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Title: Could this be the end of Alzheimer's? Revolutionary drug 'may stop the disease from ever developing'
Source: Daily Mail Online
URL Source: http://www.dailymail.co.uk/health/a ... lear-toxic-proteins-brain.html
Published: Aug 31, 2016
Author: Fiona MacRae
Post Date: 2016-08-31 21:12:30 by cranky
Keywords: None
Views: 4962
Comments: 27

  • Aducanumab is designed to target the underlying damage to the brain
  • Works by targeting the hallmark tangle of proteins in Alzheimer's patients
  • Study showed those who took drug had reduced build up after a year
  • Experts hailed the findings as 'game-changing' and 'unprecedented'

A revolutionary drug that could stop people from ever developing Alzheimer’s disease has been unveiled by scientists.

Trials have produced ‘unprecedented’ results and the medicine has been hailed as a potential game-changer in the fight against the cruel disease.

In future, healthy pensioners could be prescribed the drug to ward off dementia, in much the same way as statins are given today to those at risk of heart attacks.

One British expert described the drug, which is about to be tested in hospitals around the UK, as the best yet, others called it ‘ingenious’ work with ‘tantalising’ results.

And a US doctor hailed it as the best news in his 25-year career.

The revolutionary drug, aducanumab, could stop people from developing Alzheimer’s disease

The revolutionary drug, aducanumab, could stop people from developing Alzheimer’s disease

Alzheimer’s and other forms of dementia affect some 850,000 Britons, with one new case every three minutes.

Existing drugs are of limited benefit and despite billions of pounds being spent on research, no new medicines have hit the market in more than a decade.

While current therapies ease the symptoms, aducanumab tackles the underlying damage in the brain, raising hopes it will be the first to alter the course of the disease.

It contains an antibody that homes in on amyloid, the protein that clogs the brain in Alzheimer's, poisoning and killing the cells.

In preliminary trials, involving 165 people in the early stages of the disease, the Swiss-designed drug triggered the removal of amyloid from the brain.

And in men and women given a monthly infusion of a high dose of the drug, the amyloid all but vanished after a year.

This ‘unprecedented’ effect was deemed so significant that the results have been published in Nature the world’s top science journal.

The new drug has been found to get rid of clumps of the amyloid protein are a hallmark of Alzheimer's and are thought to be harmful to brain cells

The new drug has been found to get rid of clumps of the amyloid protein are a hallmark of Alzheimer's and are thought to be harmful to brain cells

WHAT THE EXPERTS SAY

Professor Richard Morris, of Edinburgh University

The importance of this first step cannot be understated

Professor David Allsop, of the University of Lancaster

These findings could be a “game-changer”

Dr James Pickett, head of research at the Alzheimer’s Society

These results are the most detailed and promising that we’ve seen for a drug that aims to modify the underlying causes of Alzheimer’s disease.

Dr David Reynolds, chief scientific officer of Alzheimer’s Research UK

These results provide tantalising evidence that a new class of drug to treat the disease may be on the horizon.

Professor John Hardy, University College London

These new data are tantalising

Professor Stephen Salloway (CORR), of the Butler Hospital in Rhode Island

This is the best news I’ve had in my 25 years of doing Alzheimer’s research.

Professor Roger Nitsch (CORR), of the University of Zurich

The effect of this drug is unprecedented.

US researcher Stephen Salloway, of the Butler Hospital in Rhode Island said: ‘This is the best news I’ve had in my 25 years of doing Alzheimer’s research.

‘It brings new hope to the patients and families most affected by this disease.’

Even more excitingly, the drug seemed to halt the disease.

Men and women who weren’t treated experienced steady declines in memory and day to day functioning, such as the ability to cook for themselves or take out the rubbish but those given high doses of the drug stopped getting any worse after just six months of treatment.

The number of people tested was too small to be sure the drug can really stop the disease in its tracks and a larger trial, involving 2,700 people in the early stage of Alzheimer’s, is underway.

Hospitals and clinics in eight British cities, including London, Newcastle, Glasgow, Edinburgh and Dundee are taking part and are looking for patients.

The trial is due to finish in 2020 and, if aducanumab is deemed safe and effective, it could be available shortly afterwards.

However, there are several hurdles to overcome.

Drugs that have seemed promising when given to small groups of people can fail spectacularly when tested on large numbers.

Plus, aducanumab can cause a worrying side-effect, in which fluid accumulates in the brain, raising the risk of strokes.

Challenges include finding a dose that is high enough to work but not so powerful that it does damage.

Other amyloid-busting antibodies have been tried before.

But aducanumab, which is based on antibodies naturally made by pensioners who seem to be immune to Alzheimer’s, is said to be the best yet.

It is thought it is better at getting into the brain and more likely to zero in on the damaging amyloid than previous drugs.

Aducanumab is a type of therapy called an antibody, designed to target the amyloid protein in patientsin the early stages of Alzheimer's

Aducanumab is a type of therapy called an antibody, designed to target the amyloid protein in patientsin the early stages of Alzheimer's

In future, aducanumab, which was originally developed at the University of Zurich, could be given to seemingly healthy pensioners, in a bid to keep them going on to develop Alzheimer’s.

People could be given brain scans in their 60s and 70s and those thought to be at risk of dementia given the drug.

Today, some 15 per cent of 65-year-olds have a build-up of amyloid but are still symptom-free.

Alfred Sandrock, of Biogen, the US drug company developing the drug, said: ‘I could imagine a time when we would treat people before they have symptoms.

‘We do that now, for example we treat people with high cholesterol before they get heart disease because we would like to prevent heart disease.’

Experts cautioned that it is too early to be certain that aducanumab works. However, the early results have caused huge excitement.

Richard Morris, a professor of neuroscience at Edinburgh University, said: ‘The importance of this first step cannot be understated.

‘Let’s keep our fingers crossed for success in the next steps.’

Professor David Allsop, of the University of Lancaster, said: ‘These findings could be a “game-changer” if the effects on memory decline could be confirmed.’

Dr James Pickett, head of research at the Alzheimer’s Society, said: ‘These results are the most detailed and promising that we’ve seen for a drug that aims to modify the underlying causes of Alzheimer’s disease.’

Dr David Reynolds, chief scientific officer of Alzheimer’s Research UK, said: ‘These results provide tantalising evidence that a new class of drug to treat the disease may be on the horizon.

‘It has been over a decade since the last drug was licensed for use in people with Alzheimer’s and there are currently no treatments able to stop the disease in its tracks.’ (3 images)

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Begin Trace Mode for Comment # 24.

#2. To: cranky (#0)

In preliminary trials, involving 165 people in the early stages of the disease, the Swiss-designed drug triggered the removal of amyloid from the brain.

So does THC, by the by.

ConservingFreedom  posted on  2016-08-31   22:26:33 ET  Reply   Untrace   Trace   Private Reply  


#3. To: ConservingFreedom, cranky (#2)

In preliminary trials, involving 165 people in the early stages of the disease, the Swiss-designed drug triggered the removal of amyloid from the brain.

So does THC, by the by.

DEA, Docket DEA-427, Denial to Petition To Initiate Proceedings To Reschedle Marijuana, Fed. Reg. Vol. 81, No. 156 (12 August 2016) page 53776

Cardiovascular and Autonomic Effects

Single smoked or oral doses of delta9-THC produce tachycardia and may increase blood pressure (Capriotti et al., 1988; Benowitz and Jones, 1975). Some evidence associates the tachycardia produced by delta9-THC with excitation of the sympathetic and depression of the parasympathetic nervous systems (Malinowska et al., 2012). During chronic marijuana ingestion, a tolerance to tachycardia develops (Malinowska et al., 2012).

However, prolonged delta9-THC ingestion produces bradycardia and hypotension (Benowitz and Jones, 1975). Plant-derived cannabinoids and endocannabinoids elicit hypotension and bradycardia via activation of peripherally-located CB1 receptors (Wagner et al., 1998). Specifically, the mechanism of this effect is through presynaptic CB1 receptor-mediated inhibition of norepinephrine release from peripheral sympathetic nerve terminals, with possible additional direct vasodilation via activation of vascular cannabinoid receptors (Pacher et al., 2006). In humans, tolerance can develop to orthostatic hypotension (Jones, 2002; Sidney, 2002) possibly related to plasma volume expansion, but tolerance does not develop to the supine hypotensive effects (Benowitz and Jones, 1975). Additionally, electrocardiographic changes are minimal, even after large cumulative doses of delta9-THC are administered. (Benowitz and Jones, 1975).

Marijuana smoking by individuals, particularly those with some degree of coronary artery or cerebrovascular disease, poses risks such as increased cardiac work, catecholamines and carboxyhemoglobin, myocardial infarction, and postural hypotension (Benowitz and Jones, 1981; Hollister, 1988; Mittleman et al., 2001; Malinowska et al., 2012).

nolu chan  posted on  2016-08-31   23:54:40 ET  Reply   Untrace   Trace   Private Reply  


#5. To: nolu chan (#3)

So THC has negative side effects - does aducanumab have none? Ought we ban all medicines with negative side effects?

ConservingFreedom  posted on  2016-09-01   11:21:41 ET  Reply   Untrace   Trace   Private Reply  


#7. To: ConservingFreedom (#5)

So THC has negative side effects - does aducanumab have none? Ought we ban all medicines with negative side effects?

One of those side effects being myocardial infarction.

Aducanumab is in the clinical trial stage.

Test marijuana, submit your results, and get approved.

For marijuana, note that "[c]urrently, no published studies conducted with marijuana meet the criteria of an adequate and well-congroled efficacy study." FR 53780.

Fed. Reg. 53780, August 12, 2016

The PubMed search yielded a total of 566 abstracts of scientific articles. Of these abstracts, a full-text review was conducted with 85 papers to assess eligibility. Of the studies identified through the search of the references and the 566 abstracts from the PubMed search, only 11 studies met all the criteria for selection (Abrams et al., 2007; Corey-Bloom et al., 2012; Crawford and Merritt, 1979; Ellis et al., 2009; Haney et al., 2005; Haney et al., 2007; Merritt et al., 1980; Tashkin et al., 1974; Ware et al., 2010; Wilsey et al., 2008; Wilsey et al., 2013). These 11 studies were published between 1974 and 2013. Ten of these studies were conducted in the United States and one study was conducted in Canada. The identified studies examine the effects of smoked and vaporized marijuana for the indications of chronic neuropathic pain, spasticity related to Multiple Sclerosis (MS), appetite stimulation in human immunodeficiency virus (HIV) patients, glaucoma, and asthma. All studies used adult subjects.

The 11 identified studies were individually evaluated to determine if they successfully meet accepted scientific standards. Specifically, they were evaluated on study design including subject selection criteria, sample size, blinding techniques, dosing paradigms, outcome measures, and the statistical analysis of the results. The analysis relied on published studies, thus information available about protocols, procedures, and results were limited to documents published and widely available in the public domain. The review found that all 11 studies that examined effects of inhaled marijuana do not currently prove efficacy of marijuana in any therapeutic indication based on a number of limitations in their study design; however, they may be considered proof of concept studies. Proof of concept studies provide preliminary evidence on a proposed hypothesis involving a drug’s effect. For drugs under development, the effect often relates to a short-term clinical outcome being investigated. Proof of concept studies often serve as the link between preclinical studies and dose ranging clinical studies. Thus, proof of concept studies generally are not sufficient to prove efficacy of a drug because they provide only preliminary information about the effects of a drug.

nolu chan  posted on  2016-09-02   18:40:24 ET  Reply   Untrace   Trace   Private Reply  


#8. To: nolu chan (#7)

Test marijuana, submit your results, and get approved.

I say, leave medical decisions to doctors in consultation with patients.

ConservingFreedom  posted on  2016-09-02   20:39:42 ET  Reply   Untrace   Trace   Private Reply  


#9. To: ConservingFreedom (#8)

I say, leave medical decisions to doctors in consultation with patients.

I say, that's not what the law says. If you dislike the law, work to change the law.

As for doctors, they have already proven that they will prescribe marijuana for patients they have either not fully evaluated, or whom they have not met at all.

nolu chan  posted on  2016-09-02   22:44:11 ET  Reply   Untrace   Trace   Private Reply  


#10. To: nolu chan (#9)

If you dislike the law, work to change the law.

Will I have your support?

As for doctors, they have already proven that they will prescribe marijuana for patients they have either not fully evaluated, or whom they have not met at all.

Doctors have misprescribed opiate painkillers - shall we ban those too?

ConservingFreedom  posted on  2016-09-02   22:59:06 ET  Reply   Untrace   Trace   Private Reply  


#12. To: ConservingFreedom (#10)

If you dislike the law, work to change the law.

Will I have your support?

I will support your efforts to meet the legal requirements. The only lawful possession is for federally authorized research. Other than that, marijuana (including so-called medical marijuana) is illegal in any quantity in all 52 federal jurisdictions, which includes all 50 states.

If you can get the federal law changed, I will acknowledge your achievement if I live that long. Citizen proposals that become state laws have no legal effect if they conflict with federal law.

A big opponent may be the alcohol lobby and the tax man. Think of what legal pot would do to alcohol sales and taxes.

If you can change the law, and make marijuana legal like alcohol, be prepared for what happened to alcohol when prohibition ended. No one will be allowed to grow and sell to individuals or retailers. All sales will go to licensed distributors. That was how government weeded (extra credit for word play) out mobsters from legitimate businesses. A very significant federal marijuana tax will be reinstated. The tax only stopped when marijuana was declared illegal. There is no taxing of a substance that is illegal to possess.

The relatively small pot farms will be inundated with regulations, making pot cultivation expensive. They will need paper shufflers and accountants. The costs of doing business will force them to succumb to big farming. Give it time and you will have Monsanto pot. Plan on government taxing at a rate to maintain revenue.

I do not personally care if you smoke so much pot that Willie Nelson gets high off your secondary smoke. That would not extend to driving stoned on a public road, or running about with gun while seriously impaired.

As for getting approval of marijuana for medical use, the first major hurdle to get over is:

i. the drug’s chemistry must be known and reproducible

"The substance’s chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement."

See Fed. Reg. 81-156, 12 Aug 2016 at 53779.

As for doctors, they have already proven that they will prescribe marijuana for patients they have either not fully evaluated, or whom they have not met at all.

Doctors have misprescribed opiate painkillers - shall we ban those too?

We should take the licenses of those doctors and put them in prison. They have committed crimes and created drug addicts.

Usually, they at least see the patient. Pot scrips have been written for patients never seen, much less evaluated. The substance is illegal, the scrip is illegal, the doctor is committing a criminal act, and the patient may wind up prosecuted for unlawful possession.

Many doctors have misprescribed antibiotics for the common cold. About all they accomplish is to facilitate growing superbugs. It should be stopped, but it is not an argument for or against marijuana.

nolu chan  posted on  2016-09-03   18:45:43 ET  Reply   Untrace   Trace   Private Reply  


#13. To: nolu chan (#12)

"Will I have your support?"

If you can get the federal law changed, I will acknowledge your achievement if I live that long.

Not what I asked. Will you answer the question I asked?

"Doctors have misprescribed opiate painkillers - shall we ban those too?"

We should take the licenses of those doctors and put them in prison. They have committed crimes and created drug addicts.

Again, not what I asked. Will you answer the question I asked?

it is not an argument for or against marijuana.

I never said nor implied it was; but if misprescribing antibiotics or opiate painkillers is not an argument for banning those drugs, then misprescribing marijuana is not an argument for banning that drug.

ConservingFreedom  posted on  2016-09-03   19:09:02 ET  Reply   Untrace   Trace   Private Reply  


#15. To: ConservingFreedom (#13)

Will I have your support?

I will support your efforts to meet the legal requirements.

That's was your answer. If you want to select something from another paragraph down, that is your choice.

if misprescribing antibiotics or opiate painkillers is not an argument for banning those drugs, then misprescribing marijuana is not an argument for banning that drug.

Medicines are legal, marijuana is not. Misprescribing legal opiate painkillers does nothing to make marijuana legal. Your bullshit is just bullshit.

nolu chan  posted on  2016-09-03   20:18:55 ET  Reply   Untrace   Trace   Private Reply  


#17. To: nolu chan, conserving freedom (#15)

"Doctors have misprescribed opiate painkillers - shall we ban those too?" ---- if misprescribing antibiotics or opiate painkillers is not an argument for banning those drugs, then misprescribing marijuana is not an argument for banning that drug. -- C.F.

nolu sham --- Medicines are legal, marijuana is not. Misprescribing legal opiate painkillers does nothing to make marijuana legal.

Incredibly silly circular reasoning.

--- This clown pretends to be a legal expert, posting page after page of court opinions, yet he reasons like a grade school dropout. -- Pitiful display.

tpaine  posted on  2016-09-03   23:33:14 ET  Reply   Untrace   Trace   Private Reply  


#20. To: tpaine (#17)

This clown pretends to be a legal expert, posting page after page of court opinions, yet he reasons like a grade school dropout.

That's nolu spam/sham in a nutshell. Though maybe not so much "dropout" as "dropped on his head."

ConservingFreedom  posted on  2016-09-04   15:26:29 ET  Reply   Untrace   Trace   Private Reply  


#21. To: ConservingFreedom (#20)

Your pretended concern about medical marijuana is as believeable as the stories being spun by your heroine, Hillary.

As for getting approval of marijuana for medical use, the first major hurdle to get over is:

i. the drug’s chemistry must be known and reproducible

"The substance’s chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement."

See Fed. Reg. 81-156, 12 Aug 2016 at 53779.

I see how fast you have run from that. Of course, another hurdle will be the delivery system.

We do not ban drugs that have met all the requirements to be legally prescribed because a doctor misbehaves.

We do not authorize the dispensing of illegal drugs that have not met the requirements to be legally prescribed because you want to get high.

When you make an effort to create medical marijuana, you may be taken seriously. In the meantime, you might as well drop the bullshit and admit you are using the term medical marijuana just to further your cause of recreational marijuana. You want a legal high. Good luck with that.

nolu chan  posted on  2016-09-04   19:40:07 ET  Reply   Untrace   Trace   Private Reply  


#22. To: nolu chan (#21)

We do not ban drugs that have met all the requirements to be legally prescribed because a doctor misbehaves.

So the business about how some doctors misprescribe marijuana was a red herring on your part.

ConservingFreedom  posted on  2016-09-04   21:48:49 ET  Reply   Untrace   Trace   Private Reply  


#23. To: ConservingFreedom (#22)

So the business about how some doctors misprescribe marijuana was a red herring on your part.

No. It was pointing out that your crying about medicine for sick people is a crock of shit and always has been. All of a sudden, everybody has a debilitating condition that calls for marijuana which you apparently believe has been proven to cure all maladies known to man.

There is no such thing as misprescribing marijuana. It is illegal to possess, in any qualtity, pursuant to federal law. It is a crime in all 52 federal jurisdictions, which includes all 50 states.

It is your incessant bullshit about medical and medicine that is the red herring. Marijuana has never met the standards for a prescription drug product. Marijuana is not medicine.

You will do just about anything to change the subject from the requirements for medicine approval.

You can always try addressing the first element required by established case law. Or not. You can always just continue to act on your supreme belief that you can baffle people with your bullshit.

In general, a drug may have a ‘‘currently accepted medical use’’ in treatment in the United States if the drug meets a five-part test. Established case law (Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994)) upheld the Administrator of DEA’s application of the five-part test to determine whether a drug has a ‘‘currently accepted medical use.’’ The following describes the five elements that characterize ‘‘currently accepted medical use’’ for a drug:

i. the drug’s chemistry must be known and reproducible

‘‘The substance’s chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement.’’

81 FR 53779.

nolu chan  posted on  2016-09-05   0:24:24 ET  Reply   Untrace   Trace   Private Reply  


#24. To: nolu chan (#23)

All of a sudden, everybody has a debilitating condition that calls for marijuana which you apparently believe has been proven to cure all maladies known to man.

Beat those straw men.

ConservingFreedom  posted on  2016-09-05   0:25:49 ET  Reply   Untrace   Trace   Private Reply  


Replies to Comment # 24.

#25. To: ConservingFreedom (#24)

Beat those straw men.

You will do just about anything to change the subject from the requirements for medicine approval. Marijuana is illegal. It is not medicine.

You can always try addressing the first element required by established case law. Or not. You can always just continue to act on your supreme belief that you can baffle people with your bullshit.

In general, a drug may have a ‘‘currently accepted medical use’’ in treatment in the United States if the drug meets a five-part test. Established case law (Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994)) upheld the Administrator of DEA’s application of the five-part test to determine whether a drug has a ‘‘currently accepted medical use.’’ The following describes the five elements that characterize ‘‘currently accepted medical use’’ for a drug:

i. the drug’s chemistry must be known and reproducible

‘‘The substance’s chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement.’’

81 FR 53779.

That's one of five, and marijuana fails all five.

nolu chan  posted on  2016-09-05 01:23:48 ET  Reply   Untrace   Trace   Private Reply  


End Trace Mode for Comment # 24.

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