green tea new orleans reviews

How Alzheimer’s drug breakthrough opens the door for two MORE experimental treatments that could yield results in MONTHS — after decades of failed trials

  • Lecanemab became first drug ever shown to slow progress of Alzheimer’s today
  • It has reignited hopes that targeting amyloid beta is key to treating the disease
  • Two other drugs that work in same way are in trials and results expected winter

A breakthrough treatment that slows Alzheimer’s disease has boosted scientists’ hopes for two more experimental drugs, scientists said Wednesday. 

Lecanemab, which is given as an injection every two weeks, was found to slow the progress of Alzheimer’s disease in patients by 27 per cent.

It makes it the first ever drug shown to arrest the progression of the condition, cialis pils putting an end to decades of failed trials.

The breakthrough has reignited hopes that targeting a particular protein is key to treating the fatal brain disease. 

And it now gives a huge boost to studies of similar drugs being run by pharmaceutical companies Roche and Eli Lilly — which may start to yield results within months.

The makers of lecanemab — Tokyo-based firm Eisai and US pharma giant Biogen — called their breakthrough a ‘historic moment’.

Their drug works by removing of sticky deposits of a protein called amyloid beta from the brains of people with Alzheimer’s, delaying the progression of symptoms.

Nearly all Alzheimer’s drugs until now, including those targeting amyloid, have stumbled in trials.

Dr Kristian Steen Frederiksen, director of a clinical trial unit at the University of Copenhagen, said the latest data was solid evidence the plaque is not just an ‘innocent bystander’ in the development of dementia drugs.

Other high-profile anti-amyloid drugs, including Roche’s gantenerumab and Eli Lilly’s donanemab, are higher as a result of today’s breakthrough, analysts said.

An experimental Alzheimer’s drug, called lecanemab, has significantly slowed cognitive and functional decline by 27 per cent in a large patient trial (stock) 

A study by researchers at the University of Washington School of Medicine published last year revealed that global dementia cases are set to nearly triple by 2050, from 57.4million to 152.8million. But the rate of illness is expected to increase varies between different parts of the world. In Western Europe, cases are expected to rise by just 75 per cent, mainly due to an ageing population, while they are expected to double in North America. But the biggest rise is expected to be seen in North Africa and the Middle East, with cases up by 375 per cent


The other drugs in development are gantenerumab being made by Eli Lilly (left) and donanemab being made by Swiss pharmaceutical giant Roche (right) 

‘Investor expectations (for rival studies) will certainly rise, as very few would assign a likelihood of success >50 per cent for these trials considering the graveyard of past failures,’ said Daniel Chancellor, healthcare analyst at Citeline.

Late-stage data on gantenerumab is expected by the fourth quarter, Roche said in a statement, saying it was encouraged by the lecanemab data.

Lilly said it remained confident in its donanemab development programme. Results of a key late-stage trial testing the drug are anticipated by mid-2023.

Alzheimer’s researchers have suggested success for one or more of the three drugs is likely to invigorate research across the entire field, if the results withstand scrutiny.

Biogen’s stock surged 35.4 per cent in early US trading while shares of Eisai jumped 17 per cent to the daily limit in Tokyo. Lilly and Roche’s stock rose between 6 per cent and 7 per cent.

Everything you need to know about ‘breakthrough’ Alzheimer’s drug lecanemab 

What does it do?

Lecanemab is a drug that is injected bi-weekly to those suffering from early Alzheimer’s.

The antibody treatment, created by Japanese and US pharmaceutical giants Eisai and Biogen, combats the build-up of plaque in the brain, which is thought to be behind Alzheimer’s.

What did trials show? 

The Phase III trial of lecanemab evaluated the drug’s ability to reduce cognitive and functional decline among 1,795 patients with early Alzheimer’s.

Half of participants were given 10mg/kg of the drug bi-weekly, while the others were given a placebo drug. 

Researchers measured participants’ memory, judgment, problem solving and judgement before they started taking the drug or placebo and again 18 months later.

Results showed that those given lecanemab saw their mental condition decline 27 per cent less than those given the dummy treatment.

The lecanemab group also experienced a slower build up of amyloid levels in the brain, scans showed.

Is the drug dangerous?

As well as promising results, clinical trials also flagged safety concerns. 

Brain swelling and micro hemorrhages were spotted among 21.3 per cent in the lecanemab group and 9.3 per cent in the placebo group. 

The pharma giants said the figures fall within an expected range.

And one patient in the US reportedly died while taking lecanemab during clinical trials, after suffering a brain bleed. 

However, Eisai and Biogen noted that all available safety information shows the therapy is not linked with an increased risk of death.

How close is it to being rolled out?

The drugmakers are seeking approval for lecanemab from the US Food and Drug Administration, with a decision expected in early January.

The companies say they will also submit their findings to regulators in Japan and Europe to by April 2023.

However, watchdogs will then need to assess whether the drug is safe and effective before making a decision, so it is unclear when the treatment could be rolled out.

How is it different to similar drug Aduhelm?

Both Aduhelm and lecanemab — which are both made by Eisai and Biogen — are antibodies designed to remove amyloid deposits. 

However, lecanemab targets amyloid that has not yet clumped together, while Aduhelm removed amyloid plaques that built up in the brain.

Aduhelm’s approval was a rare bright spot for Alzheimer’s patients, but critics have warned about the underwhelming results of the drug and highlighted its risks.

Some researchers, including Frederiksen, are cautiously optimistic about the impact the Biogen and Eisai data has on the likelihood of success for the other two drugs in development.

The three experimental drugs differ in terms of which types of amyloid beta they bind to, and there are differences in trial designs, and potentially safety profiles, he said.

‘We’ve learned lately not to get our hopes up too much,’ said Tara Spires-Jones, deputy director of the Centre for Discovery Brain Sciences at the University of Edinburgh.

Scientists also caution there are many brain changes implicated in Alzheimer’s in addition to amyloid, and that some of the other targets being explored are more likely to work for people who have established dementia.

Alzheimer’s is a complex disorder, and only targeting amyloid may not be enough, said Miia Kivipelto, professor of clinical geriatrics at the Karolinska Institutet, Center for Alzheimer Research.

An individualized treatment approach as is the case with cancer is likely needed, she said.

The so-called amyloid hypothesis has been challenged by some scientists, particularly after the U.S. Food and Drug Administration’s controversial approval of Aduhelm in 2021 based on its plaque-clearing ability rather than proof that it helped slow cognitive decline. The decision came after the FDA’s own panel of outside experts had advised against approval.

‘This (latest data) will certainly make the strongest proponents of the amyloid hypothesis very happy and may dampen the arguments of the strongest critics,’ said Spires-Jones.

Today’s announcement comes after the hugely controversial medical approval of the pair’s other similar Alzheimer’s drug last year.

Aduhelm, which also tackles amyloid accumulation in the brain, was given the green light based on its ability to clear the protein from the brain — rather than proof that it prevented the disease from worsening.

Some scientists warned Aduhelm failed to live up to the hype, with studies showing it improved mental capacity by less than one per cent. The £26,000-a-year ($28k) drug has even been linked to deaths.

Its case highlighted the controversy surrounding the technique of clearing amyloid. 

Today’s results on lecanemab come from a Phase III trial involving 1,795 patients with early Alzheimer’s.

It is the third and final test of a drug’s safety and effectiveness before it is submitted to regulators to consider.

Half of participants were given 10mg/kg of the drug bi-weekly. Others were given a placebo. 

Researchers measured the participants’ memory, judgment and problem solving skills before the trial began, and again 18 months later.

Results showed those given lecanemab saw their mental condition decline 27 per cent less than those given the dummy treatment.

The lecanemab group also experienced a slower build up of amyloid levels in the brain, scans showed.

However, substantial side effects were also detected. 

Brain swelling was spotted among 12.5 per cent of the lecanemab group, compared to 1.7 per cent in the placebo group.

While the side effect showed up on scans, many of these cases were not symptomatic, Eisai and Biogen insisted.

Symptomatic brain swelling was seen in 2.8 per cent of those in the lecanemab group and none of the placebo group, results show.

The trial also tracked the rate of micro-haemorrhages in the brain, or mini brain bleeds.

Data showed these occurred among 17 per cent in the lecanemab group and 8.7 per cent of the placebo group.

The pharma giants said the figures fall within an expected range.

Eisai is seeking approval for lecanemab from the US Food and Drug Administration, with a decision expected in early January.

The medicine, lecanemab, is being developed by Biogen and Eisai, the same two pharmaceutical companies behind Aduhelm

The company said it will also submit data to regulators in Japan, the UK and Europe by April, who will then independently need to assess whether the drug is safe and effective.

Dr Susan Kohlhaas, director of research at Alzheimer’s Research UK, said the results are a ‘historic moment’ and a ‘major breakthrough in dementia research’.

She said that while lecanemab is the first drug shown to remove amyloid in the brain and reduce cognitive decline, it can also trigger ‘substantial side effects’ which will need to be considered. 

Dr Kohlhaas said: ‘These top-line results, announced by the pharmaceutical company that make the drug, Eisai, offer new hope to people affected by this cruel and devastating disease.’

If regulators approve lecanemab, it is ‘essential’ that it is dished out to those who may benefit from it ‘as quickly as possible’, she said.

Dr Kohlhaas added: ‘This drug has only been tested for people in the early stages of Alzheimer’s and won’t be a silver bullet for all causes of dementia. 

‘We hope today’s news will spark renewed investment in dementia research across the globe and political leadership to deliver the funding and infrastructure needed to make life-changing new treatments a reality.’

WHAT IS ALZHEIMER’S?

Alzheimer’s disease is a progressive, degenerative disease of the brain, in which build-up of abnormal proteins causes nerve cells to die.

This disrupts the transmitters that carry messages, and causes the brain to shrink. 

More than 5 million people suffer from the disease in the US, where it is the 6th leading cause of death, and more than 1 million Britons have it.

WHAT HAPPENS?

As brain cells die, the functions they provide are lost. 

That includes memory, orientation and the ability to think and reason. 

The progress of the disease is slow and gradual. 

On average, patients live five to seven years after diagnosis, but some may live for ten to 15 years.

EARLY SYMPTOMS:

  • Loss of short-term memory
  • Disorientation
  • Behavioral changes
  • Mood swings
  • Difficulties dealing with money or making a phone call 

LATER SYMPTOMS:

  • Severe memory loss, forgetting close family members, familiar objects or places
  • Becoming anxious and frustrated over inability to make sense of the world, leading to aggressive behavior 
  • Eventually lose ability to walk
  • May have problems eating 
  • The majority will eventually need 24-hour care   

 Source: Alzheimer’s Association

Source: Read Full Article