Tuesday, March 19, 2024

Parkinson’s Clinical Trials 2021

Dual Frequency Stimulation In Parkinsons Disease

A Glove To Treat Parkinsons Disease?

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Deep brain stimulation in the dorsal region of the subthalamic nucleus is very effective for reducing motor symptoms of Parkinsons disease . Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation of the ventral STN alongside standard high frequency stimulation of the dorsal STN in patients with PD.

at UC Davis

The Largest Parkinsons Disease Study Ever Attempted Is Being Made Possible Only With Mobile Research Nurses

Situation

Because Parkinson’s disease is a progressive brain disorder that leads to shaking and stiffness, eventually causing difficulty with walking, balance, and coordination, patients are at very high risk of fractures from multiple and sometimes severe falls that can lead to permanent disability and even death. Researchers are studying whether zoledronic acid, approved by the FDA to treat osteoporosis by increasing bone strength, will reduce fractures in people with Parkinsons disease.

The Trial of Parkinsons and Zoledronic acid 1 is seeking to enroll 3,500 participants over the age of 60, making it the largest double-blind, placebo-controlled, randomized clinical trial ever attempted in people with parkinsonism.

Anecdotally, only a very small proportion of people with parkinsonism receive treatment to reduce fracture risk. Barriers to seeking or receiving treatment include:

  • a lack of evidence that medical treatments will reduce fracture risk in this population
  • the conventional approach to test for bone mineral density and have follow-up medical visits to interpret, prescribe and assess response to treatment is unfamiliar to the neurologists who typically treat Parkinsons patients and
  • the notably poor compliance with oral osteoporosis treatments may be even worse for older people with parkinsonism who are already burdened by taking several other medications.

Approach

Results

References

Sample Size Statistical Analysis And Duration Of Follow Up

Even the most well-designed research question will be left unanswered if the study is underpowered. Undersized trials may end with negative results that are not interpretable, while oversized studies may find statistically significant differences that are not clinically relevant. To adequately estimate the sample size, several characteristics of the study need to be taken into account, including the experimental design, the study hypothesis, the nature of the outcome, the statistical test, the MCID, the significance threshold and power, and the expected attrition .

In AD, most trials have a parallel group design comparing intervention to placebo or two different doses of the intervention and placebo . The trials aimed to demonstrate the superiority of the intervention against placebo, typically using one of the rating scales previously discussed as continuous outcome measures. Because of the small changes expected in the outcome scales in participants at pre-clinical and prodromal stages, relatively large sample sizes have been required in AD trials, ranging from 1500 to 2000 .

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Deep Brain Stimulation For The Treatment Of Parkinsons Disease

Sorry, in progress, not accepting new patients

The purpose of this study is to evaluate the safety and effectiveness of Boston Scientifics Vercise Deep Brain Stimulation system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinsons disease which is not adequately controlled with medication.

San Francisco, California

Trends In Parkinsons Drug Development

Parkinsons Disease Drug Therapies in the Clinical Trial Pipeline: 2021 ...

In 2021, pharmaceutical companies initiated 88 Phase IIII clinical trials in Parkinsons disease, the highest number on record, according to GlobalDatas Clinical Trial Database. The number of clinical trial initiations in Parkinsons disease steadily rose between 2015 and 2018 before dips in 2019 and 2020. GlobalData, the parent company of Clinical Trials Arena, found that the proportion of Parkinsons disease trial initiations fell from 2019 because of Covid-19.

Elsewhere in Parkinsons disease, Annovis Bio CEO Maria Maccecchini also discussed the company’s Phase III trial plans and recruitment strategies with Clinical Trials Arena. Meanwhile, experts remain hopeful Roches prasinezumab can overcome a series of failures in Parkinsons disease. Finally, researchers and pharmaceutical companies are working to develop vaccines that could protect against the neurodegenerative disease.

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Deep Brain Stimulation For The Treatment Of Parkinson’s Disease

Sorry, in progress, not accepting new patients

The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific’s Vercise Deep Brain Stimulation system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson’s disease which is not adequately controlled with medication.

San Francisco, California and other locations

First Participant Treated In Phase 3 Trial Of Tavapadon For Motor Symptoms Of Parkinson Disease

  • Parkinson disease

Tavapadon has been shown in phase 2 trials to reduce improve motor symptoms of Parkinson disease as measured with the in Unified Parkinsons Disease Rating Scale Part III. Tavapadon is a D1 and D5 dopamine receptor partial agonist taken orally once daily. Currently available drugs for better motor control, in contrast, work at the D2 and D3 dopamine receptors.

The first participants have been dosed in all 3 clinical trials in a phase 3 program evaluating tavapadon. Approximately 1,200 individuals age 40 to 80 will be enrolled across all 3 trials. The primary endpoint of the TEMPO-1 and TEMPO-2 trials is the change from baseline in the MDS-UPDRS part 2 and part 3 combined score. The TEMPO-3 trial will measure change from baseline in total daily ON time without troublesome dyskinesia. A fourth 58-week, open-label, safety extension trial will also be conducted as part of the program.

We are encouraged by the benefit-risk profile of tavapadon based on the efficacy results observed in phase 2 trials, as well as the tolerability profile we have seen in our clinical program to date, said Raymond Sanchez, MD, chief medical officer of Cerevel Therapeutics. We look forward to advancing the development of tavapadon and potentially bringing a differentiated, cornerstone therapy to individuals with PD at all stages of the disease as supported by a robust phase 3 program.

Also Check: Parkinson’s Disease Non Motor Symptoms

What New Treatments Are Being Developed

Thanks to the progress we’ve already made, there are many different treatments available for Parkinson’s. And today new treatments are being tested in clinical trials that have the potential to slow, stop or even reverse Parkinson’s.

These include:

  • Stem cell therapies. These aim to use healthy, living cells to replace or repair the damage in the brains of people with Parkinson’s.
  • Gene therapies. These use the power of genetics to reprogramme cells and change their behaviour to help them stay healthy and work better for longer.
  • Growth factors . These are naturally occurring molecules that support the growth, development and survival of brain cells.

What Will A Cure For Parkinson’s Look Like

New hope for Parkinson’s disease sufferers | 9 News Australia

Parkinson’s varies so much from person to person. There are over 40 symptoms of Parkinsons. Tremor. Pain. Hallucinations. Everyones experience is different.

Because of this, there may not be a single ‘cure’.

Instead, we may need a range of different therapies to meet the needs of the individual and their specific form of the condition.

This mix may include treatments, therapies and strategies that can:

  • slow or stop the progression of the condition
  • replace or repair lost or damaged brain cells
  • control and manage particular symptoms
  • diagnose Parkinson’s at the earliest possible stage.

And this could involve medical treatments, such as drugs and surgical approaches, as well as lifestyle changes, for example to diet and exercise.

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Parkinson Progression Marker Initiative Online

open to eligible people ages 18 years and up

Parkinson Progression Marker Initiative Online is an observational study collecting participant reported information from people with and without Parkinson’s disease , for the goal of better understanding risk and predictive factors for PD. PPMI Online is part of the broader Parkinson Progression Marker Initiative aimed at identifying markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

San Francisco, California

Effects Of Osteopathic Manipulative Treatment On Gait Biomechanics In Parkinsons Disease

Sorry, in progress, not accepting new patients

Parkinsons disease is a neurological disorder that puts individuals at high risk for injuries and long-term disabilities as a result of a fall or other trauma. Injuries sustained from falls account for many deaths as well as thousands of hospital admissions and nursing home stays every month. Quality of life and even longevity itself is reduced due to the resulting surgeries, immobility, complications and even cognitive impairments that can follow. The proposed study will explore beneficial impact of a treatment modality that may significantly reduce the morbidity of this condition by comparing 6 weeks of OMT versus 6 weeks light touch intervention versus 6 weeks care as usual to improve gait in individuals with PD. Gait will be measured at mid-treatment, post-treatment and 4-week follow-up.

at UCSD

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Cerevel Therapeutics Initiates Phase 3 Program Of Tavapadon For The Treatment Of Parkinsons Disease

Studies to Enroll Approximately 1,200 Patients to Determine Effectiveness of Tavapadon Across the Full Spectrum of Early- and Late-Stage Parkinsons

BOSTON January 14, 2020 Cerevel Therapeutics, a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced the initiation of its registration-directed Phase 3 program evaluating tavapadon in patients with Parkinsons disease. The company plans to conduct three 27-week trials designed to evaluate the efficacy, safety and tolerability of fixed doses and flexible doses of tavapadon as either monotherapy in patients with early-stage Parkinsons disease or as adjunctive therapy to levodopa in patients with late-stage Parkinsons disease who are experiencing motor fluctuations. A fourth 58-week, open-label, safety extension trial will also be conducted as part of the program.

In each of the three 27-week trials, participants will be randomized to tavapadon or placebo groups. In the TEMPO-1 trial, study participants will be titrated up to a fixed dose of either 5 mg once daily or 15 mg QD of tavapadon. In the TEMPO-2 and TEMPO-3 trials, participants will be titrated upward to a dose of between 5 mg and 15 mg QD in a flexible dosing paradigm.

The TEMPO-1 and TEMPO-2 trials have already initiated screening of patients, and the TEMPO-3 trial will begin screening later this year.

Despite Life Struggles Many Patients In Survey Open To Better Future

Pharmaceuticals

A team of researchers and Parkinsons advocates including two people living with the disease reviewed clinical trials registered in online databases, to give an overview of the landscape of Parkinsons drug development. The team performed a similar analysis last year.

The aim of this report is to help people living with PD , caregivers, and researchers to navigate the growing number of clinical trials by providing an overview and analysis of the current PD drug development pipeline, the researchers wrote.

We also aim to raise awareness regarding the shape of the pipeline and the individual trials contained therein with the ultimate aim of contributing to greater participation and better trial outcomes, they added.

Researchers identified 156 relevant clinical trials on ClinicalTrials.gov and registries from the World Health Organization . About one-third were Phase 1 studies , while 46.8% were Phase 2, and 18.6% were Phase 3 .

The team provided an overview of the treatments being tested in particular, they assessed whether trials were testing symptomatic treatments that is, therapies aiming to ease Parkinsons symptoms or disease-modifying therapies , which aim to slow or stop its progression.

Of note, the proportion of Phase 1 and Phase 2 trials testing DMTs was higher in this analysis than it had been in last years, with roughly 54% of Phase 1 trials and 47% of Phase 2 trials testing investigational DMTs.

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Digital Innovations In Clinical Trials

Recently, the use of technology-based objective measures has gained substantial attention in neurological disease research. These innovative digital monitoring tools include wearable, portable, body-fixed sensors, or domestic-integrated devices that collect continuous or frequent, objective, and multidimensional data during daily activities, providing a more ecologic and reliable measure of patients’ cognition, functionality, and mobility . These digital biomarkers can potentially be useful in several stages of clinical research.

In the recruitment phase, the use of digital sensors may allow for the detection of subtle symptoms in the early stages of the disease, i.e., improving the detection of subjects at the prodromal phases of AD and PD, before symptoms can be clinically documented. In addition, in conjunction with big-data analysis and artificial intelligence tools, these objective measures may be used to predict the likelihood of an individual to convert into a clinical phenotype within a certain time frame, therefore allowing for the screening and inclusion of patients more likely to experience the outcome of interest, which could reduce trial duration and costs .

Intec Pharma’s Accordian Pill

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

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Identification Of The Study Population

The study population is the subset of the population with the condition of interest defined by the eligibility criteria. In AD and PD trials, the current trend is to recruit patients at the pre-clinical or prodromal stages of these diseases. This approach was encouraged mainly by the recognition that AD and PD pathological processes start decades before the onset of clinical symptoms and the multiple negative trials for DMT in participants with an established diagnosis. However, once individuals in the pre-clinical stages do not have clinical symptoms, the identification of the study population needs to rely on the use of biomarkers and rigorous eligibility criteria. However, biomarkers, either clinical, radiological or laboratorial are not perfect, and one cannot predict with certainty if an individual with positive biomarkers will convert into a clinical phenotype, particularly when there is no gold standard for confirmation of the diagnosis âin vivoâ .

In AD research, biomarkers have been increasingly incorporated over the past decade to confirm that cognitive decline in a given individual is actually associated with AD instead of other differential diagnoses . Also, biomarkers have gained crucial importance in identifying individuals in the pre-clinical and prodromal phases of the disease and as surrogate endpoints in the early stages of drug development trials.

Clinical Trial Highlights: Phase 3 Trials In Focus

Webinar: Volunteering for Parkinsons Research: What to Know and Expect? April 2021

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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The Journey To Approval In Parkinsons

To gain regulatory approval in Parkinsons disease, the FDA requires two late-stage trials, Dubow notes. The planned Phase II/III trial of CVN424 as an adjunctive therapy to levodopa will serve as the first registrational study, he adds.

Cerevance plans to run a second, large registrational study testing CVN424 as a monotherapy for patients who are not on levodopa, Dubow says. The biotech will first run a smaller proof-of-concept study in this population, though there is not a finalised timeline, he adds.

As for financing, Cerevance intends to raise $80100 million beginning at the end of this year or start of next year, says CEO Craig Thompson. Previously, Cerevance raised $65 million in a Series B fundraise, a July 2020 press release states.

Parkinsons Disease Drug Therapies In The Clinical Trial Pipeline: 2020

Article type: Review Article

Affiliations: Parkinsons Research Advocate, Oxford, UK | Parkinsons Research Advocate, Sunnyvale, CA, USA | Parkinsons Research Advocate, Marlboro, NJ, USA | The Cure Parkinsons Trust, London, UK

Correspondence: Correspondence to: Simon R.W. Stott, The Cure Parkinsons Trust, 120 New Cavendish Street, London. E-mail: .

Keywords: Clinical trials, studies, Parkinsons, disease modification, neuroprotection, immunotherapy, inflammation, gene therapy

DOI: 10.3233/JPD-202128

Journal: Journal of Parkinsons Disease, vol. 10, no. 3, pp. 757-774, 2020

Abstract

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The Next Generation Of Trials

Studer was part of the initial studies involving fetal tissue in the 1980s and 1990s, and knew from the start that the work was more of a proof of principle than a solution for people with Parkinsons. For me it was clear that a fetal transplant isnt a long-term solution because of ethical, legal and practical issues. Because this procedure requires 4 to 12 fetuses per patient, there was no way they could treat thousands, let alone tens of thousands, of people that way. Instead, Studer turned to stem cells.

Immunosuppression is a particularly important element of BlueRocks approach, because it relies on a single cell line that cannot be adjusted to more closely resemble the recipients own tissues. A group led by stem-cell scientist and neurosurgeon Jun Takahashi at Kyoto University in Japan is attempting to provoke a lesser immune response by pairing transplant recipients with cells that are less likely to be rejected. The researchers are using cell-surface proteins, called major histocompatibility complexes , that are recognized by the adaptive immune system and can have varying levels of compatibility from one person to another. Rather than using frozen cell lines, Takahashi and his colleagues are creating a fresh batch of MHC-matched cells for each transplant.

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