A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson’s Disease (NEULARK)
Principal Investigator: Sotirios Parashos, MD, PhD
Study sponsor: Neuron23, Inc.
Location: Struthers Parkinson’s Center
Phase of Study: II
Purpose of study: This is a randomized, placebo-controlled, study in participants with early PD who have elevated leucine-rich repeat kinase 2 (LRRK2)-pathway activity assessed using a co-developed investigational CDx. Only participants who test positive using the investigational CDx will be included in the study, including both individuals with rare variants and others with predicted elevations in LRRK2 activity. The study will evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of orally administered NEU-411, a study drug as compared to placebo.
Inclusion Criteria:
– The participant must test positive (LRRK2-driven) using the investigational CDx performed at the designated central laboratory
– Aged 50-80 years at time of Screening
– Participants are not currently on nor anticipated to require dopaminergic therapy (e.g., levodopa) within the next 12 months
– Participants who have a body mass index (BMI) of 18-32 kg/m2
Exclusion Criteria:
– Parkinsonian syndromes due to a secondary etiology, including parkinsonism from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive supranuclear palsy, Lewy body (LB) dementia
– Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%
– Reside in a skilled nursing facility
Study Contact:
Carrie Weaver
(651) 495-6363
ClinicalTrials@HealthPartners.com
Continuous wearable monitor for the detection and release of freezing of gait
Principal Investigator: Martha Nance, MD
Study sponsor: National Institute on Aging
Location: Center for Memory and Aging, Neuroscience Center, Struthers Parkinson’s Center
Phase of Study: I
Purpose of study: The purpose of the study is to test an insole and cueing device and determine whether it can reduce the number and length of FOG events in people living with PD. If you choose to participate, you will have an initial phone screening to evaluate your eligibility for the study, followed by two in-person visits and weekly phone calls over 5 weeks. You will also be given the insole device to take home and use within your home and the community for 5 weeks. Your participation will take approximately 7 weeks total, depending on when the in-person visits are scheduled.
Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
-Ability to provide and provision of signed and dated informed consent form.
-Age 45-80
-Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
-Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and NFOG-Q.
-Able to complete a 2-minute walk test at the pre-treatment visit.
-Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study.
-Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
-Non-English speaking
-History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.
-Other significant neurological disorders that may affect participation or performance in the study.
-Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
-Hallucinations
-Non-ambulatory
-Legally Blind
-Symptomatic hypotension
Study Contact:
Clarissa Howe
(651) 495-6368
Clarissa.M.Howe@HealthPartners.com
Parkinson’s Foundation PD GENEration Genetic Registry
Principal Investigator: Martha Nance, MD
Study sponsor: Parkinson’s Foundation
Location: Struthers Parkinson’s Center
Purpose of study: Purpose: to help improve our understanding of Parkinson’s Disease and help participants and their clinicians understand their genetic status to improve care, which includes determining eligibility for clinical trial participation. Study includes a baseline visit (in-person or by video) and a genetic counseling visit (by video, phone, or in-person) to discuss your test results with the study doctor.
Inclusion Criteria:
– Diagnosis, or probable diagnosis, for Parkinson’s Disease.
– Capacity to give full informed consent.
– Participant must have residential address in MN or Wisconsin.
Exclusion Criteria:
– Received a blood transfusion within the past 3 months.
– Received a bone marrow transplant within the past 5 years.
– Active blood cancer, such as lymphoma or leukemia.
– Under the age of 18.
Study Contact
Taylor Billeadeau
(651) 495-6363
ClinicalTrials@HealthPartners.com
For more information, please visit the study’s clinicaltirals.gov site at:
https://clinicaltrials.gov/study/NCT04994015
