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Thursday, September 01, 2016

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New Alzheimer’s drug clears abnormal protein clogs in small, promising trial

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BY KAREN WEINTRAUB, Scientific American
Amyloid plaques, a key feature of Alzheimer's disease, were reduced significantly by a year of treatment with a new drug called aducanumab. Photo by Sevigny et al., Nature, 2016

Amyloid plaques, a key feature of Alzheimer’s disease, were reduced significantly
by a year of treatment with a new drug called aducanumab. Photo by Sevigny et al., Nature, 2016
A new drug trial that some researchers are calling the most promising yet in the fight against Alzheimer’s suggests it may be possible to clear the brain of the amyloid protein that is characteristic of the disease.

The results are very impressive and very encouraging.
The study was small and researchers caution that it’s far too soon to declare victory against a fatal disease that robs people of their memories and ability to function in daily life. But despite repeated failures of Alzheimer’s drugs in the past, there was room for enthusiasm about the trial, the results of which were published today in Nature.

“This is the best news we’ve had in my 25 years of doing Alzheimer’s research,” says Stephen Salloway, a professor of clinical neurosciences and psychiatry at Brown University and a co-author of the paper.

The longer an early-stage Alzheimer’s patient took the drug aducanumab, and the higher the dose, the less clogged their brain was with amyloid a year later. The 21 subjects who made it through the study on the highest dose had no detectable amyloid deposits left in their brains after a year.

“The effect size of this drug is unprecedented,” says paper co-author Roger Nitsch, president and founder of Zurich-based Neurimmune, which initially developed aducanumab.

The drug also increased the risk of stroke and potentially dangerous fluid shifts in the brain, however, forcing a balancing act between its effectiveness and patients’ ability to tolerate a high-enough dose. Researchers were able to catch early signs of the side effect, known as amyloid-related imaging abnormalities (ARIA), through MRI brain scans, Salloway says, and no one in the trial suffered irreversible harm.

Aducanumab is an antibody, a natural substance the body produces to fight disease.
The trial was too small to show whether the reduction in brain amyloid made a difference in the everyday functioning of the participants, although there were some indications the drug slowed cognitive and functional decline in those who received the highest dose for more than six months. Most of the trial results have been released previously at public meetings. The new publication offers more depth and marks the first time the results have been peer-reviewed and presented comprehensively, the authors said in an August 30 news conference.

The small trial showed promise, but the real test of aducanumab is underway in two much larger studies funded in collaboration with the drug company Biogen, which has partnered with Neurimmune to bring aducanumab to market. Those trials, begun last year, will include 2,700 participants in North America, Europe and Japan, who will take the drug for 18 months. If the trials are successful, the companies will go on to apply to the U.S. Food and Drug Administration for permission to sell aducanumab to patients.


Aducanumab, a new drug, caused a dose-dependent reduction in amyloid plaques, a key feature of Alzheimer's disease. Photo by Sevigny et al., Nature, 2016

Aducanumab, a new drug, caused a dose-dependent reduction in amyloid plaques, a key feature of Alzheimer’s disease. Photo by Sevigny et al., Nature, 2016

Salloway and others said they do not expect aducanumab, even if it works well, to be “the” solution to Alzheimer’s. As with other complex diseases like cancer and HIV, a cocktail or series of drugs will likely be necessary. The drug will also likely be most useful at the disease’s earliest stages, when removing amyloid can hopefully make a difference in Alzheimer’s trajectory, said Biogen Group Senior Vice President Alfred Sandrock, who led the research and press conference.

Aducanumab is an antibody, a natural substance the body produces to fight disease. The compound was derived from healthy older people who had not developed Alzheimer’s, under the presumption that they carried some kind of protective factors in their immune systems. It is still not completely clear how aducanumab works, although the study shows it targets amyloid in the brain but not in the bloodstream.

The hypothesis suggests antibodies that attack amyloid in the bloodstream get sidetracked and never make it into the brain. By focusing on brain amyloid, aducanumab seems to be able to cross into the brain to reach its target, researchers said at the press conference.

In the two larger studies participants will start on a lower dose to minimize their risk of ARIA, which is more likely to occur early in treatment, and people who carry at least one copy of the APOE ε4Alzheimer’s risk gene, who are more vulnerable to ARIA, will probably remain on a lower dose, according to Salloway.

If the drug performs well in the larger trials…it could be used in people in their 40s and 50s who are starting to show the first evidence of amyloid buildup.
Participants must have evidence of excessive amounts of amyloid in their brains, as shown in a PET scan, before being allowed into the study. This should help avoid a problem that may have doomed earlier drug trials. Those trials failed in part, researchers think, because they included too many people without excessive amyloid in their brains and must therefore have had a form of dementia other than Alzheimer’s. Earlier trials are also believed to have failed because they tested patients whose disease was too advanced and the damage irrevocable. In contrast, aducanumab is being tested in patients with only very early evidence of disease.

Others in the Alzheimer’s field expressed enthusiasm this week for the paper and the ongoing study of aducanumab.

“The results are very impressive and very encouraging,” says Rudolph Tanzi, a neurologist at Harvard University and a longtime leader in Alzheimer’s research. “The fact is [the authors are] the first ones to show some level of proof that an anti-amyloid therapy is a way to treat or prevent Alzheimer’s.”

If the drug performs well in the larger trials, Tanzi says he expects it could be used in people in their 40s and 50s who are starting to show the first evidence of amyloid buildup. Clearing out amyloid then and keeping levels low with another type of drug that Tanzi is working to develop might prevent them from ever having Alzheimer’s, he says.

James Hendrix, director of global science initiatives for the Alzheimer’s Association, also praised the trial, saying he was impressed with its design as well as its results. He said the study also shows how crucial it is for people to volunteer for Alzheimer’s research studies, to help better understand the disease and how to treat it. Because of the stigma surrounding Alzheimer’s, researchers typically struggle to find enough volunteers to fill studies, he says, adding that the Alzheimer’s Association offers information on ongoing trials on its Web site.

This article is reproduced with permission from Scientific American. It was first published on August 31, 2016. Find the original story here.

Attorney Morton “Mordy” Avigdor, the politically connected Orthodox Jewish frontrunner candidate for the Fifth Municipal Judicial Civil Court seat, could face sanctions and possible disbarment for failing to make full and accurate disclosures on his Ethics Commission Financial Disclosure form filed as part of his application to run for the bench seat, according to court documents filed this week.




Judiciary Elections

Politically Connected Judicial Candidate Faces Possible Disbarment, Court Papers Allege


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Judicial Candidate Morton "Mordy" Avigdor



Attorney Morton “Mordy” Avigdor, the politically connected Orthodox Jewish frontrunner candidate for the Fifth Municipal Judicial Civil Court seat, could face sanctions and possible disbarment for failing to make full and accurate disclosures on his Ethics Commission Financial  Disclosure form filed as part of his application to run for the bench seat, according to court documents filed this week.

The litigation has roots in a 2004 Surrogate Court Case, in which Avigdor was named  co executor and trustee of the late Elias Gelbwachs’ estate.

According to court papers, Avigdor took money from the estate and bought property at 7104 Ft. Hamilton Parkway and 884 71st Street in Brooklyn. Ultimately, the court ordered Avigdor to liquidate the properties and pay the estate $750,000. However, Avigdor allegedly took some of the estate money and bought other properties with it.

After paying back only a fraction of the money and still owing $500,000 to the estate, the court suspended Avigdor as executor and trustee of the estate on July 30, 2010.

Then, in 2014, Avigdor filed suit against Dr. Paul Rosenstock, alleging he was owed current and future money as part owner of Rosenstock’s medical company, Doctors On Call (DOC), after investing $35,000 in 2005. Additionally, court documents indicate that Rosenstock ran his business for some time out of the Ft. Hamilton property that Avigdor bought with Gelbwach’s Estate money.
But Rosenstock’s attorney, Israel Goldberg, filed a summary motion on Monday to dismiss the case on the grounds that if Avigdor is part owner in the business as he alleges, then he would have listed it as a business asset in his financial disclosure report submitted to the Ethics Commission of the State Unified Court System as part of the application process to run for judge.

“Indeed, if Avigdor did hold a position or an investment interest in DOC or a beneficial interest in any of the Defendants named in this action but he failed to report it on the Financial Disclosure form, he would be subject to disbarment,” wrote Goldberg in the summary motion.

In the motion, Goldberg also cited a case where a former Justice of the Supreme Court who intentionally withheld information about a loan on his mandatory financial disclosure statement was disbarred because case law indicates an individual required to file financial disclosure is required to file accurate, truthful disclosure. Further, one ‘who knowingly and willfully with intent to deceive makes a false statement or gives information which such individual knows to be false … shall be subject to disciplinary action.’”

The motion was calendared in to be heard before Judge Sylvia Ash for mid-September, after the Sept. 13 judicial primary.

Both Avigdor and Goldberg refused comment on pending litigation.

The litigation comes as Avigdor, who has worked with former Congressman Anthony Weiner and current Congresswoman Yvette Clarke, as well with several large local nonprofit organizations, is locked in a three-way race for the bench seat.

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Rachel “Ruchie” Freier

His chief rival in the race is Attorney Rachel “Ruchie” Freier, also a devout Orthodox Jew, who has garnered respect and controversy in the tight-knit Boro Park community for both helping at-risk Orthodox Jewish boys and creating the all-women volunteer Ezras Nashim ambulance company.

Rounding up the judicial judge race is attorney and secular Jew, Jill Epstein, but the bench seat has traditionally gone to whomever carries Borough Park, likely a religious Jew. However, should Avigdor and Freier split the religious vote, Epstein could squeak through.

The judicial district also includes Sunset Park, South Slope, Windsor Terrace, Kensington, Green-Wood and several neighborhoods to the south.

http://www.kingscountypolitics.com/politically-connected-judicial-candidate-faces-possible-disbarment-court-paper-allege/