50 Participants Needed

BIIB122 for Parkinson's Disease

Recruiting at 14 trial locations
CT
Overseen ByClinical Trials at Denali Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Denali Therapeutics Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

How does the drug BIIB122 differ from other Parkinson's disease treatments?

BIIB122 (DNL151) is unique because it targets the FBXO7 protein, which is involved in maintaining brain neurons and is linked to the pathogenesis of Parkinson's disease. This approach is different from traditional treatments that primarily focus on managing symptoms rather than addressing underlying cellular mechanisms.12345

Who Is on the Research Team?

DJ

Danna Jennings, MD

Principal Investigator

Denali Therapeutics

Are You a Good Fit for This Trial?

This trial is for people aged 30-80 with Parkinson's Disease who carry a specific genetic change (LRRK2 variant) that increases LRRK2 activity. They must meet the clinical criteria for PD diagnosis and have verified genetic test results showing they have this mutation.

Inclusion Criteria

I am between 30 and 80 years old with a specific genetic mutation.
I am 30 years or older with a specific genetic mutation.
My genetic test shows I have a LRRK2 mutation.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BIIB122 225 mg or a matching placebo once daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

What Are the Treatments Tested in This Trial?

Interventions

  • BIIB122
Trial Overview The study tests BIIB122, a potential new treatment for Parkinson's Disease, against a placebo. Participants are randomly assigned to receive either BIIB122 or a fake pill without active ingredients, in order to compare effects over 12 weeks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BIIB122 225 mgExperimental Treatment1 Intervention
Group II: BIIB122 Matching PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Denali Therapeutics Inc.

Lead Sponsor

Trials
24
Recruited
1,900+

Biogen

Industry Sponsor

Trials
655
Recruited
468,000+
Daniel Quirk profile image

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher profile image

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Published Research Related to This Trial

Mutations in the FBXO7 gene lead to PARK15, a neurodegenerative disease characterized by severe parkinsonism, and the depletion of the FBXO7 isoform 1 in patients suggests its crucial role in maintaining brain neurons.
The study found that the normal FBXO7 isoform 1 is primarily localized in the nucleus of neurons, and its mislocalization or instability due to mutations may contribute to the disease's pathogenesis.
Loss of nuclear activity of the FBXO7 protein in patients with parkinsonian-pyramidal syndrome (PARK15).Zhao, T., De Graaff, E., Breedveld, GJ., et al.[2021]
Mutations in the FBXO7 gene are linked to PARK15, a form of juvenile parkinsonism, and this study found that FBXO7 protein is widely expressed in the brain, particularly in neurons of the cerebral cortex, putamen, and cerebellum.
FBXO7 was found to colocalize with α-synuclein in Lewy bodies and other inclusions in Parkinson's disease and multiple system atrophy, suggesting that FBXO7 may play a significant role in the development of these synuclein-related neurodegenerative diseases.
FBXO7 immunoreactivity in α-synuclein-containing inclusions in Parkinson disease and multiple system atrophy.Zhao, T., Severijnen, LA., van der Weiden, M., et al.[2013]
A new Turkish family was identified with a homozygous mutation in the FBXO7 gene, which is linked to juvenile parkinsonism, highlighting the genetic diversity of this condition.
Affected siblings showed progressive parkinsonism and mental retardation, with a limited response to dopaminergic medications due to side effects, indicating the complexity of treatment in this genetic form of parkinsonism.
A new Turkish family with homozygous FBXO7 truncating mutation and juvenile atypical parkinsonism.Yalcin-Cakmakli, G., Olgiati, S., Quadri, M., et al.[2014]

Citations

Loss of nuclear activity of the FBXO7 protein in patients with parkinsonian-pyramidal syndrome (PARK15). [2021]
FBXO7 immunoreactivity in α-synuclein-containing inclusions in Parkinson disease and multiple system atrophy. [2013]
A new Turkish family with homozygous FBXO7 truncating mutation and juvenile atypical parkinsonism. [2014]
Ser129D mutant alpha-synuclein induces earlier motor dysfunction while S129A results in distinctive pathology in a rat model of Parkinson's disease. [2013]
The loss of inhibitory C-terminal conformations in disease associated P123H β-synuclein. [2018]
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