JPD Blog
Effect of LY3154207 on Cognition in Mild-to-Moderate Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson’s Disease (PD) or Dementia With Lewy Bodies (DLB)
Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease
Effect of Donepezil on Cognition in Parkinson’s Disease with Mild Cognitive Impairment (PD-MCI)
A Multicenter, Open-Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson’s Disease Dementia
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson’s Disease (TEMPO-1 TRIAL)
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson’s Disease (TEMPO-2 Trial)
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for PD in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3)
3 February 2021
COVID-19 Vaccination for Patients with Parkinson’s Disease Recommended
Patients with Parkinson’s disease (PD) and healthcare professionals caring for them have expressed concerns about the COVID-19 vaccine’s efficacy and safety in the specific context of PD and its symptomatic treatment. In a commentary just published in JPD, a set of experts addresses these concerns from an evidence-based perspective. Their conclusion is that COVID-19 vaccination with approved vaccines should be recommended to persons with PD, unless there is a specific contraindication.
26 January 2021
Over Half of Cannabis Users with Parkinson’s Disease Report Clinical Benefits
Amsterdam, NL – With medicinal cannabis now legalized in many parts of the world, there is growing interest in its use to alleviate symptoms of many illnesses including Parkinson’s disease (PD).
21 January 2021
Study Suggests That Gut Fungi Are Not Associated With Parkinson’s Disease
Amsterdam, NL – The bacterial gut microbiome is strongly associated with Parkinson’s disease (PD), but no studies had previously investigated the role of fungi in the gut.
25 September 2020
JPD and MJFF Accelerating the Publication of Parkinson's Disease Publication Data
Call for Submissions: To address the bias toward the publication of novel positive results, The Michael J. Fox Foundation for Parkinson’s Research and JPD invite researchers to “open their notebooks” and submit unpublished results from experiments that attempted to replicate previously published findings from other laboratories.
23 September 2020
Persons with Parkinson's Disease Can Have a Brighter Future
Amsterdam, NL – Well over six million people globally have been diagnosed with Parkinson's disease, which has an enormous impact on the lives of patients and their families and incurring mounting costs for society.
22 September 2020
Neurological Consequences of COVID-19: The “Silent Wave”
Is the world prepared a wave of neurological consequences that may be on its way as a result of COVID-19? This question is at the forefront of research underway at the Florey Institute of Neuroscience and Mental Health. A team of neuroscientists and clinicians are examining the potential link between COVID-19 and increased risk of Parkinson’s disease, and measures to get ahead of the curve.
Peer Review Process and Process for Appeals
The Journal of Parkinson's Disease operates a rigorous, timely, blinded peer-review process (with an option for double-blind if requested) by experts in the field. Manuscripts submitted to the Journal of Parkinson’s Disease will be assessed for suitability for publication in the journal by the Editors-in-Chief. Manuscripts that are deemed unsuitable may be rejected without peer review by the Editors-in-Chief and/or the Associate Editors, and the author will be informed as soon as possible. Manuscripts that are deemed suitable for peer review are forwarded to an Associate Editor with expertise in that area who then recruits appropriate anonymous referees (a minimum of two) for confidential review. Referee reports are then assessed by the Associate Editor, who makes a decision which is then subject to approval of the Editors-in-Chief. Once approved this decision is then conveyed to the author along with the referee's anonymized reports.
The initial decision will be one of the following: rejection, acceptance without revision, or potentially acceptable after minor or major revisions. Revised manuscripts will be appraised by the Associate Editor, who may seek the opinion of referees (prior or new) before making a decision, which again is subject to approval of the Editors-in-Chief. Once approved, this decision is then conveyed to the author along with the anonymized referee's reports. Once accepted manuscripts are normally published on-line without delay and appear in the next available print issue (published quarterly).
The Editors-in-Chief have ultimate responsibility for what is published in the journal. Authors may appeal decisions by contacting the Editors-in-Chief (at jpd@iospress.com). Authors will be informed in writing of the result of their appeal.
Further information for peer reviewers is available at: www.iospress.com/reviewer-guidelines.
3 August 2020
The Outlook Is Encouraging: Researchers Evaluate a Pipeline of Clinical Trials Targeting Parkinson's Disease
Amsterdam, NL – A review of currently registered clinical trials of agents targeting Parkinson's disease (PD) reveals that there is a broad pipeline of both symptomatic and potentially disease-modifying therapies currently being evaluated. Investigators report that the outlook for patients is encouraging, given the wide range of therapeutics being clinically tested. They emphasize the importance of engaging the Parkinson's community in the research. Their analysis and results are published in the >Journal of Parkinson's Disease.
22 July 2020
Journal of Parkinson's Disease Awards First Parkinson Prizes
Amsterdam, NL – The Journal of Parkinson's Diseaseand its publisher IOS Press are proud to announce the two articles that have won the first Parkinson Prize, recognizing these outstanding contributions to the advancement to Parkinson's disease research. Recipients of the award are lead investigator Thomas Foltynie, MD, PhD (research article) and co-authors Heiko Braak, MD, and Kelly Del Tredici, MD, PhD (review article).
Parkinson Prize
2022 Parkinson Prize
The Journal of Parkinson’s Disease is proud to announce the two articles that have won the 2022 Parkinson Prize. The authors of these articles are being recognized for their outstanding contributions to the advancement of Parkinson’s disease (PD) research. Recipients of the award are co-authors Thomas G. Beach, MD, PhD, FRCPC, Banner Sun Health Research Institute, and Charles H. Adler, MD, PhD, FAAN, Mayo Clinic Arizona (basic research article), and Simon Stott, PhD, Cure Parkinson’s (clinical research article).
These papers were selected by members of the Journal of Parkinson’s Disease’s Editorial Board from among 392 articles published in the 2020 and 2021 volumes. Awardees will receive a commemorative trophy and a cash award of $1,000 (per article). The Parkinson Prize will continue as an annual award presented by JPD and its publisher IOS Press.
Details about the winners of the Parkinson Prize 2022 and their research are outlined below, along with the runners-up of each prize.
“On behalf of the entire Editorial Board, we wholeheartedly congratulate the authors of the winning papers. We are honored to have the opportunity to publish these important contributions to the field in the Journal of Parkinson’s Disease,” state Editors-in-Chief Bastiaan Bloem, MD, PhD, FRCPE, and Lorraine Kalia, MD, PhD, FRCPC.
Winning basic research article: Beach, Thomas G.; Adler, Charles H.; Sue, Lucia, I; Shill, Holly A.; Driver-Dunckley, Erika; Mehta, Shyamal H.; Intorcia, Anthony J.; Glass, Michael J.; Walker, Jessica E.; Arce, Richard; Nelson, Courtney M.; Serrano, Geidy E. (2021) Vagus Nerve and Stomach Synucleinopathy in Parkinson's Disease, Incidental Lewy Body Disease, and Normal Elderly Subjects: Evidence Against the Body-First Hypothesis J Parkinsons Dis, 11, 1833-1843.
Importance of the work: The study by Beach, Adler and their colleagues builds on findings from over the past 15 years on the systemic nature of PD. There is much debate on whether PD begins with alpha-synuclein spread from the CNS to the periphery or from the periphery to the CNS. The data presented provide very strong evidence that the majority of patients with PD likely have a CNS synucleinopathy at the onset with spread in a rostro-caudal fashion to the periphery. Most other research in this field has not used autopsy confirmed cases of PD and rarely has peripheral synuclein been found without CNS alpha-synuclein. This study should help move the field forward with greater emphasis placed on PD being, in many cases, a “brain-first” disorder. The question remains whether the “body-first” hypothesis remains viable alongside the now well grounded “brain-first” hypothesis; there is certainly supportive epidemiological and animal model evidence for the “body-first” hypothesis, but human autopsies have failed to find more than isolated cases where synucleinopathy is restricted to the periphery.
“This work has only been possible through the skilled assistance of many vital individuals over the years, particularly our Pathology Technicians, headed by Mr. Anthony Intorcia, our Coordinator, Lucia Sue, and our Neuropathology Laboratory Director, Dr. Geidy Serrano,” commented Prof. Beach. Prof. Adler added, “It is an honor to receive this award and I would like to thank the many collaborators I have in the Arizona Study of Aging and Neurodegenerative Disorders as well as the support of the Michael J. Fox Foundation, Mayo Clinic, and Banner Health.”
Thomas G. Beach, MD, PhD, FRCPC, is Director of Neuroscience at Banner Sun Health Research Institute (BSHRI) in Sun City, Arizona. He was trained in neuroscience and neuropathology at the University of British Columbia (UBC) and did clinical training at UBC, New York Medical College and St. Louis University. He was appointed Assistant Professor at UBC in 1993, moving to Phoenix, Arizona in 1997, when he assumed directorship of the Civin Laboratory for Neuropathology and AZSAND. Dr. Beach has been the recipient of multiple grants and awards from agencies including the National Institutes of Health, Alzheimer’s Association, the state of Arizona and the Michael J. Fox Foundation for Parkinson’s Research. He has been an author on more than 400 publications listed by the US National Library of Medicine. Additionally, he has served industry as a consultant and as a neuropathology core leader for several imaging-to-autopsy FDA-licensing clinical trials. His research is focused on elucidating early neuropathological stages and biomarkers of normal human aging, PD, Alzheimer’s disease and other neurodegenerative diseases. His studies center on the structural and neurochemical changes of the human central and peripheral nervous system, through autopsy, biopsy and neuroimaging.
Charles H. Adler, MD, PhD, FAAN, received his PhD in pharmacology and his MD from the New York University School of Medicine. He did his neurology residency at the University of Pennsylvania and a fellowship in movement disorders at the Graduate Hospital/University of Pennsylvania in Philadelphia. He then joined the staff at Mayo Clinic in Scottsdale, Arizona.
Dr. Adler has received numerous grants to investigate the diagnosis and treatment of movement disorders, such as PD, essential tremor, dystonia, restless leg syndrome, as well as chronic traumatic encephalopathy (CTE). He currently serves as Secretary of the International Parkinson and Movement Disorder Society (MDS) and Chair of the MDS Industry Education and Services Committee and is the former Chair of the MDS Education Committee. He has previously served as the Vice-Chair of Research (Head of Human Subjects Research) at Mayo Clinic Arizona.
Dr. Adler’s main research interests are investigating tissue diagnostic tests for PD, biomarkers for early diagnosis of PD and PD with dementia, and identification of new treatments for PD and PD with dementia. Dr. Adler has also led research in two areas of sports neurology: golfers with golfer’s cramp, a task-specific dystonia, and repetitive head injuries in football players looking for clinical and neuroimaging biomarkers for CTE. He has published over 500 research papers and reviews, and edited a book entitled Parkinson's Disease and Movement Disorders: Diagnosis and Treatment Guidelines for the Practicing Physician. In 2006, Dr. Adler was awarded the Mayo Clinic Distinguished Investigator of the Year Award, and in 2022 he received the American Academy of Neurology Movement Disorders Research Award.
Winning clinical research article: McFarthing, Kevin; Buff, Susan; Rafaloff, Gary; Dominey, Thea; Wyse, Richard K.; Stott, Simon R. W. (2020) Parkinson's Disease Drug Therapies in the Clinical Trial Pipeline: 2020 J Parkinsons Dis, 10, 757-774.
Importance of the work: The clinical article by Dr. Stott and colleagues is a recurring annual report, with patient researcher Kevin McFarthing as the lead author for the Journal of Parkinson’s Disease’s special section “Clinical Trial Highlights.” This report provides the Parkinson's community (patients, clinicians and researchers alike) with an overview of the drug development pipeline for new therapies for PD. It is among the most widely downloaded and read papers published by the journal. The team of authors, which includes people living with Parkinson's and care partners, hopes that this will stimulate further engagement and interest in the clinical trial process, resulting in greater patient involvement and faster future developments.
"My co-authors and I are extremely proud to have won the Parkinson Prize,” commented Dr. Stott, “and we would like to thank the editorial team at the Journal of Parkinson’s Disease for this honor. We are very pleased that the drug development pipeline report has garnered the attention that it has. It is a very exciting time for Parkinson’s research, and we look forward to producing future versions of the report as the pipeline develops.”
Simon Stott, PhD, is a Kiwi by birth. He first developed an interest in Parkinson’s while working for an Auckland-based biotech firm called NeuronZ Ltd. At the time, Parkinson’s struck him as a very solvable problem. That interest took him to Lund (Sweden) in 2002 where he did a PhD with Profs. Deniz Kirik and Anders Bjorklund. After completing his thesis, he took up an MRC Career Development Fellowship at the National Institute for Medical Research (London). And then in 2011, he joined Prof. Roger Barker’s lab in Cambridge, where he worked on models of Parkinson’s and also volunteered to help in the weekly Parkinson’s clinics. Those clinical interactions exposed him to the patient community for the first time. The human side of the condition opened his eyes to the true complexities of Parkinson’s, but also made him aware of the lack of information being communicated about research to the patient community. In 2015, he started a blog called the “Science of Parkinson’s,” devoted to explaining interesting pieces of research news in plain English. He joined the research charity Cure Parkinson’s as their deputy director of research in 2018 and assumed the role of director of research in 2022.
Runners-Up
BASIC RESEARCH ARTICLES (in random order):
Erb, Madalynn L.; Moore, Darren J., LRRK2 and the Endolysosomal System in Parkinson's Disease (2020) J Parkinsons Dis, 10, 1271-1291.
Borsche, Max; Pereira, Sandro L.; Klein, Christine; Gruenewald, Anne, Mitochondria and Parkinson's Disease: Clinical, Molecular, and Translational Aspects (2021) J Parkinsons Dis, 11, 45-60.
Padmanabhan, Shalini; Lanz, Thomas A.; Gorman, Donal; Wolfe, Michele; Joyce, Alison; Cabrera, Carlos; Lawrence-Henderson, Rosemary; Levers, Najah; Joshi, Neal; Ma, Thong C.; Liong, Christopher; Narayan, Sushma; Alcalay, Roy N.; Hutten, Samantha J.; Baptista, Marco A. S.; Merchant, Kalpana, An Assessment of LRRK2 Serine 935 Phosphorylation in Human Peripheral Blood Mononuclear Cells in Idiopathic Parkinson's Disease and G2019S LRRK2 Cohorts, (2020) J Parkinsons Dis, 10, 623-629.
Compta, Yaroslau; Revesz, Tamas Neuropathological and Biomarker Findings in Parkinson's Disease and Alzheimer's Disease: From Protein Aggregates to Synaptic Dysfunction, (2021) J Parkinsons Dis, 11, 107-121.
CLINICAL RESEARCH ARTICLES (in random order):
Cheong, Julia L. Y.; de Pablo-Fernandez, Eduardo; Foltynie, Thomas; Noyce, Alastair J. The Association Between Type 2 Diabetes Mellitus and Parkinson's Disease (2020) J Parkinsons Dis, 10, 775-789.
Fearon, Conor; Fasano, Alfonso Parkinson's Disease and the COVID-19 Pandemic (2021) J Parkinsons Dis, 11, 431-444.
Jost, Stefanie T.; Chaudhuri, K. Ray; Ashkan, Keyoumars; Loehrer, Philipp A.; Silverdale, Monty; Rizos, Alexandra; Evans, Julian; Petry-Schmelzer, Jan Niklas; Barbe, Michael T.; Sauerbier, Anna; Fink, Gereon R.; Visser-Vandewalle, Veerle; Antonini, Angelo; Martinez-Martin, Pablo; Timmermann, Lars; Dafsari, Haidar S. Subthalamic Stimulation Improves Quality of Sleep in Parkinson Disease: A 36-Month Controlled Study (2021) J Parkinsons Dis, 11, 323-335.
Knudsen, Karoline; Fedorova, Tatyana D.; Horsager, Jacob; Andersen, Katrine B.; Skjaerbaek, Casper; Berg, Daniela; Schaeffer, Eva; Brooks, David J.; Pavese, Nicola; Van den Berge, Nathalie; Borghammer, Per Asymmetric Dopaminergic Dysfunction in Brain-First versus Body-First Parkinson's Disease Subtypes (2021) J Parkinsons Dis, 11, 1677-1687.
JPD is proud to publish such high quality work and acknowledges the excellent contributions by these authors and all those who were in the running.
9 July 2020
Hospital Improves On-Time Administration of Medication to Parkinson Patients
Amsterdam, NL – Timely administration of anti-Parkinson drugs is a significant issue for hospitalized patients with Parkinson's disease (PD) with late or missed doses resulting in longer stays and worse outcomes.
7 July 2020
Journal of Parkinson's Disease Achieves Significant Impact Factor Increase
Amsterdam, NL – The Journal of Parkinson's Disease (JPD) and its publisher IOS Press are proud to announce that JPD's Journal Impact Factor has increased to 5.178 according to Clarivate's 2020 edition of the Web of Science Journal Citation Reports™ (JCR). This represents an impressive 40% increase from last year.
4 June 2020
Growth Factors and Parkinson's Disease – Where Next?
Growth factors such as glial cell line-derived neurotrophic factor (GDNF) were initially thought to be exciting new treatments for Parkinson’s disease, but trials have been disappointing. A panel of prominent leaders in the field convened to discuss whether there is a future for this approach and what any future PD trial involving GDNF and other GDNF family neurotrophic factors should consider. Their discussions and recommendations are published in the Journal of Parkinson's Disease.
12 May 2020
COVID-19 May Compound the Social and Economic Burdens of Parkinson's Disease
Amsterdam, NL – Parkinson's disease (PD) is expected to reach over 14 million cases worldwide by 2040. As longevity increases, so does the number of persons living with PD.
Multicenter, Randomized, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson’s Disease
GLP1R in Parkinson’s Disease (GIPD)
A Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson’s Disease
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-Stage Parkinson’s Disease
Effects of Exenatide on Motor Function and the Brain
SR-Exenatide (PT320) to Evaluate Efficacy and Safety in Patients With Early Parkinson’s Disease
Effect of Exenatide on disease progression in early Parkinson’s Disease.
Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson’s Disease (Exenatide-PD3)
6 May 2020
New Trial Platform Could Accelerate Finding a Cure for Parkinson's Disease
Despite 30 years of research, not a single therapy has been found to successfully delay or stop the progression of Parkinson's disease. In the Journal of Parkinson's Disease scientists report on the possibility of using a multi-arm, multi-stage trial platform to evaluate several potential therapies at once, using lessons learned from other diseases.
5 May 2020
New Evidence that Higher Caffeine and Urate Levels Are Protective Against Parkinson’s Disease
Two purines, caffeine and urate, have been associated with a reduced risk of Parkinson's disease (PD) in multiple study groups and populations. Analysis of data from the Harvard Biomarkers Study shows that lower levels of caffeine consumption and lower blood urate are inversely associated with PD, strengthening the links between caffeine intake and urate levels and PD, reports a study in JPD.
3 April 2020
Patients with Parkinson's Disease Face Unique "Hidden Sorrows" Related to the COVID-19 Pandemic
Amsterdam, NL – While much attention has focused on the potential for severe respiratory complications and unfavorable outcomes from the COVID-19 pandemic among patients with Parkinson's disease (PD), the impact extends beyond these threats.
12 February 2020
Simple Blood Test Could Help Predict Progression of Parkinson's Disease
Amsterdam, NL – In order to provide the best medical care for newly diagnosed Parkinson's disease (PD) patients, a method of predicting their cognitive and motor progression, beyond using purely clinical parameters, would have major implications for their management.
11 February 2020
Long-Distance Skiers May Have "Motor Reserve" that Can Delay Onset of Parkinson's Disease
Amsterdam, NL – To better understand the relationship between physical activity and Parkinson's disease (PD) investigators in Sweden analyzed medical records of nearly 200,000 long-distance skiers who took part in the Vasaloppet cross-country ski race.
A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson’s Disease
A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson’s Disease Experiencing Motor Fluctuations (BouNDless).
Apomorphine Pump in Early Stage of Parkinson’s Disease (EARLY-PUMP)
Infusion of Apomorphine: Long-term Safety Study (INFUS-ON)
Levodopa Pharmacokinetics in Patients With Parkinson’s Disease and Symptom Fluctuation: A Phase I, Open-label, Randomized, Multicentre, Crossover Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa
A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson’s Disease Patients With Motor Fluctuations
14 January 2020
Journal of Parkinson's Disease Welcomes New Co-Editor-in-Chief Bastiaan R. Bloem
Amsterdam, NL – The Journal of Parkinson's Disease (JPD) is pleased to announce the appointment of Prof. Bastiaan (Bas) R.
Clinical Trial Highlights: Resource List
The Clinical Trials Highlights section in JPD is a resource centre for academics, medics, industry and persons with Parkinson's (PwP), particularly those wanting to participate in clinical trials. As a reference tool, a list of clinical trials resources relating to Parkinson's disease is included in this section.
Clinical Trials Resources
Click on the link to be taken to the external resource
PARKINSON'S THERAPIES IN DEVELOPMENT
FINDING A CLINICAL TRIAL
ClinicalTrials.gov from the US National Library of Medicine
PD Trial Tracker; analysing ClinicalTrials.gov for Parkinson’s specific trials
Michael J. Fox Foundation, Fox Trial Finder
Michael J. Fox Foundation, Study Recruitment
European Parkinson’s Disease Association
Parkinson’s UK
UK NHS Clinical Trials Gateway
Cure Parkinson’s Trust
Parkinson’s Study Group
American Parkinson Disease Association
CenterWatch
WHAT DOES IT MEAN TO PARTICIPATE IN A CLINICAL TRIAL?
Michael J Fox Foundation, Navigating Clinical Trials
Parkinson’s Foundation, Clinical Trials
If you are a researcher or scientist who knows of a resource link that would be of interest to add to this list, we would love to hear from you. Please contact us and let us know by email: jpd@iospress.com
Clinical Trial Highlights: Phase 3 Trials in Focus
Phase 3 studies need particular attention as they are the closest to market, so each edition of Clinical Trial Highlights will have a 'Phase 3 in Focus', selecting one study for analysis. These are listed on the overview of articles on the main Clinical Trial Highlights page here, and below is a list of short extracts from each article. Click the "Read More" link to access the full analysis in the JPD article on the IOS Press Content Library.
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Update on Previously Reviewed Trials
(Publication Date: February 2022)
Background: The Journal of Parkinson’s Disease started the Clinical Trial Highlights (CTH) section in January 2019. The objective is “to raise awareness of the clinical trial landscape in Parkinson’s disease (PD), promoting discussion and progress in the conduct and outcome of studies.” In addition, it is intended to be “a resource center for academics, medics, industry, and people with Parkinson's disease (PwP), particularly those wanting to participate in clinical trials.” After three years, it is useful to step back and review the progress of the trials we featured. Since the start, we have reviewed studies in seven categories. The CTH section has hosted two reviews of the clinical trials pipeline in August 2021 and August 2020. Since the start of the CTH section, we have covered twelve phase 3 studies in focus, ten symptomatic and two potentially disease modifying therapies. Six of the covered studies have been completed, and six continue with recruitment. READ MORE (see p.534 in the PDF)
Ampreloxetine, Theravance Biopharma
(Publication Date: April 2021)
Background: Ampreloxetine has been through a successful phase 2 study (NCT02705755) demonstrating proof of concept. There are three phase 3 trials in progress. The first, SEQUOIA, is a four-week randomized, placebo-controlled, double-blind parallel group design. Participants who, in the opinion of the investigator, will benefit from continued treatment with ampreloxetine, will then move on to the REDWOOD study, which lasts for 22 weeks and includes a six-week randomized withdrawal. Those patients that complete REDWOOD can then move onto an open label safety and tolerability study named OAK, lasting for three years. These phase 3 studies are reviewed below. In parallel, Theravance Biopharma are also conducting a phase 1 pharmacokinetic study in people with hepatic impairment. READ MORE
Tavapadon
(Publication Date: February 2021)
Background: Tavapadon is a novel D1 selective dopamine agonist being developed by Cerevel Therapeutics. D1 receptors have been of particular interest owing to modulation of the direct pathways. Prior attempts at developing D1 selective agonists were met with tolerability issues and poor pharmacokinetics. Non-catechol-based agents were designed mainly to overcome the challenges noted with previous D1 agonist medications. Tavapadon is one such medication belonging to the novel class of non-catechol-based agents. It is a potent, orally bioavailable, partial dopamine agonist selectively targeting D1/D5 receptors. READ MORE (see p.26 in the PDF)
Amneal's IPX203
(Publication Date: January 2020)
Background: There is a clear clinical need for oral formulations of levodopa that deliver optimal levels in the bloodstream for extended periods of time. Whilst such formulations exist and are used, for example, Sinemet CR and Rytary, there is still considerable room for improvement. Impax Laboratories, acquired by Amneal in 2018, sells Rytary, but are also developing IPX203, aimed to have a longer half-life than Rytary. Both drugs are manufactured as capsules containing different particle forms of levodopa and carbidopa (LD/CD). The mix of particles enables the combination of immediate release (IR) of LD/CD together with sustained release LD/CD over an extended period of time. READ MORE (see p.15 in the PDF)
Adamas Pharma's Gocovri
(Publication Date: July 2019)
Background: The Phase 3 in focus for this edition of Clinical Trial Highlights continues the theme of symptomatic relief of dyskinesia in PD. We will review two Phase 3 trials already completed on amantadine ER (Gocovri), previously known as ADS-5102 during development, EASE LID and EASE LID 3. Gocovri is a capsule containing 137mg extended-release amantadine, an uncompetitive antagonist at the N-methyl-D-aspartate receptor known to have benefit to relieve the symptoms of dyskinesia and currently the only available molecule for management of dyskinesia. The rationale of extended release is to provide a therapeutic level of amantadine in the blood for a longer period of time, in this case enabling once a day dosing. Two capsules are administered at bedtime to give a slow increase during sleep, peak levels in the morning and a sustained concentration during the day. READ MORE (see p.451 in the PDF)
Intec Pharma's Accordian Pill
(Publication Date: May 2019)
Background: Levodopa remains the most potent symptomatic therapy for PD. One of the major limitations of levodopa therapy is the risk of development of motor fluctuations and dyskinesia related to the short half life of the drug, coupled with progressive decline of neuronal dopamine storage capacity. Current formulations of levodopa are generally taken every few hours, leading to a pulsatile profile of peaks and troughs. The peaks can induce troublesome dyskinesia while the troughs can lead to OFF time with significant symptom breakthrough. A steadier and more consistent plasma profile should reduce the incidence of both types of motor fluctuation as well as reducing the number of tablets patients need to take. Intec Pharma have developed the Accordion Pill, a gastric-retentive capsule containing multiple layers of both immediate release and controlled release levodopa and carbidopa. The pill remains in the stomach for up to 12 hours. READ MORE (see p.262 in the PDF)
Isradipine
(Publication Date: February 2019)
Background: Isradipine, a dihydropyridine calcium channel antagonist (DHP) that is approved for the treatment of hypertension, is being tested as a potential disease modifying intervention in early PD. Isradipine was shown to be neuroprotective in in vitro and in vivo models of parkinsonism. The mechanism of neuroprotection is linked to selective vulnerability of substantia nigra pars compacta neurons that preferentially express L-type calcium channels. Neuroprotective effects of isradipine are achieved at a plasma concentration that is obtained within the safe dose range for human administration and consistent with the tolerable dosage identified in the phase II study of isradipine in PD (STEADY-PDII). A number of epidemiological studies have demonstrated a reduced risk of development of PD in individuals treated with DHPs compared to other antihypertensive agents. READ MORE
Clinical Trials Highlights: Editors
Dear Readers,
The Clinical Trials Highlights of JPD was launched at the start of 2019 and is devoted to raising awareness of the clinical trial landscape in Parkinson’s, promoting discussion and progress in the conduct and outcome of studies. Please help us to make a difference to the outcome of clinical trials in Parkinson’s, looking forward to a time when clinical progress matches the performance in the lab. If you feel that you would like to draw attention to a specific trial, please get in touch!
Sincerely,
Kevin McFarthing
JPD Co-Editor of Clinical Trials Highlights
Parkinson’s Advocate, Innovation Fixer Ltd, Oxford, UK
Tanya Simuni
JPD Co-Editor of Clinical Trials Highlights
Parkinson's Disease and Movement Disorders Center
Northwestern University Feinberg School of Medicine, Chicago, USA
Contact
Email: jpd@iospress.com
Clinical Trial Highlights
The Clinical Trial Highlights section of JPD was launched at the start of 2019 and is devoted to raising awareness of the clinical trial landscape in Parkinson’s, promoting discussion and progress in the conduct and outcome of studies. All content in this section is freely available to read, download and share.
You can find in this section of the website (below) an overview of articles published in regular issues of JPD. For details of individual trials, go here or click the visual above. For short extracts of the "Phase 3 Trials in Focus" articles, go here. For a list of Clinical Trials Resources, go here.
To search for specific topics, input free text into the search box at the top right of the website. To fine tune the results, put words in quote marks (e.g. "trial" "dyskinesia").
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Clinical Trial Highlights: Articles
Content included in regular (not all) issues of JPD: listed below with the most recent issue at the top; click the link to be taken to the relevant article published in JPD
JPD Volume 14, Issue 5 (2024)
Parkinson’s Disease Drug Therapies in the Clinical Trial Pipeline: 2024 Update
Research article by Kevin McFarthing, Sue Buff, Gary Rafaloff, Kenneth Pitzer, Brian Fiske, Anaya Navangul, Katelyn Beissert, Aleksandra Pilcicka, Rosie Fuest, Richard K. Wyse and Simon R.W. Stott
JPD Volume 14, Issue 1 (2024)
Clinical Trial Highlights: Dietary Interventions in Parkinson’s Disease
Research article by Indy van der Berg, Sabine Schootemeijer, Karin Overbeek, Bastiaan R. Bloem and Nienke M. de Vries
JPD Volume 13, Issue 6 (2023)
Clinical Trial Highlights: Modulators of Mitochondrial Function
Research article by Francesco Capriglia, Toby Burgess, Oliver Bandmann and Heather Mortiboys
JPD Volume 13, Issue 4 (2023)
Parkinson’s Disease Drug Therapies in the Clinical Trial Pipeline: 2023 Update
Research article by Kevin McFarthing, Susan Buff, Gary Rafaloff, Brian Fiske, Leah Mursaleen, Rosie Fuest, Richard K. Wyse and Simon R.W. Stott
JPD Volume 13, Issue 3 (2023)
Clinical Trial Highlights: Interventions Promoting Physical Activity in Parkinson’s Disease
Research article by Thomas H. Oosterhof, Sabine Schootemeijer and Nienke M. de Vries
JPD Volume 12, Issue 8 (2022)
Clinical Trial Highlights – Aerobic Exercise for Parkinson’s Disease
Research article by Sabine Schootemeijer, Sirwan K.L. Darweesh and Nienke M. de Vries
JPD Volume 12, Issue 4 (2022)
Parkinson’s Disease Drug Therapies in the Clinical Trial Pipeline: 2022 Update
Review article by Kevin McFarthing, Gary Rafaloff, Marco Baptista, Leah Mursaleen, Rosie Fuest, Richard K. Wyse, and Simon R.W. Stott
JPD Volume 12, Issue 2 (2022)
Clinical Trial Highlights – An Update on Previously Reviewed Trials
Clinical Trial Highlights: Phase 3 in Focus – Update (see p.534 in the issue, see PDF)
JPD Volume 11, Issue 3 (2021)
Parkinson’s Disease Drug Therapies in the Clinical Trial Pipeline: 2021 Update
Review article by Kevin McFarthing, Gary Rafaloff, Marco A.S. Baptista, Richard K. Wyse, and Simon R.W. Stott
JPD Volume 11, Issue 2 (2021)
Clinical Trial Highlights – Kinase Inhibitors
Clinical Trial Highlights: Phase 3 in Focus – Ampreloxetine, Theravance Biopharma
JPD Volume 11, Issue 1 (2021)
Clinical Trial Highlights – Parkinson’s Disease Cognition
Clinical Trial Highlights: Phase 3 in Focus – Tavapadon (see p.26 in the issue, see PDF)
JPD Volume 10, Issue 3 (2020)
Parkinson’s Disease Drug Therapies in the Clinical Trial Pipeline: 2020
Research article by Kevin McFarthing, Susan Buff, Gary Rafaloff, Thea Dominey, Richard K. Wyse, and Simon R.W. Stott; view press release here
JPD Volume 10, Issue 2 (2020)
Clinical Trial Highlights: GLP-1 agonists
JPD Volume 10, Issue 1 (2020)
Clinical Trial Highlights: Infusion Therapies
Clinical Trial Highlights: Phase 3 in Focus – Amneal's IPX203 (see p.15 in the PDF)
JPD Volume 9, Issue 3 (2019)
Clinical Trial Highlights: Dyskinesia
Clinical Trial Highlights: Phase 3 in Focus – Adamas Pharma's Gocovri (see p.451 in the PDF)
JPD Volume 9, Issue 2 (2019)
Clinical Trial Highlights: Gene Therapy for Parkinson's
Clinical Trial Highlights: Phase 3 in Focus – Intec Pharma's Accordian Pill (see p.262 in the PDF)
JPD Volume 9, Issue 1 (2019)
Editorial: Introducing Clinical Trials Highlights
Clinical Trials Highlights: Targeting Alpha-Synuclein
Clinical Trials Highlights: Phase 3 in Focus – Israpidene
15 November 2019
Fecal Transplantation to Treat Patients with Parkinson’s Disease: Hope or Hype?
In this review, investigators evaluate the current state of knowledge about the potential for using fecal microbiome transplantation to restore the normal microbial balance of the gut in PD patients. It is published in the open access JPD special issue on "The Gut-Brain Axis in Parkinson's Disease".