Minority Enrollment in Parkinson’s Disease Clinical Trials: Meta-Analysis and Systematic Review of Studies Evaluating Treatment of Neuropsychiatric Symptoms

2020 ◽  
Vol 10 (4) ◽  
pp. 1709-1716
Author(s):  
Daniel G. Di Luca ◽  
Jacob A. Sambursky ◽  
Jason Margolesky ◽  
Joacir Graciolli Cordeiro ◽  
Anthony Diaz ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Neuropsychiatric Symptoms ◽  
Temporal Trends ◽  
Pooled Analysis ◽  
Minority Enrollment ◽  
Pooled Prevalence ◽  
Race Ethnicity

Background: Randomized clinical trials (RCTs) in Parkinson’s disease (PD) have historically enrolled a low number of underrepresented minorities, lessening the generalizability of therapeutic developments. Although there are racial disparities in PD, little is known regarding neuropsychiatric symptoms and other nonmotor manifestations across all races/ethnicities. Objective: To assess minority participation in PD trials evaluating the treatment of neuropsychiatric symptoms and explore underlying reasons. Methods: We systematically searched PubMed and Embase for RCTs with a primary goal of treating neuropsychiatric symptoms in PD patients from 2000-2019. The pooled prevalence and 95% confidence interval (CI) of being white and enrolled in a clinical trial was calculated using the inverse variance method. I-square was calculated as a measure of heterogeneity and meta-regression was used to evaluate temporal trends. Results: We included 63 RCTs with a total of 7,973 patients. In pooled analysis, 11 (17.5%) RCTs reported race/ethnicity. Of studies reporting this data, 5 African American (0.2%), 16 Hispanics (0.64%), and 539 Asians (21.44%) were enrolled. The pooled prevalence of being white in clinical trials was 98% (CI 0.97–0.98, p < 0.001), with 1,908 patients (75.8%). NIH-funded studies were most likely to report racial data when compared to non-NIH trials (p = 0.032). Conclusion: This large pooled analysis found a small percentage of RCTs reporting race/ethnicity when evaluating treatment of neuropsychiatric symptoms in PD. There was a disproportionally high number of white patients when compared to African Americans and Hispanics. More studies are needed to investigate this discrepancy and improve rates of & minority enrollment in PD trials.

scholarly journals Drug Choices and Advancements for Managing Depression in Parkinson's Disease

2020 ◽  
Vol 18 (4) ◽  
pp. 277-287 ◽  
Author(s):  
Francesca Assogna ◽  
Clelia Pellicano ◽  
Cinzia Savini ◽  
Lucia Macchiusi ◽  
Gaia R. Pellicano ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Time Course ◽  
Rating Scales ◽  
Neuropsychiatric Symptoms ◽  
Negative Influence ◽  
Pooled Analysis ◽  
Motor Symptom ◽  
Receptor Complexes

: Depression is a frequent non-motor symptom of Parkinson’s disease (PD), and may even precede the onset of motor symptoms of parkinsonism. Beyond its negative influence on mood, depression in PD is frequently associated with other neuropsychiatric symptoms and with late-stage complications such as dementia. Despite its profound impact on the quality of life and cognitive functioning in PD, depression in PD is often under-recognized and poorly treated. : Pathophysiological studies demonstrated that depression in PD is associated with global dysfunction of interactions between discrete brain areas rather than focal structural or functional abnormalities, and that it is sustained by pathological changes of several neurotransmitter/receptor complexes. : In general, all traditional antidepressants and some dopamine agonists have been found to be safe and well-tolerated to treat depressive symptoms in PD, despite initial warning on worsening of parkinsonism. Available data suggest that the time-course of response differs among antidepressants. Efficacy results from clinical trials with antidepressant in PD are, however, rather uncertain, although pooled analysis suggests a moderate benefit. Several issues may critically impact the results of clinical trials with antidepressants in PD, including the correct psychiatric diagnosis, the overlap of symptoms between depression and PD, and the selection of appropriate end-points and rating scales.

scholarly journals Minority enrollment in Parkinson's disease clinical trials

2009 ◽  
Vol 15 (4) ◽  
pp. 258-262 ◽  
Author(s):  
Myra G. Schneider ◽  
Christopher J. Swearingen ◽  
Lisa M. Shulman ◽  
Jian Ye ◽  
Mona Baumgarten ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Minority Enrollment

scholarly journals Effectiveness of Music Therapy for the Treatment of Movement Disorders in Parkinson’s Disease

2021 ◽  
Author(s):  
Emily Calmon Londero ◽  
Ana Beatriz Cazé Cerón
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Music Therapy ◽  
Sample Size ◽  
Movement Disorders ◽  
Randomized Clinical Trials ◽  
Small Sample ◽  
Motor Deficit ◽  
Auditory Stimuli

Introduction: Body movement is synchronized by external rhythmic stimuli in conjunction with physiological control, based on an internal timing process. In this perspective, music therapy can be a potential therapeutic tool for the treatment of individuals with movement disorders as it bypasses an internal rhythm motor deficit. Objective: To evaluate the benefit of music therapy in the treatment of movement disorders in patients with Parkinson’s disease (PD). Methods: This study is a literary review, which used the PubMed platform, in April 2021, with the formula: (MOVEMENT DISORDERS) AND (MUSIC THERAPY). As search criteria, articles were selected from meta-analyzes, reviews and randomized clinical trials, published in the last 10 years, in English and studies carried out in humans. Results: 21 articles were found, 6 articles were selected according to the eligibility criteria. Most studies show an improvement in movement disorders when rhythmic musical stimuli are associated with motor interventions, such as the use of treadmills. A randomized clinical trial with 50 patients with idiopathic PD was divided into two groups, one with a treadmill and with rhythmic auditory stimuli and another with a treadmill and without auditory stimuli. Among the outcomes analyzed, the improvement in movement speed was the most beneficial aspect, with an improvement in quality of life and cognitive functions. Conclusion: It is evident that the use of music therapy in the treatment of movement disorders in patients with PD improves motor symptoms. However, the studies have a small sample size and differ in terms of the method of music therapy, the period of intervention and the scales used to assess improvement. Therefore, it is important that randomized, multicenter clinical trials with a larger sample size are carried out to prove the benefits of music therapy in a patient with Parkinson’s disease.

scholarly journals Cannabinoids in the Treatment of Parkinson’s Disease

2017 ◽  
Vol 01 (04) ◽  
pp. E307-E311 ◽  
Author(s):  
Florin Gandor ◽  
Georg Ebersbach
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Single Case ◽  
Case Reports ◽  
Therapeutic Option ◽  
Case Series ◽  
Idiopathic Parkinson’S Disease ◽  
Idiopathic Parkinson's Disease

AbstractDue to the changing legal status of medical cannabis and derivatives in numerous countries, this therapeutic option has moved into the field of public debate. Neurologists treating patients with idiopathic Parkinson’s disease are increasingly confronted with questions regarding cannabis as a treatment alternative, especially for levodopa-resistant Parkinson’s symptoms. A number of single case reports and case series suggested improvement of Parkinsonian symptoms after cannabinoid intake, but the small number of available randomized clinical trials failed to reproduce the extent of these findings. Only one trial found a reduction of levodopa-induced dyskinesia with cannabinoid treatment, the remaining three trials showed no effect on Parkinsonian symptoms. This article gives an overview on the effects of cannabis, and reviews experimental and clinical trials studying the effects of cannabinoids in idiopathic Parkinson’s disease.

scholarly journals Methodological Issues in Randomized Clinical Trials for Prodromal Alzheimer's and Parkinson's Disease

2021 ◽  
Vol 12 ◽  
Author(s):  
Camila Henriques de Aquino
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Clinical Symptoms ◽  
Clinical Stage ◽  
Protein Accumulation ◽  
Clinical Endpoints ◽  
Definition Of ◽  
Biomarker Research

Alzheimer's disease (AD) and Parkinson's disease (PD) are the first and second most common neurodegenerative disorders, respectively. Both are proteinopathies with inexorable courses and no approved disease-modifying therapies. A substantial effort has been made to identify interventions that could slow down the progression of AD and PD; to date, with no success. The advances in biomarker research improved the identification of individuals at risk for these disorders before symptom onset, recognizing the pre-clinical stage, in which there is abnormal protein accumulation but no clinical symptoms of the disease, and the prodromal stage, in which mild symptoms are present but the clinical diagnostic criteria for disease cannot be fulfilled. The ability to detect pre-clinical and prodromal stages of these diseases has encouraged clinical trials for disease-modification at earlier phases, seeking to slow or prevent phenoconversion into clinical disease. Clinical trials at these stages have several challenges, such as the identification of the eligible population, the appropriate choice of biomarkers, the definition of clinical endpoints, the duration of follow-up, and the statistical analysis. This article aims to discuss some of the methodological challenges in the design of trials for pre-clinical and prodromal phases of AD and PD, to critically review the recent studies, and to discuss methodological approaches to mitigate these challenges in trial design.

Are There Medications for Slowing Disease Progression?

2013 ◽  
Author(s):  
J. Eric Ahlskog
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Disease Progression ◽  
Randomized Clinical Trials ◽  
Lewy Bodies ◽  
Study Drug ◽  
Advisory Panel ◽  
Mao B ◽  
High Doses

If diagnosed with dementia with Lewy bodies (DLB) or Parkinson’s disease, one would naturally want to do everything possible to halt or at least slow the disease progression. Are there medications for this purpose? Unfortunately, no controlled trials have analyzed this question among people with DLB. On the other hand, multiple randomized clinical trials have assessed a variety of drugs as possible agents to slow the progression of another Lewy disorder, Parkinson’s disease. If a strategy were available to slow the progression of Parkinson’s disease, that could be relevant to all Lewy conditions. Major clinical trials assessing drugs to slow the progression of Parkinson’s disease date back to the 1980s. In each of these trials hundreds of Parkinson’s disease patients from multiple participating medical centers were enrolled and randomized to either the study drug or a placebo. Drugs that have been investigated included high doses of vitamin E; the monoamine oxidase B (MAO-B) inhibitor selegiline (deprenyl); the dopamine agonists pramipexole and ropinirole; as well as two experimental agents shown in animals to reduce apoptosis (a cell death process that might be relevant to neurodegeneration). Unfortunately, none of these large trials provided compelling evidence for slowing the progression of Parkinson’s disease. The studies’ results were either negative or so confounded and inconclusive that a meaningful interpretation could not be drawn. Most recently, the newer MAO-B inhibitor rasagiline (which also reduces apoptosis) was similarly assessed in two large clinical trials. The outcomes from these rasagiline studies were mixed and difficult to interpret. A U.S. Food and Drug Administration (FDA) Advisory Panel concluded that there was insufficient evidence to conclude that rasagiline has disease-slowing properties. What confounded these outcomes (as well as some of the earlier trials) was that the study drug also had symptomatic benefits (i.e., treated Parkinson’s disease symptoms). Since the outcome measures were clinical assessments of parkinsonism, it was difficult to distinguish symptomatic benefit from slowed disease progression. Other drugs that have been studied as potential agents to slow the progression of Parkinson’s disease include creatine (used by muscle builders) and the antibiotic minocycline.

scholarly journals Effects of Nordic walking on Parkinson’s disease: a systematic review of randomized clinical trials

2016 ◽  
Vol 23 (4) ◽  
pp. 439-447 ◽  
Author(s):  
Franciele Cascaes da Silva ◽  
Rodrigo da Rosa Iop ◽  
Beatriz Angélica Valdivia Arancibia ◽  
Elizandra Gonçalves Ferreira ◽  
Salma Stéphany Soleman Hernandez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Disease Stage ◽  
Control Group ◽  
Nordic Walking ◽  
Positive Effects ◽  
Manual Search

ABSTRACT Several exercise modalities improve the symptoms of Parkinson’s Disease (PD). Among the variety of physical exercises, Nordic walking has been used. The aim of this study was to summarize scientific literature on effects of Nordic walking on patients with PD by a systematic review of randomized clinical trials. The following electronic databases were selected: MEDLINE by Pubmed, Cochrane, PEDro, SCOPUS and Web of Science and articles identified by manual search, without restriction of date and language. The reviewers evaluated the articles and selected studies according to the eligibility criteria. The following data were extracted from the selected studies: publication identification, participants’ characteristics (sex, age, disease stage, duration of disease), experimental intervention characteristics, control group characteristics, duration, follow-up time, outcome measures and main results. Nordic walking programs with moderate and high intensities, with a minimum of 12 sessions of 60 minutes in a period from 6 to 24 weeks promoted positive effects on the severity, gait, balance, quality of life, functional capacity and motor function in patients with PD.

scholarly journals Effectiveness of gait training in water for patients with Parkinson’s Disease: systematic review

2018 ◽  
Vol 8 (4) ◽  
pp. 551-557
Author(s):  
Priscila Silva Costa ◽  
Elaine Cristina Cartaxo Villas Bôas ◽  
Erika Pedreira da Fonseca
Keyword(s):  
Systematic Review ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Methodological Quality ◽  
Randomized Clinical Trials ◽  
Gait Training ◽  
Quality Analysis ◽  
Gait Velocity

INTRODUCTION: Hydrotherapy is increasingly used in the treatment of patients with neurodegenerative disease, being aimed at improving functionality and reduce falls. Allows safe walking, promotes relaxation and reduces fear of falling. There is a requirement to analyze the methodological quality of existing studies in this context. OBJECTIVE: To systematize the knowledge about the effectiveness of water walking training for people with Parkinson's disease. METHODS: This is a systematic review. We searched the Pubmed and Lilacs database from March 2017 to May 2018 without filters. We included randomized clinical trials that verified the effects of a water gait training protocol for patients with Parkinson's disease. We excluded studies that performed water training, but not specifically gait. A Cochrane Collaboration tool was utilized to evaluate the methodological quality of the studies. RESULTS: Fifteen studies were found in the search, three of these were included. There was different from those between the articles regarding outcomes, in relation to the increase in walking speed. The methodological quality analysis showed randomization and blindness failure in the methodology of the studies. CONCLUSION: It was evidenced that gait training in water has a positive effect on gait velocity and the mobility of these individuals. For a positive clinical outcome in walking, exercises for mobility and balance should be associated. Further randomized clinical trials are necessary for follow the guidelines and have satisfactory methodological quality.

scholarly journals Does Caffeine Consumption Affect the Symptoms of Parkinson’s Disease? A Systematic Review of Clinical Trials

2021 ◽  
Vol 8 (4) ◽  
Author(s):  
Anita Reyhanifard ◽  
Sarvin Sanaie ◽  
Mojgan Mirghafurvand ◽  
Sama Rahnemayan ◽  
Arezoo Fathalizadeh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Assessment Tool ◽  
Meta Analysis ◽  
Experimental Studies ◽  
Risk Of Bias ◽  
Cochrane Library

Objectives: This systematic review of the literature was carried out to see whether coffee consumption could affect Parkinson’s disease (PD) symptoms. Methods: Randomized controlled trials (RCTs), crossover studies, and quasi-experimental studies were assessed to evaluate the effect of caffeine on PD. The databases including Medline/PubMed, ProQuest, Embase, Cochrane Library, and ClinicalTrials.gov were systematically searched. The Cochrane Collaboration’s tool for assessing the risk of bias in randomized clinical trials and the Cochrane risk of bias assessment tool for non-randomized studies of interventions (ROBINS-I) were used to assess the quality of RCTs and non-randomized clinical trials, respectively. A meta-analysis of the results was not possible because of reporting different outcomes. Results: Four papers were included in this study. Only one study reported the significant effect of caffeine on ESS and UPDRS. Another study observed no significant effect of caffeine on ESS during three- and six-week interventions. However, a significant reduction in ESS scores in the sixth week was reported after excluding four protocol violations. This study reported that the UPDRS score reduced in the third week, but significant changes were observed after six weeks. The other two studies did not show a significant effect of caffeine on ESS and UPDRS. Conclusions: Since a meta-analysis was not conducted, there was insufficient evidence to evaluate the effect of caffeine on PD. Thus, it is recommended to conduct more well-designed RCTs with a larger sample size to assess the effect of caffeine on PD.

Sign in / Sign up

Export Citation Format

Share Document