Treatment for Parkinson Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
Mercy Health Saint Mary's, Grand Rapids, MI
+2 More
Eligibility
18+
All Sexes
Eligible conditions
Parkinson Disease

Study Summary

STEM-Parkinson's Disease

See full description

Eligible Conditions

  • Parkinson Disease
  • Parkinsonian Disorders
  • Parkinson's Disease and Parkinsonism

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes, 5 secondary outcomes, and 20 other outcomes in patients with Parkinson Disease. Measurement will happen over the course of 3 months.

3 months
Change from baseline in EncephaLogTM 10 meter Timed Up and Go Test
Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test
Change from baseline in EncephaLogTM finger tapping test
Change from baseline in Epworth Sleepiness Scale
Change from baseline in Hoehn & Yahr (H&Y)
Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score
Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total score (Sum of Parts I, II and III)
Change from baseline in The Modified Schwab and England Activities of Daily Living Scale
Change from baseline in Unified Parkinson's disease Rating Scale Part I (UPDRS I)
Change from baseline in a Non-Motor Symptom focused Clinical Global Impression-Improvement
Change from baseline in the Clinical Global Impression-Improvement (CGI-I)
Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale
Change from baseline in the Geriatric Depression Scale-15
Change from baseline in the MDS-NMS Non-Motor Fluctuations
Change from baseline in the MDS-UPDRS Part III
Change from baseline in the Mini-Balance Evaluation Systems Test
Change from baseline in the Montreal Cognitive Assessment
Change from baseline in the Oral Symbol Digit Modality Test
Change from baseline in the Parkinson Anxiety Scale
Change from baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI)
Change from baseline in the Parkinson's Disease Sleep Scale
Change from baseline in the Parkinson's Disease Sleep Scale 2
Change from baseline in the Patient Reported Outcome - Parkinson's Disease
Change from baseline in the Unified Parkinson's Disease Rating Scale Part IV
Change from baseline in the Zarit Burden Interview
Change in Non-Motor Rating Scale (MDS-NMS)

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Groups

Control

This trial requires 218 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months for reporting.

Closest Location

Mercy Health Saint Mary's - Grand Rapids, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult participants (aged 18 - 85 years inclusive)
Diagnosed with Parkinson's disease according to the UK Brain Bank Criteria
Demonstrates a positive response to oral anti-Parkinsonian medications (i.e. dopamine replacement therapies) and treated with these medications for minimum of three years prior to the screening visit
Report limitation to activities of daily living (e.g., writing, walking, bathing, dressing, eating, toileting, etc.)
Able and willing to consent to participate in the study.
Willing and able to comply with study requirements.
Anticipate being able to remain on a stable regimen of medications used for the management of PD motor and non-motor symptoms and not to introduce new medications used to treat symptoms associated with PD during the trial.
Fully vaccinated from COVID-19 (at least 2 weeks from their final dose) with one of the current World Health Organization evaluated vaccines, prior to Screen.
Have at minimum a moderate burden of non-motor symptoms associated with Parkinson's disease
Have a study partner (defined as someone who sees the participant for more than one hour a day, 3 times per week) that is willing to consent and participate in the trial.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get parkinsonian disorders a year in the United States?

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parkinsonism accounts for about 15 percent of all medical visits and accounts for 50 percent of all hospital admissions. Although some causes of parkinsonism are largely unknown, most instances of parkinsonism are hypothesized to be idiopathic. An estimated 4 million Americans suffer parkinsonism and its features.

Unverified Answer

Can parkinsonian disorders be cured?

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L-DOPA is generally recommended to treat PD. In clinical studies, this treatment was shown to improve motor functions without affecting pain or tolerability. A reduction in the number of side-effects suggests a potential protective effect on the developing dopaminergic synapses. Moreover, a small proportion of patients benefited from the treatment, although these patients were found to benefit slightly or not at all on motor functions. These effects were maintained long-term and were possibly due to the long-term improvement of motor functions. In contrast, L-DOPA was less effective on cognition. Further studies seem to be worthwhile to clarify the exact effectiveness of L-DOPA and to evaluate the potential protective effects on neurons and the possible maintenance of the obtained neuroprotection.

Unverified Answer

What causes parkinsonian disorders?

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It appears that in the early stages of Parkinson's disease there are different pathologic mechanisms of substantia nigra degeneration in the left and right. Although the degeneration may be triggered by the same pathological mechanism, the clinical course is different, thus reflecting the involvement of different factors of the system.

Unverified Answer

What are the signs of parkinsonian disorders?

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Impaired balance, speech, gait initiation and abnormal finger dexterity are some of the signs of Parkinson's disease. Abnormal sleep or daytime walking, difficulty swallowing and voice abnormalities are also reported signs of parkinsonian disorders.

Unverified Answer

What is parkinsonian disorders?

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The main focus of the chapter is Parkinson's disease, a neurodegenerative disease characterized by bilateral tremors and postural instability, and also nonmotor symptoms like cognitive and behavioral disturbances. Other forms of Parkinson's disease, like early onset, familial, and early onset non-surgical are also discussed. Other parkinsonian disorders, like multiple system atrophy, are reviewed here as well. As is shown with a short history, Parkinson's disease is a complex disease with a wide span of symptoms and prognosis. Finally Parkinson's disease is the first disorder that causes Lewy bodies, which are a core protein in the parkinsonian disease brain that characterize this disease.

Unverified Answer

What are common treatments for parkinsonian disorders?

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Common treatment for PDs includes dopamine agonists, dopa decarboxylase inhibitors, anticholinergics and L-dopa. It is important to remember that while dopa decarboxylase inhibitors and dopamine agonists are usually used in the short term to manage motor symptoms, there is no cure for Parkinson's disease and long-term treatment is often needed.

Unverified Answer

What is the primary cause of parkinsonian disorders?

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The two main hypotheses can explain why the age of onset of parkinsonian disorders ranges between 30 and 80 years. The first hypothesis suggests that genetic factors have a decisive role. The second hypothesis explains the lack of correlation between the degree of severity and the age of onset of parkinsonian disorders. The third hypothesis suggests an unknown trigger that would initiate the process of neuronal degeneration.

Unverified Answer

What are the common side effects of treatment?

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The study showed that common side effects of levodopa/carbidopa and pramipexole are dizziness, headache, orthostatic hypotension, dyslipidemia, fatigue, headache, dizziness, sweating, constipation, depression, weakness, dizziness, drowsiness, urinary incontinence, cough, dyspepsia, flatulence, hypertension, constipation, dysdiarrhea, nausea and hypersalivation. Drugs taken with antipsychotic agents have also been shown to have significant side effects, such as weight gain, dry mouth, dry eyes, fatigue, blurred vision, urinary retention, dyspepsia, constipation and abdominal pain.

Unverified Answer

Is treatment typically used in combination with any other treatments?

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The majority of patients receiving treatment typically used with other treatments. Therefore, a structured approach of using multiple treatment options with other treatments is recommended in order to improve the outcomes.

Unverified Answer

Is treatment safe for people?

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The use of [Dopaminergic agonists] for the initiation of therapy was safe for patients in this study. They did not compromise neuropsychological test scores in either direction. The combination of [Dopaminergic agonists] and L-DOPA resulted in a loss of balance in both directions, which might be expected because these drugs were not used on the same day of testing. Although there are no reliable measures of the extent of dopamine-induced cognitive deficits in PD, changes in mental status, such as cognitive deficits, may be monitored in studies using dopaminergic drugs to assess the safety of such treatments.

Unverified Answer

What is the latest research for parkinsonian disorders?

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This review provides an overview of recently published research on the clinical efficacy and safety of some commonly used dopaminergic agonists and dopaminergic inhibitors in Parkinson's disease.

Unverified Answer

What is the average age someone gets parkinsonian disorders?

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Average onset age of Parkinson's disease is 68 years old. Male have a higher average age of onset and female have a lower average age of onset than male.

Unverified Answer
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