Requip Skin Patch Better Than Placebo at Improving Motor Function in Patients with Advanced Parkinson’s

Requip skin patch

When used in combination with levodopa, Requip (ropinirole) patches result in greater improvements in motor function compared to placebo for patients with advanced Parkinson’s disease, a Phase 3 clinical trial has found.

Trial findings also demonstrated the effectiveness of the new skin patch formulation was not inferior to Requip’s oral extended-release tablet formulation, suggesting the Requip skin patch may be a viable alternative option for patients.

Findings were reported in the study, “Ropinirole Patch Versus Placebo, Ropinirole Extended-Release Tablet in Advanced Parkinson’s Disease,” published in the journal Movement Disorders.

Parkinson’s disease is a neurodegenerative disorder characterized by the gradual loss of dopamine-producing neurons in the substantia nigra — a region of the brain responsible for movement control — leading up to a series of motor impairments.

Levodopa, a chemical that can be converted to dopamine in the brain,  currently is the main form of treatment used to ease the motor symptoms of Parkinson’s.

However, its long-term use can have multiple side effects, including a “wearing-off” effect (off periods), in which the medication ceases to be effective at preventing symptoms, and levodopa-induced dyskinesia (LID), a condition in which patients start having involuntary muscle movements.

Requip, marketed by GlaxoSmithKline (GSK), is a dopamine agonist — a substance that has similar properties to dopamine and can mimic some of its effects in the brain — that also has been approved to treat Parkinson’s motor symptoms.

The medication often is prescribed alongside levodopa to extend its effect and reduce the duration of off periods, and is currently available in the form of immediate and extended-release tablets.

“In addition to immediate- and extended-release tablets, a once-daily patch containing ropinirole hydrochloride was recently developed in Japan as a new transdermal formulation,” researchers wrote.

According to the researchers, the new transdermal formulation — in which the medication is slowly absorbed through the skin — being developed by Hisamitsu Pharmaceutical has the potential to improve treatment adherence, since it could provide patients who have problems swallowing and eating with a safer and easier-to-administer option.

Hisamitsu Pharmaceutical researchers conducted a Phase 3 trial (JPRN-JapicCTI-152870) to investigate if the the new skin patch formulation of Requip was as effective and safe as its original extended-release tablet formulation, and if it maintained its superiority over a placebo at reducing motor symptoms of Parkinson’s.

A total of 587 patients with advanced Parkinson’s were assigned randomly to be treated with either the Requip patch (up to 64 mg), the Requip oral extended-release tablet (up to 16 mg), or a placebo, all given once a day alongside levodopa.

The study’s main goal was to assess changes in patients’ motor function, based on the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III scores, from the beginning of the study (baseline) to week 16.

From the 587 patients randomized, 159 were excluded for not complying with the study’s randomization protocol, yielding a total of 428 participants who were included in the final analyses.

Findings revealed that patients receiving the skin patch had a mean reduction (lessening of motor symptoms) of 9.8 points in their UPDRS Part III total score, while those receiving the placebo experienced only a mean reduction of 4.3 points.

“The difference between the ropinirole patch and placebo groups was –5.4, demonstrating superiority of the patch over placebo,” the researchers wrote.

The difference in UPDRS Part III total scores between patients receiving the skin patch or the extended-release tablet was only 0.3 points, suggesting the new transdermal formulation was not inferior to Requip’s currently approved oral extended-release formulation.

Safety assessments revealed that most side effects observed in patients from all treatment groups were only mild or moderate in severity. No serious safety concerns were identified.

“The present study demonstrated the superiority of ropinirole patch over placebo with regard to the decrease of the UPDRS Part III total score, as well as non inferiority of the patch to ropinirole tablets that are currently marketed world-wide,” the researchers wrote.

The team also emphasized the new skin patch may give patients the option to “choose a favorable formulation to meet [their] own unmet medical needs, which is expected to contribute to the improved adherence.”

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Spinal Cord Stimulation Fails to Improve Mobility in Advanced Parkinson’s Patients

spinal cord stimulation trial

Despite being safe, spinal cord stimulation does not lead to significant improvements in mobility in patients with advanced Parkinson’s disease, including those taking levodopa, a prospective trial has found.

The trial findings were reported in the study, “Spinal Cord Stimulation for Very Advanced Parkinson’s Disease: A 1-Year Prospective Trial,” published in the journal Movement Disorders.

Like deep brain stimulation (DBS), spinal cord stimulation (SCS) is a form of treatment that involves implanting a small device that sends electrical signals. In the case of SCS, these electrical signals go through nerves in a patient’s spinal cord, masking pain signals before they reach the brain. This form of therapy is approved in the U.S. for treating chronic pain.

Lately there has been increasing interest in SCS as a form of treatment for Parkinson’s, based on data from studies reporting that patients who underwent SCS experienced improvements in their gait and motor function.

To explore the therapeutic potential of SCS at alleviating Parkinson’s motor symptoms, researchers at the University of Toronto in Canada conducted a prospective, open-label trial in which they assessed the safety and effectiveness of the therapy in six pain-free patients with advanced disease.

Trial participants — three men and three women, ages 31–76, who had Parkinson’s for 12–18 years — underwent surgery to have two cylindrical electrodes implanted. After surgery, all patients were followed for a period of one year.

The Unified Parkinson’s Disease Rating Scale (UPDRS) and the freezing of gait (FOG) questionnaire were used to evaluate patients’ motor function and gait impairments, respectively. Assessment evaluations were performed in all patients before, one, three, six, and 12 months after surgery.

Apart from one patient who had a temporary delirium episode after surgery, none of the study participants experienced any adverse side effects.

However, SCS had no significant effects on patient’s motor function, balance, or gait, at any time-point. Additionally, investigators found no evidence suggesting that SCS could work together with levodopa at alleviating motor symptoms of the disease.

“Despite the (…) promising outcomes reported in short, small, and open-label PD [Parkinson’s disease] studies, our study confirms safety but shows no clinically meaningful effect on patientsmobility, particularly while on L-dopa, thus failing to improve the motor signs resistant to dopaminergic treatment,” the researchers wrote.

“[W]e need further studies, enrolling larger samples and using a double-blind design, which will be possible thanks to more recent SCS modalities (e.g., burst stimulation), [to assess the therapeutic potential of SCS for Parkinson’s disease],” they added.

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Study Finds Tai Chi Improves Motor Function in Parkinson’s Patients

tai chi, Parkinson's

Tai chi improves motor function in people with mild to moderate Parkinson’s disease and may slow down disease progression, a new study has found.

The study, “Tai Chi versus routine exercise in patients with early- or mild-stage Parkinson’s disease: a retrospective cohort analysis,” was published in the Brazilian Journal of Medical and Biological Research.

Tai chi is a Chinese martial art that involves a series of fluid motions, generally accompanied by deep, meditative breathing. The slow-moving and low-impact practice offers some benefits of exercise, particularly in people who may not be able to engage in more intense physical activity.

Tai chi has been recommended as a supportive therapy for people with Parkinson’s disease. However, there hasn’t been much data to support these recommendations.

In the new study, 500 people with mild-to-moderate Parkinson’s were divided into two groups. The tai chi (TC) group received tai chi lessons, 80 minutes per day, three days per week, for two months. The routine exercise (RE) group received classes in routine exercises (including treadmill training, aerobic training, and dance) for 90 minutes per day, three days per week, for two months.

Prior to enrollment in the study, there were no significant differences between the two groups. The study population was predominantly male.

Before and after the training, the participants’ motor function was evaluated through a number of routine measurements, such as recording the time it took to walk 50 feet. Both groups showed improvement over the two months of the intervention, but across measures, improvements were significantly higher in the TC group. For example, after the intervention, the time to walk 50 feet was, on average, 8.37 seconds in the TC group and 9.71 seconds in the RE group.

Participants in the TC group also reported a significantly reduced number of falls (average of 3.45 vs. 7.45 over the past six months), and many of them discontinued or reduced the use of other therapies, such as levodopa.

When hypothesizing about why tai chi produces such positive outcomes in Parkinson’s patients, the researchers believe that it normalizes the levels of neurotransmitters that are present at lower levels in this patient population — such as dopamine and acetylcholine — in various regions of the brain.

“When tai chi is practiced daily, it promotes the development of various de novo neural pathways in a [Parkinson’s] patient that results in fast response to posture challenges,” the researchers said.

Interviews were conducted with participants after the intervention. In general, participants in both groups were positive: “Participants reported that exercises helped them improve their confidence and balance,” the researchers wrote. Notably, a greater proportion of TC participants said their intervention felt safe and helped with balance.

No adverse events were reported in the study.

“Although the study spanned over a short period of time, its results supported tai chi as an effective therapy for [Parkinson’s] patients,” the researchers wrote. They noted that further studies, evaluating such exercises over a longer period of time, will be necessary to fully understand the impact of the practice on patients.

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Cerevel Therapeutics Initiates Phase 3 Program Testing Tavapadon for Improved Motor Function

Tavapadon Phase 3 trials

Cerevel Therapeutics announced its launch of a series of Phase 3 clinical trials to evaluate its investigational therapy tavapadon, designed to improve motor function in people with Parkinson’s disease.

The company will conduct three 27-week trials to evaluate tavapadon’s efficacy, safety, and tolerability in fixed doses — TEMPO-1 (NCT04201093) — and flexible doses — TEMPO-2 (NCT04223193) and TEMPO-3 (not yet assigned an NCT number). Cerevel also will conduct a fourth 58-week, open-label, safety extension trial.

TEMPO-1 and TEMPO-2 are currently recruiting participants at a single site in south Florida. More information on enrollment can be found here and here. TEMPO-3 will begin screening prospective participants later this year.

Tavapadon is a dopamine receptor agonist, meaning that it connects with dopamine receptors on the surface of nerve cells to make them act as though dopamine were present. This is vital in treating Parkinson’s, as the disease’s defining feature is the death of dopamine-producing (dopaminergic) neurons. Dopamine is a neurotransmitter that plays a key role in coordinating movement, which is why its loss results in the motor control problems seen in Parkinson’s.

In its Phase 2 trial (NCT02847650), Tavapadon successfully eased motor symptoms in and was well-tolerated by patients with early stage Parkinson’s. The results showed that the 57 participants, ages 45 to 80, lowered their scores — indicating improvement — on the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III for motor function over the course of 15 weeks.

The upcoming Phase 3 trials will further test tavapadon’s ability to improve motor function, evaluating the therapy in more patients and over a longer period of time. Cerevel intends to enroll approximately 1,200 patients, ages 40 to 80, across all three trials.

For the TEMPO-1 and TEMPO-2 studies, Cerevel is seeking participants with early stage Parkinson’s, while people with late-stage disease, who are experiencing motor fluctuations on levodopa treatment, will be recruited for the TEMPO-3 trial. Early-stage patients will receive tavapadon alone, whereas those with late-stage Parkinson’s will be given the therapy alongside levodopa.

TEMPO-1 participants will receive a single daily oral dose of up to 5mg of tavapadon. TEMPO-2 and TEMPO-3 participants will receive between 5 mg and 15 mg on a flexible dosing schedule.

All three trials will be placebo-controlled. The primary goal of TEMPO-1 and TEMPO-2 is changes in motor function as assessed by MDS-UPDRS parts II and III. Secondary goals include safety, improvement in non-motor aspects of daily living, reduction in disease severity, lessening of daytime sleepiness, and improvements in participant-reported outcomes as measured by the Patient Global Impression of Change (PGIC) score.

The company expects to begin reporting data from the studies in the second half of 2022.

“We believe tavapadon has the potential to improve outcomes for patients with both early-stage and late-stage Parkinson’s. It is our expectation that the innovative design of each of these Phase 3 trials will allow us to demonstrate tavapadon’s ability to improve patients’ motor symptoms and functioning,” Raymond Sanchez, MD, chief medical officer of Cerevel Therapeutics, said in a press release.

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Rescuing Activity of Specific Neurons Improved Motor Function in Parkinson’s Mice


Rescuing the activity of neurons in the subthalamic nucleus — part of a brain region that controls movement — lessens motor dysfunction in a mouse model of Parkinson’s disease (PD), according to a recent study.

The “study argues that the loss of this intrinsic activity promotes abnormal synchronization and motor dysfunction in Parkinson’s disease,” Mark Bevan, PhD, the study’s senior study author, said in a press release. Bevan is a professor of physiology at Feinberg School of Medicine, Northwestern University.

The study, “Maladaptive Downregulation of Autonomous Subthalamic Nucleus Activity following the Loss of Midbrain Dopamine Neurons” was published in the journal Cell Reports.

The glutamatergic subthalamic nucleus (STN) is part of the basal ganglia, a brain region that controls movement and impulse control, and one of the key sites affected in Parkinson’s disease. Composed mainly by glutamate-producing neurons, in Parkinson’s models the firing of these neurons is decreased.

Of note, glutamate is a key excitatory neurotransmitter — chemicals that nerve cells use to send signals to other cells. Excitatory signaling from one nerve cell to the next makes the latter cell more likely to fire an electrical signal. Inhibitory signaling makes the latter cell less likely to fire.

Loss of dopamine-producing neurons, a hallmark of Parkinson’s disease, causes neurons within the STN to develop abnormal, synchronized activity, which results in impaired motor function.

Researchers at Northwestern University used a mouse model of Parkinson’s disease to investigate the mechanisms that lead to the abnormal activity of neurons within the STN.

“We first determined the mechanisms that cause STN neurons to adapt to the loss of dopamine by slowing their autonomous pacemaking activity,” said Eileen McIver, PhD, the study’s first author.

They found that loss of dopaminergic neurons resulted in lower activity “in the motor territory of the STN.” They then found that the cause for this abnormal activity was an increased activity of neurons in the basal ganglia carrying the D2 receptor. (The D2 receptor has the capacity to regulate the levels of dopamine by inhibiting the release of this neurotransmitter.)

This trigger increased the activity of an ‘indirect’ pathway” of the basal ganglia leading to additional chemical changes — activation of NMDA glutamate receptor and ATP-sensitive potassium channels — that ultimately reduced the firing of STN neurons.

Rescuing the activity of STN neurons using designer receptors exclusively activated by designer drugs (DREADDs) rapidly improved motor function in Parkinson’s mice. DREADDs are a class of engineered proteins that allow the targeted delivery of a receptor protein to specific cells.

“Within ten minutes of injecting the designer drug to activate DREADDs in the STN, we saw a symptomatic improvement,” McIver explained. Overall, these findings “provide proof-of-concept for the use of tools like DREADDs as a therapeutic approach in Parkinson’s disease,” he said.

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Coupling of Brain Electrical Signals May Be Parkinson’s Biomarker, Way to Improve Deep Brain Stimulation, Study Suggests

cross-frequency coupling electrical signals

The coupling of electrical signals in the brain — as it responds to levodopa and is associated with motor improvements — may provide ways to better assess the clinical state of people with Parkinson’s disease, and improve the efficacy of deep brain stimulation (DBS), according to new research.

The researchers say coupling patterns may enable broader insight into Parkinson’s, and have potential use as a biomarker.

The study, “Distinct subthalamic coupling in the ON state describes motor performance in Parkinson’s disease,” appeared in the journal Movement Disorders.

The human brain displays repetitive patterns of neural activity, or electrical pulses, due to the communication between brain nerve cells (neurons). These are called brainwaves.

Measuring a type of electrical pulses called local field potentials (LFPs) from the subthalamic nucleus (STN) — a brain region hyperactive in Parkinson’s patients — has shown the existence of frequency bands, or wave oscillations, that correlate with motor impairment and respond to medication.

The interactions between high- and low-frequency brain waves — cross-frequency coupling — also has been increasingly studied. This is particularly evident in unmedicated patients. Yet, what these interactions mean is still scarcely understood.

A team at the University of Houston addressed how these bands are changed by medication, as well as their coupling, via a 24-hour monitoring period that included three trials. Those trials involved nine people (seven men, ages 39-70 years) with idiopathic Parkinson’s, meaning the disease with no known cause. The participants underwent local field potential recording three weeks after deep brain stimulation of the subthalamic nucleus. The recordings were then correlated with motor improvements over three treatment cycles.

Clinical and behavioral assessments were made within 30 minutes prior to taking levodopa, which controls Parkinson’s symptoms. Similar evaluations were then done within 30 minutes after the participants said they felt the medication kicking in, in terms of motor function (verbal on state).

Specifically, the clinicians used the Unified Parkinson’s Disease Rating Scale to assess numerous symptoms: hand and foot tremors (item 20); upper and lower extremity rigidity (item 22); and finger tapping, hand open and close, hand pronation and supination — which means flipping the palm face up or face down — and leg agility (items 23–26).

A computer-based task also was used, with a keyboard. Participants had to press the left and right arrow keys sequentially and as fast as possible, for 30 seconds, using the index and middle fingers. The total number of keypresses was then analyzed.

The results showed that bradykinesia — slowness of movement — and keyboard scores differed between “off” and “on” states, meaning the periods before and after taking levodopa and regaining motor control. However, these responses did not correlate in all patients. Two patients showed eased bradykinesia yet minimal-to-no improvement in the performance of the keyboard task.

The data also showed distinct peaks across different bands. In the off state, the activity of low-beta (13-22Hz) and high-frequency oscillations (200-300Hz) was higher than normal. It was either suppressed, or shifted to a different frequency, after taking levodopa. Among other findings, six patients also showed a peak in the gamma range (50–200 Hz).

The investigators also found that, in the off state, the amplitude or signal strength of high-frequency oscillations was coupled with a specific parameter — called phase — of low-beta bands in all participants.

After the transition to the on state, this coupling shifted to a different subset of beta bands (22-30Hz) and high-frequency oscillations (300-400Hz). It also was linked with more pronounced improvements in the keyboard task scores. Only two patients failed to show this coupling after taking levodopa. That could be due to suboptimal dose, the team said.

Overall, the findings show that cross frequency coupling also exists in treated patients. “So in effect we have ‘cleared coupling’s name’ and showed the frequencies involved in coupling impacts whether its effects are negative or positive,” Musa Ozturk, the study’s lead author, said in a press release.

“Together with the differences in the ON-state coupling according to the degree of motor improvement, our observations suggest that [cross-frequency coupling] patterns provide a broader insight into [Parkinson’s], and have potential utility as a biomarker for the clinical state of patients,” the researchers said.

One potential application is deep brain stimulation.

“We can now make the closed-loop stimulator adaptive to sense a patient’s symptoms, so it can make the adjustments to the fluctuations in real time, and the patient no longer has to wait for weeks or months until the doctor can adjust the device,” said Nuri Ince, PhD, the study’s senior author.

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MS Medicine Copaxone May Have Benefits in Parkinson’s Disease, Mouse Study Finds


Treatment with Copaxone (glatiramer acetate), an FDA-approved medicine for multiple sclerosis, can restore motor function and biochemical markers in a mouse model of Parkinson’s disease, according to a recent study.

The findings, “Glatiramer Acetate Reverses Motor Dysfunction and the Decrease in 9 Tyrosine Hydroxylase Levels in a Mouse Model of Parkinson’s Disease,” were published in Neuroscience.

Parkinson’s disease, the second-most prevalent neurodegenerative disease of the elderly (after Alzheimer’s disease), is characterized by the gradual loss of muscle control, sometimes accompanied by cognitive deficits. It is mainly caused by the gradual loss of dopaminergic neurons in the substantia nigra, a region of the brain responsible for controlling body movements.

Unfortunately, so far, there are no treatments that effectively reduce or reverse degeneration of dopaminergic neurons associated with Parkinson’s disease.

“Glatiramer acetate (GA, also known as Copaxone), which is currently an FDA approved drug used in the treatment for multiple sclerosis, has been shown to directly dampen the pro-inflammatory response within the brain, in both mouse models of multiple sclerosis/experimental autoimmune encephalomyelitis and Huntington’s disease,” the researchers wrote.

Scientists set out to examine the therapeutic potential of Copaxone, an immunomodulatory drug, in the treatment of Parkinson’s disease.

In doing so, researchers used a mouse model of induced-Parkinson’s disease, in which the disorder was triggered by treating animals with MPTP, a neurotoxin that induces brain inflammation, loss of dopaminergic neurons, and motor impairments, as seen in patients with the disorder.

Treatment with Copaxone after the onset of the disease reversed gait (walking) and grip impairments in MPTP-treated mice.

Investigators believe this was due to the remarkable recovery in the levels of tyrosine hydroxylase (TH), one of the enzymes that is responsible for the production of dopamine in the striatum (a region of the brain involved in motor coordination) following treatment with Copaxone.

In addition, researchers found the number of TH-positive neurons in the substantia nigra increased slightly, albeit non-significantly, in animals treated with Copaxone, compared to those treated with a vehicle solution (control) after MPTP induction.

This was also associated with an increase in the levels of brain-derived neurotrophic factor (BDNF) — a protein whose main function is to protect dopaminergic neurons — and a decrease in the levels of IBA1, a marker of glial cells’ over-activation caused by brain inflammation. Glial cells, also known as microglia, are nerve cells that support and protect neurons.

Moreover, the levels of non-phosphorylated alpha-synuclein (syn-1), a protein directly involved in Parkinson’s disease, in the midbrain and striatum dropped significantly after MPTP induction and gradually recovered to normal levels after treatment with Copaxone. The midbrain is the region that connects the spinal cord to the brain, and plays key roles in motor movement  and auditory and visual processing.

“In this study, we show that GA [Copaxone] treatment results in restoration of motor impairments and recovery of the nigrostriatal pathway, (…) while dampening the microglia response and restoring BDNF levels,” the researchers wrote.

“Of note, this study also tested GA after the full regimen of MPTP had been completed, a time point at which there is no further loss of TH within the striatum or substantia nigra, showing that GA is a potential neurorestorative agent that has significant translational value for patients with PD [Parkinson’s disease]. To our knowledge, we are the first to test GA in a true restoration animal model of PD, resulting in recovery of the nigrostriatal pathway, leading the way for repurposing of this FDA approved drug,” they added.

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Harnessing the Power of Music

Listening to music

A proud, black piano stands in my parents’ living room. It’s the foundation of our home. From behind the sleek mahogany panels, fury, sadness, and happiness express themselves without judgment. My operatic brother sings his troubles away. My mom, a lifelong piano teacher, often alludes to the power of music because it isn’t just a creative outlet. It’s a mood-setter. It establishes rhythm and dance. Therapists use it to explore cognitive and emotional turmoil. And it also facilitates social change.

“Powerful songs have always been the engine behind the greatest social movements — it is the marching soundtrack that unites the people and gives them focus and resolve, and it’s not limited to the U.S.,” Barrett Martin writes in HuffPost. “In 1970s Nigeria, Fela Kuti invented Afro Beat music as a way to protest the oil company regime of Nigeria. His song ‘Zombie’ became a global hit that railed against Nigeria’s military dictators. In South Africa, the indigenous Mbatanga music helped bring about the end of apartheid and it spread a message of peace and reconciliation in that nation.”

If music is powerful enough to inspire entire chapters of history, what else is it capable of doing?

Parkinson’s disease and music

Music is powerful for a number of reasons; listening to it releases dopamine and serotonin – neurotransmitters that decline in Parkinson’s patients. But a study published in 2008 suggests that learning how to play an instrument also develops motor skills and reasoning abilities. Children who learned to play an instrument exhibited more advanced motor and reasoning skills than children who didn’t learn to play an instrument.

That same study states that, “Parallels between music and language have been used to support the hypothesis that music training may strengthen verbal skills.” Since music may help to develop speech patterns, exploring sound offers a tangible solution to verbal decline. Changes in speech occur with the progression of Parkinson’s. But active participation in music challenges the progression of Parkinson’s disease. Rather than observing consistent loss, Parkinson’s patients can explore music as a source of development.

Singing and Parkinson’s disease

If you’re feeling particularly enthusiastic about singing, consider joining a Parkinson’s singing group. In the same way that music changed history for entire communities, Parkinson’s singing groups offer a sense of camaraderie that’s powerful in itself. Producing endorphins in those who participate, singing is both cathartic and constructive. And it even boosts the immune system.

A small 2012 study in Norway found that group music therapy positively affected five of six Parkinson’s patients. While speech patterns didn’t noticeably improve, a decline in speech also didn’t occur during the study. This suggests that group singing may slow the progression of speech-related outcomes for Parkinson’s patients.

Singing encourages focus on breath support, diction, volume, and emotion. Vocal strength and articulation can challenge many Parkinson’s patients. But singing reinforces some of the functions that otherwise degrade.

Moving forward

Parkinson’s disease is degenerative and continuously heartbreaking in its thievery, but there are ways you can use music to fight its progression. Whether you’re interested in listening to records, picking up an instrument, or using your good ol’ vocal cords to bring happiness into your life, music offers incredible benefits to those who explore it.


Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

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Treatment with Intranasal Insulin May Improve Verbal Fluency and Motor Function, Early Study Shows

Intranasal insulin

Treatment with intranasal insulin — which is atomized into a spray and inhaled through the nose — may ease Parkinson’s disease-related cognitive impairment and motor symptoms without dangerously lowering blood sugar levels, according to a proof-of-concept trial.

The study, “Safety and preliminary efficacy of intranasal insulin for cognitive impairment in Parkinson disease and multiple system atrophy: A double-blinded placebo-controlled pilot study,” was published in PLoS ONE.

Insulin, which regulates sugar (glucose) levels in the blood, is known to have potent effects in the brain, including on cognition. Intranasal insulin treatment has been shown to increase functional connectivity in the brain in type 2 diabetes without changing serum glucose levels.

Evidence also indicates that intranasal insulin improves visuospatial (visual perception of the spatial relationships between objects) and verbal short-term memory in people with mild cognitive impairment due to Alzheimer’s disease.

Cognitive impairment is a common non-motor complication of Parkinson’s disease. However, the effects of intranasal insulin on this particular complication remain to be understood.

In this study, researchers from Harvard Medical School and University of Massachusetts designed a randomized, placebo-controlled, single-center Phase 2 trial (NCT02064166) to evaluate the effectiveness of intranasal insulin as a treatment for individuals with Parkinson’s and multiple system atrophy (MSA). The symptoms of MSA are similar to those seen in Parkinson’s, but the disorder has a quicker progression and a much shorter survival rate.

A total 14 patients, comprised of nine men and five women, were randomly assigned to receive 40 international units (IU) of intranasal insulin or saline once daily for four weeks. Nine individuals were included in the insulin group and the remaining six were allocated to the placebo group.

Participants were diagnosed and treated for Parkinson’s disease, with one subject in the insulin group also treated for possible multiple system atrophy.

During the trial, participants completed a screening visit, a baseline assessment, two follow-up visits, and an end-of-treatment assessment. Researchers performed neuropsychological testing, and evaluated patients’ motor function — using several disease severity scales and a walking test — and disease progression.

Participants kept taking their usual medications. The last intranasal insulin or placebo dose was given on the day of post-treatment assessment.

The intranasal therapy was safe and well-tolerated and there were no treatment-related side effects. Importantly, blood glucose levels remained normal in treated individuals.

Results revealed patients who received the insulin had better verbal fluency than those given the placebo. Compared with their pre-treatment assessments, individuals given insulin also had decreased disease severity and motor scores — indicating their motor symptoms were eased by treatment and that the Parkinson’s did not progress as fast.

Interestingly, the patient with probable multiple system atrophy, who was included in the insulin group, remained stable during the study and showed a tendency toward improvement of motor skills.

“Although this is a single case of INI [intranasal insulin] treatment in MSA [multiple system atrophy], it warrants further investigation as there are no therapies available to modify disease progression,” the researchers said.

No changes were observed in cognitive, depression, or gait assessments within and between groups.

“Our study provided preliminary data that suggested an improvement of functional skills after four weeks of daily INI [intranasal insulin] treatment that paves the way toward a larger cohort study to evaluate long-term safety and potential efficacy of intranasal insulin administration for potential treatment and prevention of functional decline in patients with Parkinson disease,” the study concluded.

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Study Identifies Biomarkers for Motor, Cognitive Decline in Early Parkinson’s

early Parkinson's biomarkers

Urate, a salt derived from uric acid, and homocysteine, an amino acid, may predict motor and cognitive decline in early Parkinson’s disease, researchers report.

The study with that finding, “Urate and Homocysteine: Predicting Motor and Cognitive Changes in Newly Diagnosed Parkinson’s Disease” was published in the Journal of Parkinson’s Disease.

Low levels of urate have been associated with a higher risk of developing Parkinson’s over the subsequent 15 to 20 years. Low urate plasma concentrations also have been linked to cognitive decline, including poorer performance in attention, executive, and visuospatial functions.

High levels of homocysteine — an amino acid produced by the body, usually as a byproduct of consuming meat — also has been reported to increase the risk of dementia in older adults, suggesting it may play a role in the development of Parkinson’s disease dementia (PDD).

Researchers at Newcastle University, London, England, examined the association between urate and homocysteine levels, disease progression and cognitive status over 4.5 years in early Parkinson’s disease.

A total of 154 recently diagnosed Parkinson’s patients (100 men and 54 women, mean age 66.4 years) and 99 age-matched control subjects (54 men and forty-five women, mean age 67.9 years) underwent medical assessment by a movement disorders specialist. Participants with Parkinson’s disease were evaluated in the “on” motor state (when medication is taking effect and has not worn off) and patients were able to move smoothly.

Data on disease duration, concurrent diseases, medications, smoking history, and alcohol consumption were collected.

Motor symptoms’ severity was quantified using the Movement Disorders SocietyUnified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III and the Hoehn and Yahr scale. Cognition was assessed using the Montreal Cognitive Assessment (MoCa).

Blood samples were drawn only at the study participants’ initial visit and screened for urate, homocysteine, red cell folate (to measure the body’s store of folic acid) and vitamin B12 (an essential nutrient mainly present in meat and fish). Participants were examined  four times: at the study’s initial visit (baseline) and then at 18, 36 and 54 months.

At the first visit, 73% of Parkinson’s patients were levodopa (L-DOPA) naïve, meaning they were not yet taking prescribed anti-parkinsonian medications. No significant differences were found between treated and levodopa naïve patients regarding serum urate and serum homocysteine levels.

Participants with Parkinson’s disease had significantly lower baseline urate concentrations (302.7 μmol/L) than healthy controls (331.4 μmol/L). This also was true after 18 and 36 months.

On the contrary, plasma homocysteine levels were significantly higher than those observed in healthy controls, both at baseline (11.1 vs. 9.6 μmol/L) and at 18 and 36 months.

Lower urate concentration and higher homocysteine levels were associated with worsening of motor function in early diagnosed Parkinson’s patients. However, only higher homocysteine levels at baseline correlated with worse cognitive scores over 4.5 years of follow-up.

The findings suggest both urate and homocysteine can be biomarkers that help predict motor function decline, while only homocysteine predicts cognitive changes in early Parkinson’s disease.

“These findings lend support to the hypothesis that oxidative stress may play a role in the pathophysiology of PD [Parkinson’s disease] and that motor and cognitive aspects of the disease may have overlapping but separate mechanisms,” researchers wrote.

Of note, oxidative stress is an imbalance between the production of free radicals and the ability of cells to detoxify them, resulting in cellular damage as a consequence of high levels of oxidant molecules.

“In addition to potential disease modification, our findings suggest that determining urate and homocysteine concentration at the outset may have a role in predicting patients with PD [Parkinson’s disease] at greater risk of decline in motor and cognitive function,” they concluded.

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