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Promising new drug targets genetic Parkinson's in early trial

NCT ID NCT06602193

Disease control Sponsor: Denali Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called BIIB122 in 50 people who have a specific genetic form of Parkinson's disease (LRRK2-PD). The main goal is to check the drug's safety and how it affects certain markers in the blood and urine over 12 weeks. Participants are randomly assigned to receive either the drug or a placebo, and neither they nor the doctors know who gets which.

Why investors are watching

Denali Therapeutics is running a small Phase 2a trial of its drug BIIB122 in 50 people with a specific genetic form of Parkinson's disease caused by LRRK2 mutations. For a small company, this readout matters because it tests whether the drug safely changes disease-related markers in humans, a key step before larger studies. A clear result could validate Denali's approach and support its pipeline value.

If it works: A positive result could show that BIIB122 safely affects the intended biological pathway in patients, strengthening Denali's case for advancing the drug into later-stage trials. That outcome could also reinforce confidence in the company's broader neurology research platform.

If it fails: A failure or unclear result could delay the drug's development and hurt Denali's prospects, since early-stage trials often do not meet their goals. The company's value depends heavily on this and similar experimental programs, so a setback could be significant.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 8 movement disorder Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cedars-Sinai Department of Neurology

    Los Angeles, California, 90048, United States

  • Evergreen Health Laboratory

    Kirkland, Washington, 98034, United States

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital Universitari General de Catalunya

    Barcelona, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • IDIVAL/University Hospital Marques de Valdecilla

    Santander, Spain

  • Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center

    New York, New York, 10003, United States

  • Inland Northwest Research

    Spokane, Washington, 99202, United States

  • Movement Disorders Institute, Sheba Medical Center

    Ramat Gan, Israel

  • Parkinson's Disease and Movement Disorders Center

    Boca Raton, Florida, 33486, United States

  • Rabin Medical Center

    Petah Tikva, Israel

  • Technische Universität Dresden

    Dresden, Germany

  • Tel Aviv Medical Center

    Tel Aviv, Israel

  • Universitary Hospital La Princesa

    Madrid, Spain

  • University Hospital Tübingen

    Tübingen, Germany

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • University of Lübeck

    Lübeck, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.