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Pd01B

A groundbreaking clinical trial is underway to assess the potential of PD01B, a novel vaccine developed for patients with early-stage Parkinson’s disease. This Phase 2 study aims to investigate the safety, tolerability, and effectiveness of PD01B in slowing the progression of this neurodegenerative disorder. The trial involves multiple centers and employs a double-blind, randomized, and placebo-controlled approach to ensure reliable results.

Table of Contents

What is PD01B?

PD01B, also known as ACI-7104.056, is a new experimental treatment being developed for people with early-stage Parkinson’s disease[1]. It is a type of medicine called a vaccine, but unlike vaccines that prevent diseases, PD01B is designed to treat an existing condition[1].

How Does PD01B Work?

PD01B targets a protein in the brain called alpha-synuclein. In Parkinson’s disease, this protein can clump together and cause problems for brain cells[1]. The vaccine is designed to help the body’s immune system recognize and potentially reduce these harmful protein clumps[1].

Current Research on PD01B

Scientists are currently conducting a Phase 2 clinical trial to study PD01B[1]. This research aims to:

  • Check if PD01B is safe and well-tolerated by patients[1]
  • See how the body’s immune system responds to the vaccine[1]
  • Measure the effect of PD01B on alpha-synuclein levels in the blood and spinal fluid[1]
  • Examine changes in brain scans (called DaT-SPECT) that show Parkinson’s disease activity[1]
  • Assess if PD01B improves movement symptoms using a standard Parkinson’s rating scale[1]

Who Can Participate in the PD01B Study?

The study is looking for people who:

  • Have been diagnosed with early-stage Parkinson’s disease within the last 2 years[1]
  • Are between 40 and 75 years old[1]
  • Are taking a stable dose of levodopa (a common Parkinson’s medication)[1]
  • Have mild symptoms (Hoehn-Yahr Stage I to II, which means symptoms on one or both sides of the body but still good balance)[1]

There are also several factors that would prevent someone from participating, such as having other neurological conditions or a history of certain medical issues[1].

Study Details

The study is designed as follows:

  • Participants will receive either PD01B or a placebo (a harmless substance with no active ingredients)[1]
  • The vaccine is given as an injection into the muscle[1]
  • Participants will receive 6 injections over 74 weeks (about 1.5 years)[1]
  • The maximum dose of PD01B in a single injection is 75 micrograms[1]
  • Neither the participants nor the researchers will know who is receiving PD01B or the placebo until the study is complete[1]

Potential Benefits of PD01B

While it’s too early to know for sure, researchers hope that PD01B might:

  • Slow down the progression of Parkinson’s disease[1]
  • Improve movement symptoms[1]
  • Provide a new treatment option for people with early-stage Parkinson’s[1]

Safety Considerations

The study is closely monitoring the safety of PD01B. This includes:

  • Tracking any side effects or adverse events[1]
  • Regular physical and neurological examinations[1]
  • Brain scans to check for any changes[1]
  • Blood and urine tests[1]
  • Monitoring for any mood changes or suicidal thoughts[1]

It’s important to note that PD01B is still in the research phase. While early results are promising, more studies are needed to fully understand its effectiveness and safety for treating Parkinson’s disease[1].

Aspect Details
Study Type Phase 2, double-blind, randomized, placebo-controlled, multicenter
Drug Name PD01B (ACI-7104.056)
Target Condition Early-stage Parkinson’s Disease
Main Objectives Safety, tolerability, immunogenicity, pharmacodynamic effects
Dosage Maximum 75 μg per injection, 6 injections over 74 weeks
Key Eligibility Ages 40-75, early PD diagnosis, stable L-Dopa treatment
Primary Endpoints Adverse events, antibody response
Secondary Endpoints Alpha-synuclein biomarkers, DaT-SPECT changes, MDS-UPDRS scores
Study Duration Approximately 100 weeks, with 108-week safety follow-up

FAQ

  • What is PD01B and how does it work? PD01B is a new vaccine being tested for early-stage Parkinson's disease. It targets alpha-synuclein, a protein that plays a role in the disease. The vaccine aims to stimulate the immune system to reduce harmful forms of this protein, potentially slowing disease progression.
  • Who is eligible for this clinical trial? The trial is open to individuals aged 40-75 with early-stage Parkinson's disease, diagnosed within the last 2 years. Participants must be on a stable dose of L-Dopa and meet specific health criteria. The study excludes those with other neurological conditions or certain medical histories.
  • How is the vaccine administered? PD01B is given as an intramuscular injection. Participants receive six injections over 74 weeks: at the start of the trial, then at weeks 4, 12, 24, 48, and 74. The maximum single dose is 75 micrograms.
  • What are the main goals of this clinical trial? The primary objectives are to assess the safety and tolerability of PD01B and measure the antibody response it produces. Secondary goals include evaluating its effects on Parkinson's-related biomarkers, brain imaging results, and clinical symptoms.
  • How long does the trial last and what follow-up is involved? The trial lasts approximately 100 weeks, with a safety follow-up period extending to about 108 weeks. Participants undergo various assessments throughout the study, including blood tests, brain scans, and clinical evaluations to monitor the vaccine's effects and ensure participant safety.

Ongoing Clinical Trials on Pd01B

  • Study on the Safety and Effects of ACI-7104.056 in Patients with Early Parkinson’s Disease

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

Glossary

  • Alpha-synuclein (a-syn): A protein found in the brain that plays a role in Parkinson's disease. Abnormal accumulation of this protein is associated with the development of the condition.
  • Biomarker: A measurable indicator of a biological state or condition. In this trial, biomarkers are used to assess the effects of the vaccine on Parkinson's disease progression.
  • DaT-SPECT: Dopamine Transporter Single Photon Emission Computed Tomography, a brain imaging technique used to evaluate the function of dopamine-producing cells in Parkinson's disease.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment or placebo, helping to prevent bias in the results.
  • Idiopathic Parkinson's Disease: Parkinson's disease with no known cause, as opposed to cases caused by specific genetic mutations or environmental factors.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • L-Dopa: A medication commonly used to treat Parkinson's disease symptoms by increasing dopamine levels in the brain.
  • MDS-UPDRS: Movement Disorder Society-Unified Parkinson's Disease Rating Scale, a comprehensive system used to assess the severity of Parkinson's disease symptoms.
  • Pharmacodynamic: Relating to the biochemical and physiological effects of a drug on the body, and how these effects change over time.
  • Placebo: An inactive substance that looks like the real treatment but has no therapeutic effect, used as a control in clinical trials.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-aci-7104-056-in-patients-with-early-parkinsons-disease/