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Parkinson Disease clinical trials

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NCT ID: NCT06189170 Not yet recruiting - Safety Issues Clinical Trials

Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients

Start date: June 10, 2024
Phase: Early Phase 1
Study type: Interventional

This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.

NCT ID: NCT06175871 Not yet recruiting - Parkinson Disease Clinical Trials

New Clinical Rehabilitation Approach for the Management of Falls Risks

ReabFalls
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Accidental falls in older adults are one of the world's major pubic health problem, because of their strong association with injuries and mortality rates. In Quebec, falls are responsible for a high rate of hospitalization (more than 1800 emergency department visits every day) and deaths (more than 10,000 in recent years). Preventing falls is therefore a key mission for health professionals. This research program aims to develop a new clinical approach to the rehabilitation management of the older with a neuro-musculoskeletal disorder and a risk of falling. This program is part of a new partnership project between UQAC and specialized geriatric services at the CIUSSS Saguenay-Lac-St-Jean (La Baie site). These geriatric services admit more than 400 new patients per year, representing a large pool of participants for the new program's development. Specifically, this program has 4 phases: 1) Create a clinical profile of patients in rehabilitation care from specialized geriatric services (ex: reasons for consultation, neuro-musculoskeletal disorders, rates and causes of falls, etc.); 2) to diagnose functional deficits of these patients on different dimensions of functional and physical evaluations, using standardized tests and high-tech instruments (ex: platform of force); 3) determine the effectiveness of a new exercise intervention program (OTAGO) for falls prevention; and 4) Measure client and professional team satisfaction as well as long-term impact of this new approach used to prevent falls. The most significant impact of this new program will be to reduce public health expenditure for care of older adults with balance disorder and risk for falls; and therefore, be implanted in other CIUSSS institutions from Quebec.

NCT ID: NCT06175767 Not yet recruiting - Parkinson's Disease Clinical Trials

A Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects With Early Parkinson's Disease

Start date: July 2024
Phase: Phase 2
Study type: Interventional

A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease. Primary objective of the study is to evaluate the safety and tolerability of MT101-5 400 mg and 600 mg oral tablet total daily dose compared to Placebo in subjects with Parkinson's Disease.

NCT ID: NCT06174948 Not yet recruiting - Dystonia Clinical Trials

The Use of the CUE1 in People With Parkinson's Disease and Related Disorders

Start date: March 2024
Phase: N/A
Study type: Interventional

People with Parkinson's disease (PD) commonly experience a range of both motor (e.g., bradykinesia, rigidity, tremor, and postural instability) and non-motor (e.g., fatigue, psychiatric and behavioural disturbances, autonomic dysfunction, cognitive impairment, sleep dysfunction and olfactory loss) features. Currently, it is challenging to alleviate these symptoms with first-line treatment, the medications such as levodopa. The CUE1 is a non-invasive device, which is approved for sale in the UK market as a Class I low risk device. It is worn on the sternum or other part of the body such as the forearm and attaches to the skin via an adhesive patch which has been dermatologically tested and approved. The CUE1 delivers pulsing cueing and vibrotactile stimulation to help improve symptoms in people with PD and it has shown to be effective in doing so in previous small case studies. This 9-week feasibility study aims to investigate the feasibility, safety, tolerability and effect of using the CUE1 as an intervention to improve motor and non-motor symptoms in people with PD and related movement disorders. People with clinical diagnosis of idiopathic PD and related disorders including those with progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, and vascular Parkinsonism as well as atypical dystonias and tremor disorders aged over 18 years old who have the capacity to provide a written consent form to take part in the study, will receive as intervention to wear the CUE1 device at home, on daily basis while carrying out their activities of daily living. Participants will also have to attend four face-to-face appointments of approximately half a day, at weeks -0, -3, -6 and -9 of the study to discuss how they are getting on with using the CUE1 and complete questionnaires on their symptoms, walking, balance, and movement tests as well as a participant's clinical diary.

NCT ID: NCT06155942 Not yet recruiting - Parkinson Disease Clinical Trials

Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes

SODIPARK
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is the most common degenerative Parkinson's syndrome and is linked, among other things, to the excessive accumulation of an abnormally aggregating protein, alpha-synuclein. Progressive Supranuclear Palsy (PSP) is another Parkinson's syndrome, linked, among other things, to the abnormal accumulation of the protein Tau, and expressed clinically by falls, early cognitive impairment and oculomotor disorders, not present in PD. The onset of these disorders is so gradual that differential diagnosis between the two diseases is only possible at a late stage, on average 3 to 5 years after the onset of symptoms. To date, there is a lack of validated imaging biomarkers for diagnosing and monitoring PD and PSP. There is therefore an urgent need for the development of robust biomarkers capable of detecting neurodegeneration at an early stage, in order to aid differential diagnosis as soon as symptoms appear, and to potentially enable these patients to be included in specific therapeutic trials (as these diseases are pathophysiologically different) with potential neuroprotective effects. The development of cutting-edge technologies such as 7T MRI, combined with optimized image processing methods, now enable non-invasive in vivo exploration and analysis of these small structures in terms of ion homeostasis (sodium), microstructure (volumetry, amount of iron and neuromelanin) and connectivity.

NCT ID: NCT06145711 Not yet recruiting - Parkinson's Disease Clinical Trials

A Clinical Trial of Parkinson's Disease Treatment by hiPSCs Derived Dopaminergic Neural Precursor Cells

hiPSC-DAP
Start date: November 23, 2023
Phase: N/A
Study type: Interventional

XellSmart Biomedical (Suzhou) Co., Ltd. has closely collaborated with Shanghai East Hospital(East Hospital Affiliated To Tongji University) , using iPSC seed cells, on the development and establishment of a dopaminergic neural precursor cell production system. These iPSC seed cells are sourced from the National Stem Cell Translational Resource Bank in Shanghai East Hospital (East Hospital Affiliated To Tongji University), and the construction of the cell bank is carried out by Shanghai East Hospital. The iPSC seed cell preparation method and testing standards have been certified by National Institutes for Food and Drug Control in China. This study is conducted under collaboration between Shanghai East Hospital and XellSmart Biomedical (Suzhou) Co., Ltd. It is a distinctive stem cell therapy research targeting Parkinson's disease patients, characterized by the following: 1. The first instance in China of using autologous iPSC-derived subtype-specific dopaminergic neural precursor cells for alternative transplantation therapy in Parkinson's disease. 2. Before the initiation of this study, there was only one reported case around the world involving the use of laboratory-grade autologous iPSC-induced dopaminergic neural precursor cells for Parkinson's disease treatment in an American Caucasian individual. Positive preliminary clinical research results were obtained and published in the New England Journal of Medicine in 2020. Since then, no similar studies have been reported. It has great significance to conduct this research. It will fill two critical clinical research gaps in stem cell therapy for Parkinson's disease in the world: 1. The use of clinical-grade autologous iPSCs differentiated into dopaminergic neural cells, and treat Parkinson's disease. 2. Evaluating the safety of using autologous iPSC-differentiated dopaminergic neural cells for Parkinson's disease treatment in individuals of Asian descent or Chinese ethnicity.

NCT ID: NCT06120049 Not yet recruiting - Parkinson Disease Clinical Trials

[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DBL vs. AD

Start date: December 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Study goal: The goal of this prospective head to head comparison is to evaluate the effectiveness of [18F]-MFBG PET in assessing cardiac innervation, comparing it with [123I]-MIBG SPECT The study's primary focus is on distinguishing between Parkinson's disease (PD) and multiple system atrophy (MSA), as well as between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD). Main questions: - Feasibility: How well can [18F]-MFBG PET detect changes in myocardial uptake in PD and DLB compared to the expected normal values in healthy individuals and AD and MSA-P patients? How well can it differentiate between these groups based on the detected changes? - Non-inferiority: Is [18F]-MFBG PET as accurate as [123I]-MIBG SPECT in distinguishing between PD and MSA-P, and between DLB and AD? Participant requirements: For the main study, participants will be required to visit the hospital for 3 or 4 appointments. During these visits, they will undergo a screening visit, MRI brain scan, a comprehensive neurological assessment, [18F]-PE2I PET, [123I]-MIBG SPECT, and [18F]-MFBG PET scans. Additionally, a separate dosimetry study will be conducted, involving healthy subjects who will visit the hospital for a screening visit and undergo [18F]-MFBG PET scans.

NCT ID: NCT06094309 Not yet recruiting - Parkinson Disease Clinical Trials

Effectiveness of Botulinum Toxin in Freezing of Gate in Parkinson's Disease Walking in Parkinson's Disease.

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Freezing of gait is a symptom of Parkinson's disease (PD) that becomes more evident with the evolution of the disease, and which presents an important difference compared to the other signs and symptoms: does not respond adequately to dopaminergic therapy, which calls into question its pathophysiology. In this sense, and through empirical experience, it has been noted that freezing responds to cueing techniques (visual, sensory motor, auditory tricks, among others) which suggests a similarity with dystonic pathology. This similarity could be the basis of a common response to botulinum toxin (BT). Objectives: This study aims to understand whether BT is an effective therapy for freezing gait in patients with Parkinson's disease. Methodology: This is a prospective parallel study with therapeutic intervention, controlled by placebo, double blind. The randomization of groups will be stratified. The population will be recruited from from the CHLC movement disorders consultation, and that meets the following inclusion criteria: Parkinson's disease with freezing of gait, scoring > 1 at point 2.13 on the scale MDS-UPDRS and be responsive to cueing techniques, with severity of Parkinson's disease rated 3 or 4 on the Hoehn & Yahr scale. The BT injection will be performed by a doctor with experience in this therapy, with 100 Units (U) of type A BT, bilaterally, in the flexor muscle of the thigh, once, with replacement of the same ampoules with saline in controls. To the Patient assessments will take place over 4 months, weekly by telephone using a questionnaires on freezing and the notion of clinical improvement (FOGQ and SCGIC, respectively) and monthly in person with objective assessments using the MDS-UPDRS scales - part III motor assessment, Timed Up & Go and Two Minute Walk.

NCT ID: NCT06093399 Not yet recruiting - Clinical trials for Parkinson's Disease Stutter

Parkinsonian Sutter

Start date: December 2023
Phase: N/A
Study type: Interventional

The research team aims to provide evidence of Parkinsonian (PD) Stutter management by addressing the primary neurological issue in this disorder using Deep Brain Stimulation (DBS). The team proposes to perform unilateral DBS on 3 patients with PD stutter refractory to intensive speech therapy, to determine a response in their PD stutter. The assessments will be double-blinded. The investigators will use the outcome of this case series to determine the feasibility and details of a larger randomized controlled trial.

NCT ID: NCT06088355 Not yet recruiting - Parkinson Disease Clinical Trials

Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease

HI-LITE
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Veterans with mid to later stage Parkinson's disease (PD) may not be able to work out as hard as they need to, to prevent brain cell loss. Maybe they could work out longer and more frequently to make up for this during their good times and good weeks and then rest during the bad weeks. The investigators will compare how effective working out a lot one week per month with a break of three weeks is to continuously exercising weekly with no breaks in people with mid stage PD. The investigators will look at how fast participants walk per minute, whether they become more physically active, the biochemicals in their blood, and at how stiff their blood vessels are before and after the exercise.