. The SCS implantation for at least three months prior to enrollment
Movement and Music Study for Those with Dementia--Age 60 and Over
There is some evidence that music based interventions may have a protective effect on the brain in those with dementia. There is also evidence that doing activities that engage the brain through music are beneficial. This study seeks to investigate the potential benefits of a music based intervention for individuals with dementia.
You may be eligible if you:
- Have a diagnosis of dementia (mild to moderate)
- Are age 60 and older
- Able to follow simple instructions
-Unable to walk 10 feet unassisted
-Presence of bone disorder that impacts walking
-Presence of other neurologic diagnosis that impacts cognitive or motor function such as stroke, Parkinson disease or traumatic brain injury
Lewy Bodies Study for Those Experiencing Visual Hallucinations (VH)
Purpose: To assess the safety of using a drug called nelotanserin with those who have dementia with Lewy body with visual hallucinations.
--Diagnosis: dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD), presence of visual hallucinations that occur more days than not.
--MMSE Score: greater than or equal to 18 (Mini-Mental State Exam--Coordinator will explain)
--Must have a study partner willing to attend visits and ensure compliance with the study