Pivotal trial of adaptive deep brain stimulation device hits key milestone

Newronika's AlphaDBS system implanted in first Parkinson's study patient

Written by Patricia Inácio, PhD | Oct. 7, 2026

The first Parkinson’s disease patient has been implanted with Newronika‘s adaptive AlphaDBS, an innovative deep brain stimulation (DBS) system, as part of a pivotal clinical trial underway in Italy.

The ADVENT study (NCT06891781) will compare the adaptive AlphaDBS system with conventional DBS in people with Parkinson’s. The trial is expected to enroll 104 adults with idiopathic (unknown cause) Parkinson’s who have been referred for DBS on both sides of the subthalamic nucleus, a brain region involved in movement.

Enrollment is underway in Italy and is expected to begin soon in the U.S., with additional European centers also planned. The trial is intended to generate evidence to support a future application for U.S. approval.

“This study is designed to generate rigorous evidence by comparing adaptive and conventional stimulation in the same participants. We are grateful to the participant[s], the clinical team, and all the investigators contributing to this international study,” Lorenzo Rossi, co-founder and CEO of Newronika, said in a press release.

AlphaDBS designed to continuously sense and analyze brain signals

Parkinson’s is a progressive neurological disorder marked by motor symptoms including tremor, muscle stiffness, and bradykinesia, or slowed movement.

DBS is an established surgical treatment for some people whose symptoms are not adequately controlled with medication. It involves implanting electrodes in specific brain regions and connecting them to a pulse-generating device that delivers electrical stimulation to alter abnormal brain activity.

Conventional DBS delivers stimulation using settings programmed by a clinician, which generally remain constant until manually changed. Adaptive DBS, by contrast, monitors brain activity and automatically adjusts stimulation within clinician-set limits as a person’s needs change.

AlphaDBS is designed to continuously sense and analyze brain signals and adjust electrical stimulation in response, creating a closed-loop system.

The technology has been in clinical development for several years. In 2021, the first person with Parkinson’s was implanted with AlphaDBS in a clinical study (NCT04681534) designed to assess its safety, tolerability, and potential effectiveness. The study compared adaptive stimulation with conventional stimulation during short hospital and at-home treatment periods.

Brain chemical changes may be tied to Parkinson’s cognitive issues

Study highlights role of cerebellum in Parkinson's learning, memory problems

Written by Marisa Horak, MS | Oct. 8, 2026

  • Chemical changes in the cerebellum, particularly involving the neurotransmitter glutamate, are linked to cognitive impairment in Parkinson's disease.
  • Patients with cognitive issues showed reduced glutamate signaling markers, especially in the right side of the cerebellum.
  • Researchers emphasize the need for larger studies to validate findings and track how these brain changes progress.

Chemical changes in the brain region known as the cerebellum may play a key role in the cognitive issues experienced by people with Parkinson’s disease, a study found. The researchers used specialized MRI scans to track glutamate, a brain signaling molecule, and pinpoint the connection.

The team stressed, however, that the study was limited to a small number of patients, and emphasized the need for further tests to validate their findings. Still, they said, their findings “highlight the potential role of [the] cerebellum in [Parkinson’s]-related cognitive dysfunction.”

The study, “Cerebellar Glutamate Chemical Exchange Saturation Transfer Alterations Correlated With Cognitive Impairment in Parkinson’s Disease,” was published in NMR In Biomedicine.

Cognitive issues, such as difficulty with learning and memory, are common nonmotor symptoms of Parkinson’s. But the specific changes in the brain that lead to cognitive problems in Parkinson’s are not well defined.

Combined cognitive, biomarker testing targets Parkinson’s, related disorders

Amprion, Prema Cognition collaboration aims to identify, evaluate those at risk

Written by Andrea Lobo | Oct. 9, 2026

  • Amprion and Prema Cognition are partnering to identify and evaluate people at risk of developing Parkinson's and related disorders.
  • The approach pairs digital cognitive testing and molecular biomarker analysis.
  • The companies also plan to explore its application in clinical research and drug development.

Amprion and Prema Cognition have entered into a collaboration to explore an approach for identifying and evaluating people at risk for Parkinson’s disease and related disorders that combines digital cognitive testing with molecular biomarker analysis.

The partnership will pair Premas’ cognitive assessment technology, called Premaz, with Amprion’s biomarker testing, with Premaz helping to identify people who may need further evaluation for biomarkers of neurodegenerative diseases.

The collaboration is part of Amprion’s broader Neuro-Convergence Initiative, which aims to combine biological, cognitive, and digital measures to better understand how neurodegenerative diseases develop and progress.

“Earlier detection of neurodegenerative disease requires more than a single measurement,” Russ Lebovitz, MD, PhD, Amprion’s CEO, said in a company press release. “The Premaz digital cognitive assessment complements our molecular diagnostics by helping identify individuals who may benefit from additional testing.”

Amprion’s test detects misfolded proteins

Parkinson’s disease and related disorders, collectively known as synucleinopathies, are characterized by the buildup of clumps of misfolded proteins, particularly alpha-synuclein, in the brain. This leads to the formation of structures known as Lewy bodies. Along with Parkinson’s motor symptoms such as tremor, stiffness, and slowed movement, some patients may also develop cognitive problems.

Because symptoms can vary widely between people and overlap with those of other neurological disorders, combining information about a person’s symptoms and cognitive function with biological evidence of disease may provide a more complete picture of what is happening in the brain.

Amprion’s SAAmplify-alphaSYN, previously known as SYNTap, is a qualitative test that detects misfolded alpha-synuclein in cerebrospinal fluid, the fluid surrounding the brain and spinal cord. The test uses a seed amplification assay, a laboratory method that mimics how misfolded alpha-synuclein triggers further protein aggregation.

Detecting these abnormal aggregates can provide evidence of synuclein pathology and aid physicians in evaluating disorders such as Parkinson’s and dementia with Lewy bodies.

The test is commercially available in the U.S. and has received a breakthrough device designation from the U.S. Food and Drug Administration to aid in evaluating people for Parkinson’s.

First patient dosed in Phase 2a oral therapy trial for Parkinson’s disease

RESET will assess safety, drug exposure, and biological markers over 12 weeks

Written by Andrea Lobo | Oct. 12, 2026

  • Parkinson’s disease is characterized by the loss of dopamine-producing nerve cells, which contributes to movement difficulties and cognitive changes.
  • The RESET Phase 2a trial is evaluating Jotrol, an oral resveratrol formulation with the potential to address pathways linked to Parkinson’s, including oxidative stress and mitochondrial dysfunction.
  • Participants receive daily Jotrol or placebo to assess safety and pharmacokinetics and explore how the treatment may affect Parkinson’s symptoms.

The first patient has been dosed in a Phase 2a clinical trial evaluating Jotrol, an investigational oral formulation of resveratrol that Jupiter Neurosciences is developing for Parkinson’s disease. The trial is expected to be completed in the first half of 2029.

The RESET trial (NCT07592767) is enrolling up to 30 adults with Parkinson’s, ages 55 to 85, who are stable on standard treatments such as levodopa or dopamine agonists. The multicenter study is planned to involve about three sites in the U.S.

Oral therapy targets pathways linked to Parkinson’s

“Dosing the first patient in RESET is a significant milestone for Jupiter and the culmination of years of scientific, regulatory and clinical development work,” Christer Rosén, Jupiter’s CEO, said in a company press release. Rosén added, “With patient dosing now underway, we look forward to advancing enrollment and generating clinical data that will help us evaluate Jotrol’s potential in this significant area of unmet medical need.”

Parkinson’s disease is marked by the progressive loss of nerve cells that produce dopamine, a brain chemical that nerve cells use to communicate. The resulting loss of dopamine signaling leads to the disease’s symptoms, including movement difficulties and cognitive changes.

Several processes are thought to contribute to nerve cell damage in Parkinson’s, including brain inflammation; oxidative stress, or damage caused by harmful molecules; and problems with mitochondria, the structures that produce energy for cells.

Jotrol is a micellar formulation of resveratrol, a natural compound found in plants such as grapes, that is delivered in an oral softgel capsule. It is designed to improve resveratrol’s bioavailability — how much of the compound reaches the body and can be used — and deliver a therapeutic dose without the digestive side effects associated with other resveratrol formulations.

Jotrol can also cross the blood-brain barrier and reach the central nervous system (CNS), which includes the brain and spinal cord.

“We believe that Jotrol has the potential to address biological pathways implicated in Parkinson’s disease, including mitochondrial dysfunction, oxidative stress and neuroinflammation,” Rosén said.

Psychiatric issues often manageable during Parkinson’s infusion therapy

Study found new events in 22% of patients, often eased by dose changes

Written by Marisa Horak, MS | Oct. 13, 2026

  • Patients starting the advanced Parkinson’s disease treatment Vyalev may experience new psychiatric issues, particularly hallucinations or psychosis.
  • New-onset psychiatric symptoms were more common in patients with pre-existing cognitive impairment.
  • These psychiatric problems were generally manageable through individualized infusion-rate adjustments or low-dose antipsychotic medications.

A real-world study found that psychiatric issues, including hallucinations and delusions, developed in some people with advanced Parkinson’s disease after they started Vyalev (foscarbidopa and foslevodopa), but most were manageable with infusion-rate adjustments or low-dose antipsychotic medications.

The study, “Real-world neuropsychiatric safety profile of foslevodopa/foscarbidopa infusion in advanced Parkinson’s disease,” was published in the Journal of Neurology.

“Our findings indicate that [Vyalev] is generally well-tolerated in routine clinical practice, with most [neuropsychiatric adverse events] being mild, transient, and manageable through individualized dose adjustments and targeted pharmacological interventions,” the researchers wrote.

How Vyalev delivers Parkinson’s treatment

Parkinson’s is a neurological disorder in which brain cells that make dopamine, a chemical messenger involved in movement, become damaged and die. Levodopa is a mainstay Parkinson’s treatment that the brain converts into dopamine. It is usually given with carbidopa, which allows more levodopa to reach the brain.

Levodopa/carbidopa therapies are usually taken by mouth. Vyalev, however, is given continuously under the skin through a specialized pump. Vyalev is approved in the U.S. and many other countries to treat motor fluctuations in adults with advanced Parkinson’s disease.

Vyalev was approved based on data from clinical trials, which found that the therapy was generally well tolerated and outperformed immediate-release oral carbidopa/levodopa at controlling symptoms of Parkinson’s disease. However, clinical trials use strict eligibility criteria, so their results may not fully reflect the wider range of patients treated in routine practice.

Researchers in Italy looked back at clinical data from 77 people with advanced Parkinson’s who started Vyalev at two specialized referral centers. When they started Vyalev, their average age was 66, and they had been living with Parkinson’s for about 14 years.

Before starting Vyalev, about half of the patients met criteria for cognitive impairment. About one in four (26%) had a history of hallucinations or psychosis, and 27% had a history of impulse control disorders. Eight patients (10%) had active neuropsychiatric problems when they started Vyalev. Hallucinations involve seeing or hearing things that aren’t there, while psychosis can include delusions, or fixed beliefs without a basis in reality. These psychiatric issues are common nonmotor symptoms of advanced Parkinson’s and can be influenced by dopamine-related treatments.

All patients who remained on treatment were followed for at least six months after initiation of Vyalev. At follow-up, assessments indicated that motor symptoms had improved, consistent with benefits seen in clinical trials.