Shyamal H. Mehta, M.D., Ph.D.

The purpose of this study is twofold:

Specific Aim 1

• In biopsies of skin from living subjects with DLB, PD without dementia (PD), and PD with dementia (PDD), assess the relative diagnostic sensitivity and specificity of IHC and seeding assay measures of aSyn, relative to normal control subjects.

Specific Aim 2

• In second biopsies of skin from subjects with DLB, PD and PDD, assess whether IHC and seeding measures of aSyn progress, regress or remain stable over time, indicating whether these may be useful as measures of therapeutic agent target engagement and disease progression.

The purpose of this study is to develop an innovative smartphone interface system using a novel real-time video processing approach that allows users with hand tremor to effectively control apps and input data. The Mayo Clinic will establish the usability and acceptability of the system for persons with tremors through human subjects testing.

The Parkinson Progression Marker Initiative (PPMI) is a study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson’s disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

The purpose of this study is to evaluate the safety of intracisternal LY3884961 administration in patients with moderate to severe Parkinson's disease with at least 1 pathogenic GBA1 mutation. 

Determine 1) the magnitude of SMG and skin a-syn density change over time, 2) the

improvement in adequate tissue acquisition doing bilateral SMG biopsies, 3) any laterality differences between

SMG gland a-syn density, 4) correlate a-syn density and changes in density between SMG and skin biopsies

Specific Aim 1. Determine, with bilateral submandibular gland (SMG) biopsies in 30 clinically

diagnosed subjects with Parkinson’s disease (PD) and 20 clinically probable REM sleep behavior

disorder (RBD) subjects whether bilateral biopsies improve the rate of acquisition of adequate

glandular tissue, whether alpha-synuclein (a-syn) SMG pathology correlates with clinical severity

and/or disease duration, and whether there is a left-right difference in the density of a-syn pathology.

Specific Aim 2. Determine, with a second SMG biopsy in previously biopsied PD and RBD subjects,

whether a-syn pathology density increases, decreases, or remains the same after a 1.5-2 year time

interval and whether there is a correlation between a-syn SMG pathology and clinical and/or disease

progression.

Specific Aim 3. Determine whether a-syn pathology density in skin punch biopsies correlates

with clinical measures and increases, decreases, or remains the same after a 1.5-2 year time

interval, and whether the density and changes over time correlate with those found in SMG

biopsies.

This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. This will serve as an extension to the CVT-301-004 study for those patients who participated in that study and remain eligible for this study. In addition, patients who previously completed the CVT-301-003 study as well as additional CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.

This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.

The purpose of this study is to assess the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea (excessive saliva flow).

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study .

The purpose of this study is to determine the effectiveness, safety and tolerability of APL-130277 to treat acute motor fluctuation episodes in levodopa responsive patients with Parkinson's disease.

A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.

The purpose of this study is to determine whether oral inosine dosed to moderately elevate serum urate (from ≤5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early Parkinson's disease.

A  study in L-Dopa responsive parkinson's disease patients with motor fluctuations ("OFF" episodes), designed to evaluate the long-term safety, tolerability and effectiveness of APL-130277.

The purpose of this study is twofold:

Specific Aim 1

• In biopsies of skin from living subjects with DLB, PD without dementia (PD), and PD with dementia (PDD), assess the relative diagnostic sensitivity and specificity of IHC and seeding assay measures of aSyn, relative to normal control subjects.

Specific Aim 2

• In second biopsies of skin from subjects with DLB, PD and PDD, assess whether IHC and seeding measures of aSyn progress, regress or remain stable over time, indicating whether these may be useful as measures of therapeutic agent target engagement and disease progression.

A randomized placebo-controlled trial in individuals with Parkinson's disease dementia to evaluate the safety and efficacy of three doses of study drug LY3154207 in participants with mild-to-moderate Parkinson's disease dementia treated for 12 weeks.

This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance. In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.

Primary Objectives: - Part 1: To determine the safety and tolerability of GZ/SAR402671 administered orally, as compared to placebo in patients with early-stage Parkinson's disease (PD) carrying a GBA mutation or other pre-specified variants. - Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in patients with early-stage Parkinson's disease carrying a GBA mutation or other pre-specified variants. Secondary Objectives: Part 1: - To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR4027671 in plasma when administered in early-stage Parkinson's disease patients carrying a GBA mutation. - To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in early-stage Parkinson's disease patients carrying a GBA mutation. Part 2: - To demonstrate overall safety and tolerability of GZ/SAR4027671 administered orally in early-stage Parkinson's disease patients carrying a GBA mutation as compared to placebo. - To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage Parkinson's disease patients carrying a GBA mutation.

The purpose of this study is to assess the safety, tolerability, and effectiveness of NLY01 in subjects with early untreated Parkinson's Disease (PD) and collect data on the effect of the drug on antibody testing (DaT).

This is a 52-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).