In January of last year, AnavexTM announced that it would be undertaking a world first Phase 2 clinical trial looking at the efficacy of one of its drugs called Anavex 2-73. This was exciting news, particularly as the trials were being undertaken in Australia. Well, the first lot of results are in and Dementia Daily has the wrap-up for you.
What is Anavex 2-73?
Anavex 2-73 is known as a sigma-1 receptor agonist or in other words has an ability to reduce oxidative stress, protein misfolding, mitochondrial dysfunction and inflammation – commonly noted in the brains of people with Alzheimer’s disease. Animal studies have shown that this treatment is able to reverse memory loss and provide neuroprotection in mice with Alzheimer’s disease.
Director of Aged Psychiatry at Caulfield Hospital and Australian trial lead, Associate Professor Steve Macfarlane said Anavex 2-73 is designed to both relieve symptoms and slow the disease’s progression.
The details of the Australian clinical trials
The Phase 2 clinical trial involved 32 Australians who had been diagnosed with mild to moderate Alzheimer’s disease. The goal of this particular trial was to determine the maximum tolerated dose of the drug, while also assessing participant’s resulting cognitive skill, blood results, and brain scans.
The trial was split into two parts, Part A and Part B. Part A was 5 weeks of on-off-on dosing of Anavex 2-73 via both oral delivery and intravenous injection. Part B of the trial began shortly after, which involved participants taking an oral dose of the treatment daily for 52 weeks.
Preliminary results are in
Due to the relatively low number of participants, the researchers are being cautious with how they are interpreting the results, however the good news is the results do indicate a cognitive benefit associated with taking Anavex 2-73.
After participants underwent a variety of cognitive tests (i.e. Cogstate, MMSE, EEG/ERP), the researchers noted that participants had improvement in psychomotor function (i.e. detection), attention and working memory. Just as importantly, there was no evidence to suggest any major side effects however some participants did have dizzy spells and headaches.
“In addition to the measured cognitive and functional benefits witnessed so far, an overall improvement in mood and decrease in agitation has been anecdotally reported,” Associate Professor MacFarlane said.
At the time of these announcements, Australian media focused on two of the participants who regained ‘lost’ skills. One of whom was able to play the piano again and another who rediscovered her art skills. While this is great news Associate Professor MacFarlane did urge some caution stating “we believe that extending the study will lead us to an increased understanding of the long-term effects of Anavex 2-73.”
The next steps
An Australian ethics committee has approved an extension of this trial designed to allow participants who completed Part B to roll-over into a new trial and continue taking Anavex 2-73 for an additional 104 weeks (or two years), providing an opportunity to gather extended safety and efficacy data.
This trial extension is independent of Anavex’s planned larger Phase 2/3 double-blinded, placebo-controlled study of Anavex 2-73 in Alzheimer’s disease, which is suggested to involve thousands of participants.
Unfortunately, no Australian sites are currently recruiting for Anavex trials and Associate Professor MacFarlane said that “such a study [phase 3 trial] is in the planning phase, and is hoped to commence in 2017.”
Dementia Now will provide updates as soon as they come to hand. In the meantime, you can find out more about Anavex trials at www.anavex.com.
Update - Anavex 2-73 is currently running trials in Parkinson's dementia in Australia and Spain. This will also yield some data on Parkinson's symptoms. They are running Rett Syndrome trials in the U.S. and Australia. This will yield some data on the ability to repair epigenetic disease and seizures. Finally they have begun a P2/3 in Alzheimer's, The first two trials are of short duration so results may be available by the end of the year..... I am hoping that all three groups will begin to sleep better. Sleep is necessary for CNS healing. ......If the data for the first two is positive and all three groups begin sleeping better I am praying that the drug will be approved in Australia for the first two indications. with provisional approval for Alzheimer's and a large P4 study.
I would love to get our sisterinlaw onto the program, my brother inlaw is having a lot of grief trying to get his wife to take part in any outings my wife and I have noticed a lot of detereation in her memory loss over the past couple of years
Hi there, my wife is 68 years old and has vascular dementia since 2 years. Her daily giddiness is shocking, she spends a lot of time in bed because of it and it causes her to fall often. We had her ayes and inner ear tested by doctors but that is not the case.can you give me some advice?
Am I eligible for the trial. I have a good memory now at 76, but search for words when I type. But really, that's all as I make every decision focussing solely on the task. I live near Healesville 3777 Vic.
I wish I can apply for a trial for my mum who is 70 years old in China. She even can't know my dad. How I wish her memory can come back.
I wish I can apply for a trial for my mum in China. She even can't know my dad. How I wish her memory can come back.
The love of my life for the last 17 years was diagnosed with Parkinson's disease nearly 4 years ago, at age 52. He had a stooped posture, tremors, muscle stiffness, horrible driving skills, and slow movement. He was placed on Sinemet 50/200 at night for 7 months and then Sifrol and rotigotine were introduced which replaced the Sinemet but he had to stop due to side effects. He started having hallucinations, lost touch with reality. Suspecting it was the medications I took him off the Siferol (with the doctor's knowledge) In March this year his primary physician suggested we started him on Natural Herbal Gardens Parkinson’s Herbal formula which eased his anxiety a bit, i’m happy to report this PD herbal treatment worked very effectively. His Parkinson’s is totally under control, he had a total decline in symptoms, the tremors, shaking, stiffness, slow movement and speech problems stopped. Visit Natural Herbal Gardens official web page ww w. naturalherbalgardens. c om. My family are amazed at the change and rapid improvement. This herbal treatment is a breakthrough for all PD sufferers. SHARE WITH FRIENDS!!
i would luv to do this for my father please ,,,,he has dementia,,,and in nursing home he is 93 this August15,,,it would be a nice birthday present if he could be helped ,,,even if its just a trial...his name is Euripides,,,
How can I determine whether I am on my way to having dementia? I am a 76 y.o. male who sometimes experiences occasional memory loss.
My mum 82 has been recently diagnosed with vascular dementia. Symptoms became apparent when her beloved son in law died in April. She repeats things constantly, says she's spoken to people the other day when these people have died years ago. She gets muddled with names. She ran her own 12 hour day business up to 76 years old and to see this now is gut wrenching in particular with dad whom she gets annoyed with easily when he tries correcting her. Geriatric specialist says there's no meds to give her to make it better or stable. I do not believe him quite frankly. She's taking organic coconut oil daily as I've read that triglycerides are helpful for the past month. I've also read that cannabis is fabulous but unfortunately it's illegal here. Today on the news they say there was a breakthrough in reversing dementia with type 2 diabetes meds. It will be available shortly. Shortly to them is 2 years! In 2 years so many people will suffer more!! Is there a trial my mum get into? Or is it a case of illegally alive or legally dead as per cancer patients that won't be prescribed cannabis oil to kill cancer cells in a lot of cases or at lease ease others pain? People will go to extreme lengths to help their loved ones as you'd know be it legally or illegally.
Hi Warren Please know you are not alone. If ever you need any information, advice or support on dementia, we have dementia advisors who can assist you on our free National Dementia Helpline on 1800 100 500 Monday - Friday, 9am-5pm. All the best Leanne - The Dementia Daily team
I took Mum in for a trial a while ago but she just missed by a point or two on the cognitive scale and therefore missed out. I am encouraged by the feedback I hear but fear it will be too late for her. I know this all takes time but I fear that she will be lost to us before these trials finish. All of us in my family would grab on to any chance to even stabilize her condition, let alone improve it. Surely there is merit in seeing the results of the drug for people with advanced conditions.
Hi Connie Thank you for contacting us. Know that you are not alone - we have a team of wonderful counsellors on the free National Dementia Helpline who are here to help you on 1800 100 500. They are available from 9am-5pm Monday-Friday. You can also contact them via webchat via this link https://www.fightdementia.org.au/helpline/webchat. Kind regards Leanne – The Dementia Daily Team
It is so painful to sit and do nothing, just watching and waiting until he is all gone. The Anavex 2-73 trials sound so promising. But the clock is ticking. He looked at a dinner menu the other day and asked me what pasta is. He has degrees from two private universities, a wordsmith, and is known for his command of the language. Pasta: "A dish originally from Italy consisting of dough made from durum wheat and water, extruded or stamped into various shapes and cooked in boiling water."
Hi Leon, I'm not sure, I'm sorry. Might be worth contacting the company conducting the drug trial about that. You can also call our advisors on the National Dementia Helpline on 1800 100 500 for information, support and advice. Thanks, The Dementia Daily Team
Should all go well with the Anavex 2-73 trials,how long would it be before people suffering with Alzheimers could have access to this drug.My mum has a moderate Alzheimer condition for 2.5 years now and would she be in time to be saved.Thank you.
Hi Jen, I understand this is just being trialled in relation to Alzheimer's disease. I don't know if this will help with people with Parkinson's disease. If you would like to know more, perhaps you could go to their website www.anavex.com. Good luck, The Dementia Daily Team
Will this be able to help Parkinson's patients too? Both cognition and mobility?
Hi Robyn, The email we've been given by the clinical trial team is firstname.lastname@example.org. Hopefully this works? Let us know if it doesn't. The team at the National Dementia Helpline is also available to talk to you, if you would like. You can call them on 800 100 500, Monday-Friday from 9am-5pm. Good luck, The Dementia Daily Team
Could you please check the email address if Avanex Drug Trial. My husband has been diagnosed with Alzheimer's and at present taking Aricept with good results. I tried to email the researchers o. The email address but it came back as a bad destination. I have only just found your website and I am finding the information very helpful. Thank-you Robyn
Those with advanced Alzheimer's or Dementia, aren't being considered for trials ..why not ? I cant speak with certainty for mum, but believe she would whole heartedly grab any opportunity no matter how small to potentially improve her prospects, and others who are yet to experience this disease She'd probably say she has nothing to loose (the disease having already significantly diminished her health, emotionally & importantly the quality of her life ..not to mention the impact on family & friends) and would accept any chance this can be improved ..and we the family would advocate for this opportunity for her ! So bring on some 'last chance trials'
Hi Graeme. I'm not sure we can answer that one for you, sorry. Kind regards, The Dementia Daily Team
Be interesting to know if would be beneficial to those diagnosed with Autonomic Dysfunction?
Hi Rhonda. Thanks for your comment. I am sorry to hear about your husband - that must be very distressing. As you would be aware, euthanasia is not legal in Australia. However, Alzheimer's Australia does advocate for people to receive the very best end of life care possible, to reduce pain and alleviate the symptoms associated with end of life and dying. Please do know that you can call our dementia advisors on the National Dementia Helpline on 1800 100 500 for support and guidance on advanced dementia. All the best. The Dementia Daily Team
Hi Mahdi, The best option is to email them. That's the preferred point of contact we've been given to give out to anyone who is interested in the trial. Here it is email@example.com. You can also call our dementia advisors on the National Dementia Helpline. They can let you know about other supports or services that may be of help to you and your family. Good luck. The Dementia Daily Team
Hi my husband was diagnosed 8 yrs ago with dementia. I know and understand that he is well and truly past the post of no return. I just want to say that it grieves my heart more to watch him waste away...sitting doing nothing. I hope and pray that this new drug will help to cure or slow down the process. I believe that also there should be a moment when a decision should and be able to be made to end life. My sons and i suffer enough seeing our father/husband this way, he is in a virtual vegetated state and only 60.
my father has alzheimer's disease symptoms and he lives in overseas . is it any other option to communicate with trial team or just send an email? i live in Melbourne can i meet them in Monash University or any clinic ?
Hi Wendy, The Australian Clinical Trials website is a good place to start. Here's the link https://www.australianclinicaltrials.gov.au/how-be-part-clinical-trial You can also call our Helpline to discuss it further with a dementia advisor on 1800 100 500. Good luck. The Dementia Daily Team.
How does someone become apart of a trial ?
My mother in law has been treated with Alzheimer's for five years . Although she is getting much shorter memory she is still able to cook run a house and look after her own personal daily living activities. Her mobility and balance is better than mine . It would just be nice for her to remember west she asked two minutes before She is in Sydney
Hi Wendy. It does look like it is targeted to people with Alzheimer's disease, however, it would be best to contact the National Dementia Helpline and talk to one of our dementia advisors about this. They would be able to point you in the right direction. You can contact them on 1800 100 500. Good luck.
Hi, my mum has FTD Dementia, is this something that might help her? We would really like to be able to give it a try
Like you MJ I have someone close to me (my mother) with dementia and wish there was something to give my mother that would make her better or stop the decline. I hope the people in the current Anavex study continue to have relatively stable levels of cognition for a long time and that Anavex continues to extend the trial for these people. If the company thinks they have the dose right or has say 2 doses to try out then I (as a layman) think that the planned random controlled trial with placebos and a large enough treatment group is the way to go in order to get the drug approved to benefit the largest number of people. So for now all we can do is hope that such a trial starts soon and is available in multiple countries including our countries. I am in Canada and I assume you are in the US. Of course that would mean that our loved ones if they successfully enrol in the trials would only have a 50% chance of getting the treatment, but after some trials all patients are allowed to take the real drug, For your grandfather I have noticed that there is a trial of Transcranial Magnetic Stimulation in New Jersey. According to the description “TMS leads to increased secretion of brain-derived neurotrophic factor (BDNF), a protein in the brain and spinal cord that promotes nerve-cell survival and growth. TMS is a non-invasive treatment with no significant side effects.” The website for the trial is at https://www.nia.nih.gov/alzheimers/clinical-trials/transcranial-magnetic-stimulation-treat-alzheimers. At the top of the webpage it says “No longer recruiting” although that conflicts with the status later on the page. The TMS technique is not something that I have researched in depth; I am just mentioning it as an option for your grandfather that is low risk. There is contact information at the URL I gave. There is also another website http://www.brainsway.com/alzheimers-disease for a company using TMS that is located in New Jersey. Being in New Jersey, there would probably be other clinical trials using techniques other than TMS available for your grandfather.
Silly question, for patients like my grandfather who literally have such short term memory they don't even remember that they took anything and that they have the condition, do you really need the control group. If I could have my grandfather back for even a short period of time i would take that chance. You bring that drug to NJ any time your ready. xo God Bless
Hi Prof Nimal. I am sorry to hear about your wife. If you live in Australia, you can call the National Dementia Helpline for free on 1800 100 500 for information, assistance and advice. If you live in Sri Lanka, perhaps the local Alzheimer's Association could be of assistance? Thank you, The Dementia Daily Team
Very helpful. My wife has dementia. I have been trying many options available in Sri Lanka but with little progress. I would appreciate it very much if you could help my wife.
Hi Sarita. Do you live in Australia? I would suggest calling the National Dementia Helpline on 1800 100 500 as a good first step. You can also contact them via email on firstname.lastname@example.org. Good luck/ The Dementia Daily Team
My sister has Alzheimer for the past 3 years. She understands everything to talk to her. She knows who she has to talk in english and she talks to me in spanish. I've been trying to find something that can help her get better. Do you think that you can help us please.
Hi Jenny. Best to go straight to the people that are conducting the clinical trials if you'd like to find out more. You can contact them via this email: email@example.com. Thanks, The Dementia Daily Team
I would like to apply for the trail for my dad in China, I can't go back to china to look after him but I wish I can do something for him, my grandmother died of AD.
Given the predicted numbers of people expected to develop Alzheimers in the future, surely our government needs to support this trial in order fast track the results. My sister was diagnosed with Alzheimers a year ago and has relatively minor cognitive impairment which seems to have stabilised. I believe this is due to the inclusion of specific fats and oils, and extra protein into her diet. I WILL not sit back and watch my sister deteriorate and believe we ALL need to make this an election issue.
These results are encouraging but must be treated with great caution. A study with no control group and very small numbers means there is a significant possibility the results could simply reflect the psychological benefits of being in a drug trial and the extra attention and greater interest in life that produces.