--- title: New medication slows disease progression nct_id: NCT06602193 phase: PHASE2 status: RECRUITING sponsor: Denali Therapeutics Inc. study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT06602193" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06602193" last_fetched: "2026-05-10T14:03:53.116Z" source: "Parkinson's Pathways (curated)" --- # New medication slows disease progression **Goal (in five words):** New medication slows disease progression **Official Title:** A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) **Trial ID:** [NCT06602193](https://clinicaltrials.gov/study/NCT06602193) ## Key Facts - **Phase:** PHASE2 - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** Denali Therapeutics Inc. - **Target Enrollment:** 50 participants - **Start Date:** 2024-10-24 - **Completion Date:** 2026-04-30 - **Conditions:** Parkinson Disease - **Interventions:** BIIB122 225 mg, BIIB122-Matching Placebo - **Intervention Types:** DRUG, OTHER ## Summary For Families The goal is to see whether BIIB122 can safely dial down overactive LRRK2 kinase activity, the molecular driver of cell stress in people with LRRK2-linked Parkinson's, and produce pharmacodynamic changes that suggest it might slow harmful disease processes. BIIB122 is an oral LRRK2 inhibitor designed to lower that enzyme’s activity in the body, it is being tested alongside participants' usual Parkinson's medicines rather than replacing levodopa, and the study carefully watches safety and any effects on standard treatments. They plan to enroll about 50 adults with genetically confirmed pathogenic LRRK2 variants who meet clinical Parkinson's criteria, generally ages 30 to 80 for heterozygous carriers and 30 or older for homozygous carriers, excluding people with other major neurological disorders, prior PD gene therapy or brain surgery, or serious lung or vital-sign abnormalities. ## Eligibility - **Minimum age:** 30 Years - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: * For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years * For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years * Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant. * Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria. Exclusion Criteria: * Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit. * Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism. * Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201). * Have previously participated or are currently participating in a gene therapy study for PD. * Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy). * Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability). * Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature * Have abnormal PFT results at screening Note: Other protocol defined Inclusion/Exclusion criteria may apply ``` ## Locations (20) - Cedars-Sinai Department of Neurology, Los Angeles, California, United States _(34.0522, -118.2437)_ - Anne Tran — (CONTACT) — 310-423-1697 — anne.tran@cshs.org - Michele Tagliati, MD — (PRINCIPAL_INVESTIGATOR) - University of California San Francisco, San Francisco, California, United States _(37.7749, -122.4194)_ - Luisa Bolo Dave — (CONTACT) — Luisa.Bolodave@ucsf.edu - Marta San Luciano Palenzuela, MD — (PRINCIPAL_INVESTIGATOR) - Parkinson's Disease and Movement Disorders Center, Boca Raton, Florida, United States _(26.3587, -80.0831)_ - Stuart Isaacson, MD — (CONTACT) — 561-392-1818 — info@ParkinsonsCenter.org - Stuart Isaacson, MD — (PRINCIPAL_INVESTIGATOR) - Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States _(42.3584, -71.0598)_ - Jackie Forbes — (CONTACT) — 617-667-9885 — jforbes1@bidmc.harvard.edu - Ludy Shih, MD — (PRINCIPAL_INVESTIGATOR) - Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center, New York, New York, United States _(40.7143, -74.0060)_ - Ricardo Renvill — (CONTACT) — 212-844-6055 — Ricardo.Renvill@mountsinai.org - Matthew Swan, MD — (PRINCIPAL_INVESTIGATOR) - Evergreen Health Laboratory, Kirkland, Washington, United States _(47.6815, -122.2087)_ - EvergreenHealth Research Department — (CONTACT) — EvergreenResearch@evergreenhealthcare.org - Pinky Agarwal, MD — (PRINCIPAL_INVESTIGATOR) - Inland Northwest Research, Spokane, Washington, United States _(47.6597, -117.4291)_ - Jason Aldred, MD — (CONTACT) — 509-960-2818 — jaldred@selkirkneurology.com - Jason Aldred, MD — (PRINCIPAL_INVESTIGATOR) - Technische Universität Dresden, Dresden, Germany _(51.0509, 13.7383)_ - Marian Kollaske — (CONTACT) — Marian.Kollaske@ukdd.de - Björn Falkenburger, MD — (PRINCIPAL_INVESTIGATOR) - University of Lübeck, Lübeck, Germany _(53.8689, 10.6873)_ - Madita Grümmer — (CONTACT) — madita.gruemmer@uni-luebeck.de - Norbert Brüggemann, MD — (PRINCIPAL_INVESTIGATOR) - University Hospital Tübingen, Tübingen, Germany _(48.5227, 9.0522)_ - Susanne Solbrig — (CONTACT) — Susanne.Solbrig@med.uni-tuebingen.de - Thomas Gasser, MD — (PRINCIPAL_INVESTIGATOR) - Rabin Medical Center, Petah Tikva, Israel _(32.0871, 34.8875)_ - Dana Vhava — (CONTACT) — danavh@clalit.org.il - Ruth Djaldetti, MD — (PRINCIPAL_INVESTIGATOR) - Movement Disorders Institute, Sheba Medical Center, Ramat Gan, Israel _(32.0823, 34.8107)_ - Adi Saar — (CONTACT) — adi.saar@sheba.health.gov.il - Sharon Hassin, MD — (PRINCIPAL_INVESTIGATOR) - Tel Aviv Medical Center, Tel Aviv, Israel _(32.0809, 34.7806)_ - Adi Ezra — (CONTACT) — adil@tlvmc.gov.il - Tanya Gurevich, MD — (PRINCIPAL_INVESTIGATOR) - Hospital Clinic de Barcelona, Barcelona, Spain _(41.3888, 2.1590)_ - Pilar Santacruz — (CONTACT) — PSANTA@clinic.cat - Alicia Garrido, MD — (PRINCIPAL_INVESTIGATOR) - Hospital Universitari General de Catalunya, Barcelona, Spain _(41.3888, 2.1590)_ - Susana Andrade — (CONTACT) — +3493175715 — s.andrade@udic.es - Ernest Balaguer Martínez, MD — (PRINCIPAL_INVESTIGATOR) - Hospital Universitari Vall d'Hebron, Barcelona, Spain _(41.3888, 2.1590)_ - Alejandra Garcia Blanco — (CONTACT) — alejandra.garcia@vhir.org - Jorge Hernandez-Vara, MD — (PRINCIPAL_INVESTIGATOR) - Hospital Universitario Donostia, Donostia / San Sebastian, Spain _(43.3128, -1.9750)_ - Ioana Croitoru — (CONTACT) — ioana.croitoru@bio-gipuzkoa.eus - Javier Ruiz Martinez, MD — (PRINCIPAL_INVESTIGATOR) - Universitary Hospital La Princesa, Madrid, Spain _(40.4165, -3.7026)_ - Pablo Sáinz-Ezquerra — (CONTACT) — p.sainzezquerra@gmail.com - Lydia Lopez-Manzares, MD — (PRINCIPAL_INVESTIGATOR) - IDIVAL/University Hospital Marques de Valdecilla, Santander, Spain _(43.4659, -3.8049)_ - Raquel Martinez — (CONTACT) — raquel.martinez@scsalud.es - Jon Infante, MD — (PRINCIPAL_INVESTIGATOR) - Hospital Universitario Virgen del Rocio, Seville, Spain _(37.3828, -5.9732)_ - Cristina Gomez Rapela — (CONTACT) — cgomez-ibis@us.es - Lorena Garrote — (CONTACT) — lgarrote-ibis@us.es - Pablo Mir Rivera, MD — (PRINCIPAL_INVESTIGATOR) ## Central Contacts - Clinical Trials at Denali Therapeutics — (CONTACT) — clinical-trials@dnli.com --- *Canonical: https://parkinsonspathways.com/trial/NCT06602193* *HTML version: https://parkinsonspathways.com/trial/NCT06602193* *Source data: https://clinicaltrials.gov/study/NCT06602193*