Interventional Trials
An interventional trial is when researchers actively give participants a treatment (like a new drug, device, or therapy) and compare outcomes to see if it works and/or is safe; sometimes participants receive a placebo (a harmless look-alike with no active ingredient) so results can be measured fairly.
PARKINSON’S DISEASE INTERVENTIONAL TRIALS
Bemdaneprocel (Phase 3) (Neuronal-derived stem cell transplant in PD) | Principal Investigator: Schiess
Status: Active
hESC-derived midbrain dopaminergic neurons for PD treatment
Inclusion: PD Age 45-75, levodopa responsive, motor fluctuations >2.5h daily OFF, H&Y 2-3 OFF, MoCA >24.
Exclusion: Atypical parkinsonism, DBS, infusion therapy, chronic infections
Contact: Robert Ritter III, Research Assistant @ [email protected]
NeuLark (Phase 2) (LRRK2 inhibitor for genetic PD) | Principal Investigator: Mehanna
Status: Active
LRRK2 inhibitor
Key inclusion criteria: 1) PD patient aged 50-80 2) on no meds ideally, but MAO-I OK if stable for at least 30 days.
Contact: Brittany Duncan, Research Coordinator @ [email protected]
PRISMS (Phase 2) (adalimumab in iRBD)| Principal Investigator: Schiess
Status: Site activation, Recruiting soon
Adalimumab for neurodegeneration in iRBD
Inclusion: iRBD, age 50–80, UPSIT <15th, MoCA >23.
Exclusion: Prior diagnosis of a neurodegenerative disorder, active infection, or autoimmune disease
Contact: Robert Ritter III, Research Assistant @ [email protected]
ELEVATE-PD (Phase 4)(CREXONT: ER extended-release levodopa/carbidopa) | Principal Investigator: Schiess & Tharp
Status: Active, not recruiting
CREXONT, an extended-release levodopa/carbidopa, to improve “Good ON” time in Parkinson’s disease
Inclusion: PD, MDS-UPDRS OFF >20, Predictable OFF, ≥2.5 hrs/day OFF, Daily IR LD/CD 300–1200 mg.
Exclusion: DBS, CR CD-LD use (except bedtime), Duopa, Nonselective MAOI, Rescue meds (apomorphine, inhaled LD).
Contact: Robert Ritter III, Research Assistant @ [email protected]
Light PD (Phase 3) (daily use therapeutic light device) | Principal Investigator: Mehanna & Furr-Stimming
Status: Active, Not Recruiting
Light therapy on PD, conducted virtually from patient’s home.
Inclusion: PD aged ≥45, on dopaminergic drugs ≥1 year with good response, stable medication dose for 28 days.
If interested: patient needs to log on to https://www.lightforpd.com/
MSC-3 Clinical Trial (Phase 3) (Intravenous mesenchymal stem cells for PD) | Principal Investigator: Schiess
Status: Planning phase
Intravenous allogeneic bone marrow-derived MSCs as disease-modifying therapy in idiopathic PD. Mild-to-moderate PD.
Inclusion and exclusion: criteria not yet available
Contact: Robert Ritter III Research Assistant @ [email protected]
FMT-PD 2 (Phase 2) (fecal microbiome transplant for PD) | Principal Investigator: Schiess & DuPont
Status: Planning phase
FMT as a disease-modifying therapy for idiopathic PD. Mild-to-moderate PD.
Inclusion and exclusion: criteria not yet available Planning phase
Contact: Robert Ritter III Research Assistant @ [email protected]
HUNTINGTON’S DISEASE (HD) INTERVENTIONAL TRIALS
tDCS for HD (Transcranial stimulation) | Principal Investigator: Furr-Stimming
Status: Recruiting
Open-label trial assessing home-based transcranial direct current stimulation in early to mid HD over 8 weeks.
Inclusion: Age 18–80, confirmed HD, early–moderate stage (TFC 1–3), Mild–moderate behavioral symptoms (PBA-S ≤3, none = 4), Stable meds, Caregiver available
Exclusion: Unstable medical condition, Epilepsy history, Brain metal / implant, Major cognitive disorder / dementia, Suicidal risk
Contact: Thiago Macedo e Cordeiro, Postdoctoral Research Fellow @ [email protected] | Ali Zare Dehnavi, Postdoctoral Research Fellow @ [email protected]
Generation HD2 | Principal Investigator: Furr-Stimming
Status: Active, not recruiting
An RCT to Evaluate the safety, biomarkers, and efficacy of TOMINERSEN in individuals with prodromal and early manifest HD
Inclusion: Confirmed HD gene expansion (CAP 400-500), age 25-50 years, Prodromal (DCL 2–3) or early manifest HD (DCL 4), IS ≥70, TFC ≥8, eGFR ≥60, BMI 18–32
Exclusion: Suicidal risk, serious medical issues, HIV/ Prior ASO/HTT therapy, pregnancy/breastfeeding, CNS implant, drug/alcohol abuse.
Contact: Jamie Sims, Research Coordinator @ [email protected]
KINECT-HD2 (valbenazine) | Principal Investigator: Furr-Stimming & Hunter
Status: Active, not recruiting
Open-label rollover study continuing valbenazine in Huntington’s chorea; allows new patients after screening.
Inclusion: Confirmed HD, age 18-75 years, TMC score ≥8, TFC ≥5
Exclusion: pregnancy, serious heart/medical/psychiatric illness, severe dysphagia, or safety risks.
Contact: Christine Farrell, Research Coordinator @ [email protected]
uniQure (AMT-130) | Principal Investigator: Furr-Stimming
Status: Active, not recruiting
Trial to evaluate safety and tolerability of AMT-130 gene therapy in early manifest HD patients.
Inclusion: age 25–65, early manifest HD, HTT gene ≥40 CAG, striatal MRI volume (putamen ≥2.5, caudate ≥2.0 cm³), stable meds, negative pregnancy.
Exclusion: Suicide risk, implanted devices, prior HD gene/RNA/DNA therapy or brain surgery, MRI/LP contraindication, major neurologic/medical comorbidity, recent malignancy, serious infection.
Contact: Brittany Duncan, Research Coordinator @ [email protected]