Join a Study

exPDite-2 is a double-blind, simulated surgery-controlled phase 3 study evaluating the potential efficacy and safety of bemdaneprocel, a cell therapy designed to potentially replace the dopamine-producing neurons that are lost in Parkinson’s disease with the aim of engrafting into the brain to restore dopaminergic function.

Inclusion criteria:

•     PD Diagnosed 4-12 years ago in participants age 45-75

•     Robust and clear response to dopaminergic therapy as defined by a decrease in MDS-UPDRS Part III score of ≥30% from the off-medication state to the on-medication state

•     oral levodopa-based regimen with a dosing frequency of ≥3 times per day, and no change in the prescribed dose and frequency for ≥4 weeks prior to screening

•     ≥2.5 hours of daily OFF-time

•     Hoehn and Yahr stage of 2 to 3 in the off-medication state

•     Score of ≥30 on MDS-UPDRS Part III in the off-medication state

•     Montreal Cognitive Assessment (MoCA) score of ≥24

Exclusion criteria:

•     PD presenting with recurrent falls, defined as ≥3 incidents of a fall over the 12 months prior

•     Prior treatment with intrajejunal or subcutaneous infusion therapies for PD

•     Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery

Contact: Frank Ferrari [email protected]  or Angela Stovall [email protected]

Objective: Advance our understanding of progressive cholinergic changes within specific subcortical and cortical structures subserving cognitive and attentional-motor integration functions in PwP at risk of dementia, balance and gait disturbances.

Inclusion Criteria:

• Age 45 and above (M/F).
• PD diagnosis (with or without Mild Cognitive Impairment)
• All PD subjects are required to have nigrostriatal dopaminergic denervation as demonstrated by PET scan.

Exclusion Criteria:

• Presence of clinically significant dementia.
• Disorders which may resemble PD, such as dementia with Lewy bodies, vascu­lar dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic dege­neration, or toxic causes of parkinsonism.
• Subjects on neuroleptic, anticholinergic (trihexiphenidyl, benztropine), or cholinesterase inhibitor drugs.
• Evidence of a large vessel stroke in a clinically relevant area (cerebral cortex, basal ganglia, thalamus) or mass lesion on structural brain imaging (MRI or CT).
• Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
• Severe claustrophobia precluding MR or PET imaging.
• Subjects limited by previous participation in research procedures involving ionizing radiation.
• Pregnancy (test within 48 hours of each PET session) or breastfeeding.
• History of deep brain stimulation surgery.
• Suicidality 

Coordinator: Hegres Al-Jubury  hegres@umich.edu

Objective: Mapping the Future of Parkinson’s Disease is a Parkinson’s Foundation initiative that offers genetic testing and genetic counseling at no cost for people with Parkinson’s disease (PD). Genetic testing includes a minimum of seven specific PD genes (LRRK2, GBA1, SNCA, PRKN, PARK 7, PINK1, VPS35). Participants may choose to also receive additional findings which might be related to their PD diagnosis and/or health-related clinically actionable findings. Participants will be asked to complete a short questionnaire and provide a blood sample. Results are provided in a genetic counseling session.

Inclusion criteria:

•     At least 18 years old.

•     Capacity to give full informed consent or provide consent through a legally authorized representative (LAR).

•     Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson’s disease: probable diagnosis based on Investigator discretion.

•     Willingness to undergo genetic testing and receive genetic test results for at minimum seven Parkinsons-related genes.

Exclusion criteria:

•     Probable diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.

•     Individuals who have received a blood transfusion within the past 3 months.

•     Individuals who have active hematologic malignancies such as lymphoma or leukemia.

•     Individuals who have had a bone marrow transplant within the past 5 years.

Contact: Teresa Scerbak [email protected]

Objective: This study will examine the potential of CVN424 (a GPR6 inverse agonist) to decrease off time in patients with Parkinson’s Disease with motor complications. Participants will be randomized to receive either 75 mg or 150 mg CVN424 once daily or matching placebo for 12 weeks. Participants will be asked to attend 7 study visits (including screening and follow up) over ~20 weeks.  

Key Inclusion Criteria:

• At least 30 years of age at the time of Screening

• Diagnosis of PD consistent with UK Brain Bank criteria and MDS Research Criteria for the Diagnosis of PD; must include bradykinesia with sequence effect and motor asymmetry if no rest tremor, and a prominent response to levodopa

• BMI > 18.0 and < 35.0 kg/m2 at Screening

• Modified Hoehn and Yahr Stage = 3 in the ON state

• Freely ambulatory at the time of Screening (with/without assistive device)

• Montreal Cognitive Assessment (MoCA) Score of at least 24

• Levodopa administration at least 4 times daily (immediate or controlled release C/L) or three times daily (Rytary or Crexont)

• Average of = 3 h total OFF time/day with at least 2.5 hours OFF on each day

Key Exclusion Criteria:

• Diagnosis of secondary or atypical parkinsonism

• Severe or disabling dyskinesias or OFF expected to preclude successful study participation

• Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (ie, Duopa, apomorphine, subcutaneous levodopa) , surgery for PD (ie, DBS), or anticipation of these during the study

• Routine use of PD on-demand medications (ie, inhaled levodopa, apomorphine injection)

• Routine use defined as three (3) or more uses per week of on-demand medication is not allowed. On-demand medications should only be used for medical emergencies and should be avoided on anticipated diary days, as best as possible.

• History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia

• Clinically significant orthostatic hypotension (consistently symptomatic or requiring medication)

• Clinically significant hallucinations requiring antipsychotic use

• Current use of strong CYP3A4/5 inhibitors or inducers and strong P-gp inhibitors

• Current use of medication with dopamine antagonist activity, or any use within the 12 months prior to Screening

Coordinator: Teresa Scerbak [email protected]; Cate Cochren  [email protected]

The CRANE Study (PIs: Albin/Kotagal; HUM00254213)

This is an NIH/NINDS-sponsored double-blind placebo-controlled randomized trial of varenicline (0.5mg by mouth twice daily) vs. placebo in individuals with PD-MCI to determine whether varenicline can reduce fall risk. Participants will undergo detailed clinical, neuropsychological, and imaging tests to determine eligibility. Enrolled participants will be on blinded study drug vs. placebo for 1 year, will complete a regular fall diary, and will check in with the study team by phone or in person about every 2 months.

Inclusion

Age >45 years

PD-MCI on study-assessed neuropsychological testing at baseline

Reduced cortical cholinergic integrity on study FEOBV PET imaging at baseline

Exclusion

Participants taking cholinesterase inhibitors at the time of baseline visit

Participants with modified Hoehn and Yahr scales of  ³4

Participants with contraindication to neuroimaging including MRI and PET

Please contact Dawn Keys [email protected] lead study coordinator) with information about potentially interested participants.

Objective: to continue to obtain information from people with and without Parkinson disease so that researchers may better understand how PD progresses, in order to inform better treatments.  Study procedures include DaTscan, MRI, Lumbar puncture and skin biopsy. 

The PD Cohort of PPMI is now closed. We are still enrolling Healthy Controls and those who have been diagnosed with REM Behavior Sleep Disorder.

Inclusion Criteria:

• 30+ years old for Healthy Controls, 60+ years old for RBD patients
• Must be willing and medically able to hold the following medications for at least 5 half-lives before dopamine imaging: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil.
• Confirmation that participant is eligible based on Smell Identification Test (UPSIT)
• Confirmation that participant is eligible based on Screening DaTscan imaging

Exclusion:

• Clinical diagnosis of PD at screening, other parkinsonism, or dementia
• Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Screening visit.
• Received any of the following drugs: dopamine receptor blockers, metoclopramide and reserpine within 6 months of Screening visit.
• Current or active clinically significant neurological disorder (in the opinion of the Investigator).  
• Previously obtained MRI scan with evidence of clinically significant neurological disorder
• Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture.

Coordinators: Frank Ferrari [email protected]; Kim Duval [email protected]; Angela Stovall [email protected]

Objective: to learn more about the effects of aerobic exercise on people with Parkinson’s disease who have not yet started medication for their PD. It will compare the effects of moderate intensity (60-65% HRmax) treadmill exercise to high intensity (80-85% HRmax) treadmill exercise on the signs and symptoms of Parkinson’s disease.

Inclusion criteria:

• Primary Parkinson’s Disease diagnosed using UK Brain Bank Criteria (< 3 years since diagnosis)
• Age 40-80 years
• Hoehn and Yahr stage less than 3

Exclusion criteria:

• Currently treated with dopaminergic therapies or expected to require such treatment within next 6 months
• Use of PD medication within past 60 days
• Poorly controlled or unstable cardiovascular, metabolic, or renal disease
• Hypertension, hypo- or hyperthyroidism, and/or abnormal renal function. Orthostatic hypotension & standing systolic BP < 100
• Disorders that interfere with ability to perform endurance exercises
• >120 minutes/week moderate intensity endurance exercise for more than 6 months
• MoCA score <26, BDI score >16
• Prior SPECT scan within past 6 months
• Allergy to iodinated products/hypersensitivity to DaTscan™ SPECT
• Women who are pregnant or plan to become pregnant in next 12 months

Coordinator: Jake Fogel [email protected]

Objective: To better understand differences in whole-brain cholinergic activity between LRRK2-PD and iPD, and how those differences may contribute to motor and cognitive symptom expression.

 Inclusion Criteria:

1.    Male or Female, age 45 years and over.

2.    Diagnosis of PD

3.    Presence of LRRK2 mutation

 Exclusion Criteria:

1.    Evidence of atypical parkinsonism

2.    Contra-indications to MR

3.    Evidence of large vessel stroke or mass lesion on MRI.

4.    Regular use of typical anti-cholinergic drugs or cholinesterase inhibitors

5.    History of deep brain stimulation surgery

6.    Pregnant or nursing

7.    Suicidal ideation

Coordinator: Rob Vangel [email protected]

Objective: To perform a double-blinded, randomized, placebo-controlled phase 2 clinical trial of 500 mg tributyrin tid po for 90 days and investigate clinical effects on cognition, motor functions, and clinical safety in people with PD-MCI or PDD

Inclusion Criteria:

1. Male or Female, age 45 years and over.
2. Diagnosis of PD-MCI or PDD 

Exclusion Criteria:

1.    Evidence of atypical Parkinsonism
2.    Contra-indications to MR
3.    Evidence of large vessel stroke or mass lesion on MRI.
4.    Regular use of typical anti-cholinergic drugs
5.    Recent history of significant GI disease such as GERD or colorectal cancer
6.    Significant metabolic or uncontrolled medical comorbidity
7.    Pregnant or nursing
8.    Suicidal ideation

Coordinator: Rob Vangel [email protected]

Objective: Worldwide longitudinal observational study of Huntington’s disease (HD) whose overarching goal is to accelerate progress towards the development of effective therapeutics for HD

Inclusion Criteria:

• Carriers:
  • Individuals who carry the HD gene expansion mutation (stage 1 and 2 only)
• Controls:
  • Individuals who do not carry the HD expansion mutation
    • First or second degree relatives to a carrier;
    • Family members or individuals not related by blood to carriers (e.g. spouses, caregivers); or
    • Community controls, which are individuals unrelated to HD carriers who did not grow up in a family affected by HD

Exclusion Criteria:

• Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation
• For community controls: individuals with a major central nervous system disorder (e.g. stroke, Parkinson’s disease, Multiple Sclerosis, etc.)

Coordinator: [email protected]