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Replies to post #194403 on Anavex Life Sciences Corp (AVXL)
Melbourne trial of new drug to treat Parkinson's dementia
1 May 2019
A clinical trial evaluating experimental drug Anavex 2-73 as a treatment for Parkinson’s disease dementia is now for the first-time recruiting volunteers through HammondCare’s Clinical Trials Unit in Melbourne.
This is one of only two sites in Australia participating in the phase 2 study, with the other being KaRa MINDS in Sydney.
Principal investigator for the Melbourne trial is HammondCare’s A/Prof Stephen Macfarlane who is also involved in ongoing trials for the same drug as a treatment for Alzheimer’s disease, which have shown promising results.
“Parkinson’s disease, already prevalent among older individuals, is poised to become a much greater public health challenge in coming decades and is commonly understood to also cause cognitive impairment, including dementia,” said A/Prof Macfarlane.
“We are pleased to be able to participate in this important research and to be recruiting Australians as part of it, given the potential for Anavex 2-73 to become a therapy for this unmet need."
Parkinson’s disease patients aged 50 years or older who have been diagnosed with dementia will be recruited for the trial which is also being conducted in other international sites and has received the support of the Michael J Fox Foundation for Parkinson’s Research and León Research.
Trial participants will be randomly assigned to receive orally 30 or 50 mg of Anavex 2-73 or a placebo for 14 weeks.
Researchers will evaluate the impact of the treatment on cognition, as determined by the cognitive drug research computerised assessment system, as well as on patients’ motor function and sleep quality.
Preclinical studies with mouse models of Parkinson’s disease have shown that Anavex 2-73 was able to restore the function of damaged nerve cells and significantly improve motor function.
To express interest in participating in the clinical trial, please contact parkinsonstrial@hammond.com.au.
About Parkinson’s
More than 100,000 Australians are estimated to be living with Parkinson’s disease with as many as 80 per cent eventually experiencing Parkinson’s disease dementia. On average, 37 new cases of Parkinson’s disease are diagnosed every day or about 13,500 per year.
As Parkinson’s prevalence increases threefold after the age of 65, the growth rate innumber of people living with Parkinson’s is expected to increase dramatically as the Australian population ages. It is estimated that the growth rate will average 4% over the next 20 years compared to a general population growth rate of just over 1%.
About HammondCare
HammondCare provides health, aged and dementia care expertise that empowers the people that we serve and is soon to open Victoria’s first, designed-for- purpose, cottage-style dementia care village in Caulfield. Regarded nationally and internationally as one of Australia’s most innovative health and aged care providers, HammondCare offers hospital care, residential care and community services. As an independent Christian charity, HammondCare champions life.
Media information
For information, interviews and cases studies for HammondCare’s Melbourne trial, please contact Peter Hallett on phallett@hammond.com.au or 0418 532 585.
For information, interviews and cases studies for the KaRa MINDS Sydney trial, please contact Agnes Wilson on Agnes.Wilson@anglicare.org.au or 0466 692 098.
Selected Risk Information
BELSOMRA is a prescription medicine for adults who have
trouble falling or staying asleep (insomnia).
It is not known if BELSOMRA is safe and effective in children
under the age of 18 years.
Do not take more BELSOMRA than prescribed.
Do not take BELSOMRA unless you are able to stay in bed a
full night (at least 7 hours) before you must be active again.
Take BELSOMRA within 30 minutes of going to bed.
BELSOMRA may cause serious side effects that you
may not know are happening to you. These side
effects include:
• sleepiness during the day
• not thinking clearly
• acting strangely, confused, or upset
• “sleep-walking” or doing other activities when you are
asleep like eating, talking, having sex, or driving a car.
• Call your doctor right away if you find out that
you have done any of these activities after taking
BELSOMRA.
Do not take BELSOMRA if you fall asleep often at
unexpected times (narcolepsy).
BELSOMRA is a controlled substance because it can be
abused or cause dependence.
Before taking BELSOMRA, tell your doctor about all of
your medical conditions, including if you:
• have a history of depression, mental illness, or
suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have a history of a sudden onset of muscle weakness
(cataplexy)
• have a history of falling asleep often at unexpected
times (narcolepsy) or daytime sleepiness
• have lung or breathing problems
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.
Medicines can interact with each other, sometimes causing
serious side effects. Do not take BELSOMRA with other
medicines that can make you sleepy unless your doctor tells
you to.
Call your doctor if your insomnia (sleep problem) worsens or
is not better within 7 to 10 days. This may mean that there is
another condition causing your sleep problem.
Do not drink alcohol while taking BELSOMRA. It can increase
your chances of getting serious side effects.
Do not drive, operate heavy machinery, do anything
dangerous, or do other activities that require clear thinking
after taking BELSOMRA.
You may still feel drowsy the next day after taking
BELSOMRA. Do not drive or do other dangerous activities
until you feel fully awake.
BELSOMRA may cause serious side effects, including:
• abnormal thoughts and behavior. Symptoms include
more outgoing or aggressive behavior than normal,
confusion, agitation, hallucinations, worsening of
depression, and suicidal thoughts or actions
• memory loss
• anxiety
• temporary inability to move or talk (sleep paralysis) for
up to several minutes while you are going to sleep
or waking up
• temporary weakness in your legs that can happen during
the day or at night.
The most common side effects of BELSOMRA include
drowsiness the next day after you take BELSOMRA
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of BELSOMRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac disorders: palpitations, tachycardia
Nervous system disorders: psychomotor hyperactivity
Psychiatric disorders: anxiety
05/26/19 6:10 PM
Best of luck with your son's sleep issues. One of my nephews has Autism and had sleep issues when younger but has done well as a teenager.
AI
