Neurological

Official Title

A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, 27-WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)

Purpose

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.

Could this study be right for you?

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.

Age Range

40 and up

Official Title

A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients

Purpose

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.

Could this study be right for you?

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

Age Range

30 and up

Official Title

Decision-Making Abilities and Testamentary Capacity Among Older Adults

Purpose

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.

Could this study be right for you?

Inclusion Criteria:
-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

Exclusion Criteria:

- A history of psychiatric illness necessitating inpatient treatment
- Participants with self-reported depression and/or anxiety exceeding mild levels of clinical severity

Age Range

65 and up

Official Title

Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy for Tremor Surgery

Purpose

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.

Could this study be right for you?

- You must be between the ages of 40 and 85
- Willing to have MRI imaging of the brain

Age Range

40 and up

Official Title

DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping Phase II

Purpose

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.

Could this study be right for you?

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

Exclusion Criteria

* You are currently participating in any study with an investigational medicinal product (IMP) or investigational device.

Age Range

18 and up

Official Title

AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke (ARCADIA)

Purpose

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.

Could this study be right for you?

- 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.

Age Range

45 and up

Official Title

Movement and Music Intervention for Individuals with Dementia

Purpose

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.

Could this study be right for you?

You may be eligible if you:
- Have a diagnosis of dementia (mild to moderate)
- Are age 60 and older
- Able to follow simple instructions

EXCLUSION CRITERIA:
-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

Age Range

60 and up

Official Title

A Phase 2, double-blind, randomized, placebo-controlled cross-over study of nelotanserin versus placebo in Lewy body dementia (LBD) subjects experiencing visual hallucinations (VH)

Purpose

Purpose: To assess the safety of using a drug called nelotanserin with those who have dementia with Lewy body with visual hallucinations.

Could this study be right for you?

--Age: 50-85
--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

Age Range

50 and up

Official Title

A Phase 2, double-blind, randomized, placebo-controlled study of nelotanserin versus placebo in patients with dementia with Lewy bodies (DLB) experiencing REM sleep behaviors (RBD)

Purpose

The purpose of this study is to evaluate the safety of the study drug called nelotanserin and to assess the effects of nelotanserin in those experiencing frequent REM sleep behavior disorders due to dementia with Lewy bodies. Nelotanserin (study drug) is an investigational product, which means that it has not been approved by the U.S. Food and Drug Administration (FDA) or the government health agencies of any other countries.

Could this study be right for you?

--Age: 50-85
--Diagnosis: probable dementia with Lewy bodies or Parkinson's disease dementia
--AND diagnosis of REM sleep behavior disorder (RBD) with frequent RBD episodes
--Must have a study partner willing to serve as a collateral informant for study assessments
--MMSE Score: greater than or equal to 18 (Mini Mental State Examination score to be explained by the coordinator)

Age Range

50 and up

Official Title

A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB)

Purpose

Purpose of Study:
This research study is being done to test a drug called RVT-101. Our researchers want to assess the effects of RVT-101 versus placebo on function including attention, working memory, reaction time, as well as other measures of cognition in patients with DLB.
RVT-101 is an investigational drug. Investigational means that the drug tested in this study has not been approved by the U.S. Food and Drug Administration (FDA) or any other Health Authority including European or Canadian Health Authorities.

Could this study be right for you?

--Ages 50-85
--Diagnosis of Probable dementia with Lewy bodies
--Must have a study partner willing to attend visits and ensure compliance with the study
--Score on MMSE of 14-26 (Mini–Mental State Examination--the study coordinator can explain this)

Age Range

50 and up