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Running Sprints Is Safe, Feasible for Those with Milder Parkinson’s, Study Finds

running sprints

Sprint running is a safe and feasible form of physical exercise for people with mild-to-moderate Parkinson’s disease.

That is the conclusion reached in the study, “Sprint exercise for subjects with mild-to-moderate Parkinson’s disease: Feasibility and biomechanical outputs,” was published in Clinical Biomechanics.

Physical exercise has been recommended for people with Parkinson’s disease because it helps to maintain balance, posture, mobility, and the ability to perform normal daily activities.

“Particularly for subjects with PD [Parkinson’s disease], a high-intensity multimodal exercise program and intensive training on a stationary bicycle were reported as feasible and safe,” the researchers wrote.

Sprint running is a type of high intensity exercise in which individuals run short distances in limited periods of time as fast as they can. In healthy individuals, sprint running increases muscle strength, physical endurance, heart and lung function and mental health.

“Although positive effects of sprint running have been reported for mouse models of PD, healthy subject and middle-aged adults, and for people with major depressive disorders, no study has investigated safety and feasibility of sprint running for individuals with PD,” the researchers wrote.

A team of Brazilian scientists decided to investigate whether sprint running could be a well-accepted, safe and feasible form of training exercise for people with mild-to-moderate Parkinson’s.

They compared the performance, satisfaction and acceptance of 20-meter (about 22-yard) sprint running training sessions among 16 men with Parkinson’s and 21 men who did not have the disease (controls). Satisfaction and acceptance were evaluated with a self-administered questionnaire, while exercise performance was determined based on biomechanic parameters — force, velocity and power — that were measured on high-speed video recordings of the sprint training sessions.

Two individuals with Parkinson’s decided to withdraw from the study. The remaining 14 patients and all individuals from the control group completed the study. Each participant, after a warm-up period, ran two sprints.

Self-administered questionnaires revealed that all participants were satisfied and felt the sprint training sessions were feasible and acceptable.

Investigators found some differences between the two groups in certain biomechanic parameters. For instance, they discovered the sprint maximal force and maximal power outputs were higher among patients with Parkinson’s, while mechanical effectiveness was higher among controls.

The maximal force and maximal power outputs refer to the maximum amount of force exerted horizontally and to the maximal mechanical power during sprint acceleration, respectively; mechanical effectiveness measures a runner’s ability to apply force against the ground more horizontally.

“Interestingly, no difference in velocity capabilities and overall 20-m[eter] sprint performance was observed between groups, possibly explained by different mechanical strategies in both groups over the sprint accelerations,” the researchers wrote.

Statistical analyses also showed that mechanical variables are important predictors of exercise performance in individuals with Parkinson’s disease.

Overall, running sprints seems to be a feasible and well-accepted exercise for those with mild-to-moderate Parkinson’s disease. Importantly, the team believes these results “are clinically relevant since sprint running could be used as a type of high-intensity exercise to rehabilitate this population with a high degree of acceptance.”

However, additional studies are required to further explore this possibility, by assessing the effects of sprint running on muscle strength, cardiorespiratory capacity, locomotion, motor symptoms, and other psychological aspects.

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#AANAM – Stem Cell Therapy Seen as Safe, May Improve Motor Function, Early Findings Suggest

mesenchymal stem cells

Treatment with mesenchymal stem cells (MSCs) — adult stem cells with regenerative effects — is safe and well-tolerated, and improves motor function in people with mild to moderate Parkinson’s disease, according to early findings from an ongoing small study.

The research, “Preliminary Report on the Safety and Tolerability of Bone marrow-derived Allogeneic Mesenchymal Stem Cells infused intravenously in Parkinson’s disease Patients,” was presented during the 2019 American Academy of Neurology (AAN) Annual Meeting, being held in Philadelphia.

MSCs — adult stem cells found in multiple tissues, such as umbilical cord, bone marrow and fat tissue — have regenerative and immunomodulatory effects, which makes them potential therapies for the chronic neuroinflammation associated with Parkinson’s.

Researchers from the University of Texas McGovern Medical School, City University of New York, and Baylor College of Medicine are assessing the safety and feasibility of allogeneic (from a donor) MSCs. The stem cells were taken from the bone marrow of a healthy adult, purified, and delivered intravenously (into the vein) in increasing doses to patients with idiopathic (of unknown cause) Parkinson’s.

The study enrolled 20 participants, including 11 men, ages 45-78. All were in off state — which refers to the resurgence of symptoms due to a gradual decline in levodopa’s efficacy — and were at stage 3 or less in the Hoehn & Yahr (H&Y) scale, correlating with mild-to-moderate disease severity. Stage three is considered mid-stage and is characterized by loss of balance and slowness of movement.

Each dose group consisted of five patients who received one of four doses of MSCs: 1, 3, 6 or 10 x106 MCS/kg of body weight. Participants are evaluated over the course of a year, at weeks 3, 12, 24 and 52.

The study’s primary outcome is safety, defined as no transfusion reactions, adverse events or organ damage. Secondary outcomes include the treatment’s impact on Parkinson’s progression, as assessed with the Unified Parkinson’s Disease Rating Scale (UPDRS), the Timed Up and Go Test of mobility and balance, the Parkinson’s Disease Questionnaire (PDQ-39) — a measure of health status and quality of life — the H&Y scale, the Columbia-Suicide Severity Rating Scale, neuroimaging, and immunologic profile.

None of the patients experienced adverse reactions within 24 hours of the single intravenous stem cell infusion. In later assessments, the most frequent side effects were hypertension, arthralgia (pain in a joint), and nausea, which were mild and temporary in all cases and did not require treatment.

To date, the first 14 treated patients showed lower (better) UPDRS-III motor scores at 12 weeks of follow-up.

“[A]llogeneic MSC infusions appear to be safe and well tolerated in subjects with mild to moderate Parkinson’s,” the researchers said.

“Our preliminary results warrant the completion of the study with the goal of identifying an ideal, well-tolerated dose that is associated with an improvement in cognition, motor function, and disability,” they added.

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ITI-214 Safe, Well-tolerated in Mild to Moderate Parkinson’s Patients, Phase 1/2 Trial Shows

ITI-214

Treatment with the experimental oral therapy ITI-214 was safe and well-tolerated in patients with mild to moderate Parkinson’s disease, according to a Phase 1/2 clinical trial.

Trial findings also suggested that ITI-214 may ease motor symptoms in these patients.

The study, “A Phase I/II Clinical Study of  ITI-214, a Novel Phosphodiesterase-I (PDE1) Inhibitor, for the Treatment of Parkinson’s Disease (PD),” was presented during AD/PD 2019 — The 14th International Conference on Alzheimer’s and Parkinson’s Diseases, taking place March 26-31 in Lisbon, Portugal.

ITI-214 is a selective blocker of an enzyme called phosphodiesterase 1 (PDE1), implicated in the breakdown of cAMP and cGMP. These two messenger molecules act within cells of the nervous system in response to diverse signals. Because altered PDE1 activity has been reported in both neurological and cardiovascular diseases, blockers such as ITI-214 are intended to restore its normal function.

Work in rodent models suggested that ITI-214, being developed by Intra-Cellular Therapies, may relieve motor and non-motor symptoms of Parkinson’s. In preclinical studies, the investigational therapy also reduced neuroinflammation through its effect on microglia — key immune cells in the central nervous system — and prevented neurodegeneration.

Data from four Phase 1 trials in healthy volunteers showed that treatment with ITI-214 was generally well-tolerated and safe.

Researchers are now presenting clinical data from the randomized, double-blind, placebo-controlled Phase 1/2 trial (NCT03387215) that primarily evaluated the safety and tolerability of increasing doses of ITI-214 in patients with mild to moderate Parkinson’s.

As secondary goals, the seven-day Intra-Cellular Therapies-sponsored study assessed the compound’s pharmacokinetics — its absorption, distribution, metabolism, and excretion in the body — as well as biomarkers of inflammation, and motor and non-motor effects through the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale.

The 40 participants (50 years and older) were maintained on stable Parkinson’s therapy. All five doses of ITI-214 — 1, 3, 10, 30, and 90 mg — were found safe and generally well-tolerated. In addition, the findings showed signals of less motor dysfunction and dyskinesia — involuntary, jerky movements — with some of the administered doses.

“Clinical data indicate that ITI-214 is safe and generally well tolerated across a range of doses in patients with mild to moderate [Parkinson’s],” the scientists wrote.

Noting that the signals of clinical improvement warrant further evaluation, the team added that “selective PDE1 inhibition may represent a novel approach for the treatment of motor and non-motor symptoms associated with [Parkinson’s].”

Of note, all seven of the study’s authors are employees of Intra-Cellular.

Besides Parkinson’s, ITI-214 is being evaluated in a Phase 1/2 trial (NCT03387215) in patients with heart failure, which is supported by results showing increased heart contraction strength in dogs and rabbits.

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