The US approval this week of a drug to treat Alzheimer's disease is being seen by some as crucial in the fight against a condition that affects more than 44 million worldwide.
After dozens of candidate drugs failed during clinical trials over the years, aducanumab could be the first therapy to actually slow the disease's progression, rather than just treat the symptoms.
But opinion is divided on whether the Food and Drug Administration was right to give the green light to a new Alzheimer's drug for the first time in two decades.
This specific drug is a small step forward. The fact there's been a drug approved I think is hugely significant
The FDA says there is "substantial evidence" the drug, marketed as Aduhelm, reduces beta amyloid plaques, which are aggregations of proteins that develop in the brains of many Alzheimer's patients.
This is despite a major international aducanumab trial involving thousands of patients having been cut short about two years ago because the drug appeared to be no better than the placebo it was compared to.
“For us clinical scientists, this [approval] has come as a bit of a surprise,” says Prof Paul Morgan, of the UK Dementia Research Institute at Cardiff University.
“The FDA has been persuaded because the drug is having an effect on the amyloid load in the brain, which seems to be clear, without any evidence it has an effect on cognition. They’ve tried to stretch the data to have a very small effect on a very small subset [of patients].”
Because of the burden that Alzheimer’s creates, and the lack of drug treatments, Prof Morgan says aducanumab has been “treated differently”.
“The need for something is huge, and because of that huge need, they’ve been pushed quite hard to approve something that in other circumstances wouldn’t have met the threshold for approval,” he says.
In this context, it is perhaps unsurprising that major organisations are split over the FDA’s decision.
The Alzheimer’s Association in the US says it “enthusiastically welcomes” the “historic” approval, but in a letter to the FDA, The American Geriatrics Society branded the decision “premature given the lack of sufficient evidence” aducanumab works.
The FDA's approval is conditional, in any case, on the success of confirmatory Phase 4 trials.
A desperate need for a treatment
Several drugs that have shown promise in experiments on mice have failed in clinical trials, something that has been all the more concerning given Alzheimer’s increasing prevalence in ageing societies.
Responsible for about two-thirds of cases of dementia and characterised by a loss of connection between the nerve cells or neurons that make up the brain, the disease causes memory loss, problems with speech and behavioural changes, as well as other effects.
Patients typically die within a decade of diagnosis, although the whole course of the disease lasts about a quarter of a century, including a lengthy period before symptoms emerge.
Aducanumab, an antibody treatment consisting of multiple identical proteins, attacks the beta amyloid plaques in patients' brains. In doing so, it may slow, but not stop, the progression of the disease.
While a major clinical trial seemed to show aducanumab was ineffective, reanalysis of results by the company behind the drug, the Massachusetts-based Biogen, appeared to indicate benefits at higher doses.
Not everyone is convinced. Among the critics of the FDA’s approval is Prof Rob Howard, professor of old age psychiatry at University College London, who says the stalled clinical trials “should really have been the end of it”.
He says data has been “cherry-picked” to demonstrate efficacy.
“Biogen have been so persistent and audacious in the way they continued to push,” he says. “The feeling of many of us is that you have to be led by the science. It’s a huge mistake to cave in to commercial pressure, and pressure from patient groups.”
Prof Howard says patients administered aducanumab are at risk of being exposed to “a placebo that has unpleasant side effects”, which include, in about one-third of those on high doses, a type of brain swelling that results in nausea and headaches.
In recent years, the FDA has reportedly rejected half a dozen other amyloid-based treatments, decisions that caused drug makers to scale back research into this field. With aducanumab’s approval, this may change.
“It’s going to distort the field in terms of what’s researched and trialled in the next five to 10 years,” says Prof Howard.
“In the meantime, other promising new treatments will be shut down because they will be considered too risky.”
A chance to slow the disease
Others, such as Prof Paul Matthews, head of the Department of Brain Sciences at Imperial College London, see the FDA’s decision as a positive.
The change in focus that may result from the approval will give “renewed confidence” amyloid is central to the cascade of damage caused to the brain by Alzheimer’s, Prof Matthews says.
"That will allow drug developers to target development around that concept in ways that likely will be able to move forward faster," he says.
While the effects in the Phase 3 trials were "modest or uncertain", he says the trials were short, and studies of the disease show that rapid, dramatic reversals should not in any case be expected.
"By getting [the drug] into the community, we will not only … help people, but we'll learn a great deal about it faster," he says.
“It’s a glass half-full and glass half-empty situation. This specific drug is a small step forward. The fact there’s been a drug approved I think is hugely significant.”
It has been suggested that the approval will, in addition, stimulate research into the use of multiple drugs to combat Alzheimer’s, an approach shown to be effective against, for example, cancer and HIV.
Not giving approval would, by contrast, have meant "another few years of no treatments", says Dr Liz Coulthard, an associate professor in dementia neurology at the University of Bristol in the UK.
Cautioning that aducanumab is “hardly a panacea”, Dr Coulthard, who points out that she was involved in one of the aducanumab trials and has undertaken work for Biogen, says it’s “a drug with a relatively small effect”.
Dr Coulthard would herself be willing to prescribe the drug to patients who fit the criteria, such as having early-stage disease.
“People with mild cognitive decline would still develop dementia,” she says. “But people will have more time, months or years, before progressing to full-blown dementia.”
She sees aducanumab being used as part of a multipronged approach that also includes lifestyle interventions to slow the progression of the disease.
European approval uncertain
Given the trial results, it is uncertain whether other regulatory agencies, such as the European Medicines Agency, will follow the FDA’s lead.
In some countries, such as the UK, aducanumab will have to additionally demonstrate it is value for money, which could be a significant hurdle given that the estimated annual cost of the intravenous infusions is $50,000.
Decisions are likely to be finely balanced, suggests Dr Ivan Koychev, a senior clinical researcher at the University of Oxford’s Department of Psychiatry and a consultant neuropsychiatrist.
“Normally you would say that whatever is approved by the FDA will get approval from Europe. In this case, because the data is so controversial, it’s a difficult one to call,” he says.
“Especially for the UK and other European countries, they will take a hard look at the cost-effectiveness of the drug.”
While aducanumab and the decision to approve it are controversial, the drug may offer reason for optimism after many years of frustration.
“It should give everyone who’s been affected by Alzheimer’s personally, or who has a relative or friend, hope that treatment is possible,” says Prof Matthews.
The specs
Engine: 5.0-litre supercharged V8
Transmission: Eight-speed auto
Power: 575bhp
Torque: 700Nm
Price: Dh554,000
On sale: now
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WHAT IS A BLACK HOLE?
1. Black holes are objects whose gravity is so strong not even light can escape their pull
2. They can be created when massive stars collapse under their own weight
3. Large black holes can also be formed when smaller ones collide and merge
4. The biggest black holes lurk at the centre of many galaxies, including our own
5. Astronomers believe that when the universe was very young, black holes affected how galaxies formed
Essentials
The flights
Emirates and Etihad fly direct from the UAE to Geneva from Dh2,845 return, including taxes. The flight takes 6 hours.
The package
Clinique La Prairie offers a variety of programmes. A six-night Master Detox costs from 14,900 Swiss francs (Dh57,655), including all food, accommodation and a set schedule of medical consultations and spa treatments.
Neil Thomson – THE BIO
Family: I am happily married to my wife Liz and we have two children together.
Favourite music: Rock music. I started at a young age due to my father’s influence. He played in an Indian rock band The Flintstones who were once asked by Apple Records to fly over to England to perform there.
Favourite book: I constantly find myself reading The Bible.
Favourite film: The Greatest Showman.
Favourite holiday destination: I love visiting Melbourne as I have family there and it’s a wonderful place. New York at Christmas is also magical.
Favourite food: I went to boarding school so I like any cuisine really.
The candidates
Dr Ayham Ammora, scientist and business executive
Ali Azeem, business leader
Tony Booth, professor of education
Lord Browne, former BP chief executive
Dr Mohamed El-Erian, economist
Professor Wyn Evans, astrophysicist
Dr Mark Mann, scientist
Gina MIller, anti-Brexit campaigner
Lord Smith, former Cabinet minister
Sandi Toksvig, broadcaster
Labour dispute
The insured employee may still file an ILOE claim even if a labour dispute is ongoing post termination, but the insurer may suspend or reject payment, until the courts resolve the dispute, especially if the reason for termination is contested. The outcome of the labour court proceedings can directly affect eligibility.
- Abdullah Ishnaneh, Partner, BSA Law
More from Neighbourhood Watch:
APPLE IPAD MINI (A17 PRO)
Display: 21cm Liquid Retina Display, 2266 x 1488, 326ppi, 500 nits
Chip: Apple A17 Pro, 6-core CPU, 5-core GPU, 16-core Neural Engine
Storage: 128/256/512GB
Main camera: 12MP wide, f/1.8, digital zoom up to 5x, Smart HDR 4
Front camera: 12MP ultra-wide, f/2.4, Smart HDR 4, full-HD @ 25/30/60fps
Biometrics: Touch ID, Face ID
Colours: Blue, purple, space grey, starlight
In the box: iPad mini, USB-C cable, 20W USB-C power adapter
Price: From Dh2,099
How does ToTok work?
The calling app is available to download on Google Play and Apple App Store
To successfully install ToTok, users are asked to enter their phone number and then create a nickname.
The app then gives users the option add their existing phone contacts, allowing them to immediately contact people also using the application by video or voice call or via message.
Users can also invite other contacts to download ToTok to allow them to make contact through the app.
Getting%20there%20and%20where%20to%20stay
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Six large-scale objects on show
- Concrete wall and windows from the now demolished Robin Hood Gardens housing estate in Poplar
- The 17th Century Agra Colonnade, from the bathhouse of the fort of Agra in India
- A stagecloth for The Ballet Russes that is 10m high – the largest Picasso in the world
- Frank Lloyd Wright’s 1930s Kaufmann Office
- A full-scale Frankfurt Kitchen designed by Margarete Schütte-Lihotzky, which transformed kitchen design in the 20th century
- Torrijos Palace dome
The British in India: Three Centuries of Ambition and Experience
by David Gilmour
Allen Lane
UAE currency: the story behind the money in your pockets
The specs
Engine: 2.0-litre 4-cylturbo
Transmission: seven-speed DSG automatic
Power: 242bhp
Torque: 370Nm
Price: Dh136,814
The National's picks
4.35pm: Tilal Al Khalediah
5.10pm: Continous
5.45pm: Raging Torrent
6.20pm: West Acre
7pm: Flood Zone
7.40pm: Straight No Chaser
8.15pm: Romantic Warrior
8.50pm: Calandogan
9.30pm: Forever Young
NO OTHER LAND
Director: Basel Adra, Yuval Abraham, Rachel Szor, Hamdan Ballal
Stars: Basel Adra, Yuval Abraham
Rating: 3.5/5
Killing of Qassem Suleimani
Credits
Produced by: Colour Yellow Productions and Eros Now
Director: Mudassar Aziz
Cast: Sonakshi Sinha, Jimmy Sheirgill, Jassi Gill, Piyush Mishra, Diana Penty, Aparshakti Khurrana
Star rating: 2.5/5
Company%20profile
%3Cp%3E%3Cstrong%3EName%3A%3C%2Fstrong%3E%20WallyGPT%3Cbr%3E%3Cstrong%3EStarted%3A%20%3C%2Fstrong%3E2014%3Cbr%3E%3Cstrong%3EFounders%3A%20%3C%2Fstrong%3ESaeid%20and%20Sami%20Hejazi%3Cbr%3E%3Cstrong%3EBased%3A%3C%2Fstrong%3E%20Dubai%3Cbr%3E%3Cstrong%3ESector%3A%20%3C%2Fstrong%3EFinTech%3Cbr%3E%3Cstrong%3EInvestment%20raised%3A%20%3C%2Fstrong%3E%247.1%20million%3Cbr%3E%3Cstrong%3ENumber%20of%20staff%3A%3C%2Fstrong%3E%2020%3Cbr%3E%3Cstrong%3EInvestment%20stage%3A%20%3C%2Fstrong%3EPre-seed%20round%3C%2Fp%3E%0A
Conflict, drought, famine
Estimates of the number of deaths caused by the famine range from 400,000 to 1 million, according to a document prepared for the UK House of Lords in 2024.
It has been claimed that the policies of the Ethiopian government, which took control after deposing Emperor Haile Selassie in a military-led revolution in 1974, contributed to the scale of the famine.
Dr Miriam Bradley, senior lecturer in humanitarian studies at the University of Manchester, has argued that, by the early 1980s, “several government policies combined to cause, rather than prevent, a famine which lasted from 1983 to 1985. Mengistu’s government imposed Stalinist-model agricultural policies involving forced collectivisation and villagisation [relocation of communities into planned villages].
The West became aware of the catastrophe through a series of BBC News reports by journalist Michael Buerk in October 1984 describing a “biblical famine” and containing graphic images of thousands of people, including children, facing starvation.
Band Aid
Bob Geldof, singer with the Irish rock group The Boomtown Rats, formed Band Aid in response to the horrific images shown in the news broadcasts.
With Midge Ure of the band Ultravox, he wrote the hit charity single Do They Know it’s Christmas in December 1984, featuring a string of high-profile musicians.
Following the single’s success, the idea to stage a rock concert evolved.
Live Aid was a series of simultaneous concerts that took place at Wembley Stadium in London, John F Kennedy Stadium in Philadelphia, the US, and at various other venues across the world.
The combined event was broadcast to an estimated worldwide audience of 1.5 billion.
Results
Male 51kg Round 1
Dias Karmanov (KAZ) beat Mabrook Rasea (YEM) by points 2-1.
Male 54kg Round 1
Yelaman Sayassatov (KAZ) beat Chen Huang (TPE) TKO Round 1; Huynh Hoang Phi (VIE) beat Fahad Anakkayi (IND) RSC Round 2; Qais Al Jamal (JOR) beat Man Long Ng (MAC) by points 3-0; Ayad Albadr (IRQ) beat Yashar Yazdani (IRI) by points 2-1.
Male 57kg Round 1
Natthawat Suzikong (THA) beat Abdallah Ondash (LBN) by points 3-0; Almaz Sarsembekov (KAZ) beat Ahmed Al Jubainawi (IRQ) by points 2-1; Hamed Almatari (YEM) beat Nasser Al Rugheeb (KUW) by points 3-0; Zakaria El Jamari (UAE) beat Yu Xi Chen (TPE) by points 3-0.
Men 86kg Round 1
Ahmad Bahman (UAE) beat Mohammad Al Khatib (PAL) by points 2-1
Men 63.5kg Round 1
Noureddin Samir (UAE) beat Polash Chakma (BAN) RSC Round 1.
Female 45kg quarter finals
Narges Mohammadpour (IRI) beat Yuen Wai Chan (HKG) by points.
Female 48kg quarter finals
Szi Ki Wong (HKG) beat Dimple Vaishnav (IND) RSC round 2; Thanawan Thongduang (THA) beat Nastaran Soori (IRI) by points; Shabnam Hussain Zada (AFG) beat Tzu Ching Lin (TPE) by points.
Female 57kg quarter finals
Nguyen Thi Nguyet (VIE) beat Anisha Shetty (IND) by points 2-1; Areeya Sahot (THA) beat Dana Al Mayyal (KUW) RSC Round 1; Sara Idriss (LBN) beat Ching Yee Tsang (HKG) by points 3-0.
THE SPECS
Engine: 3.5-litre supercharged V6
Power: 416hp at 7,000rpm
Torque: 410Nm at 3,500rpm
Transmission: 6-speed manual
Fuel consumption: 10.2 l/100km
Price: Dh375,000
On sale: now
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%3Cp%3E%3Cstrong%3EName%3A%20%3C%2Fstrong%3EMaly%20Tech%3Cbr%3E%3Cstrong%3EStarted%3A%3C%2Fstrong%3E%202023%3Cbr%3E%3Cstrong%3EFounder%3A%3C%2Fstrong%3E%20Mo%20Ibrahim%3Cbr%3E%3Cstrong%3EBased%3A%3C%2Fstrong%3E%20Dubai%20International%20Financial%20Centre%3Cbr%3E%3Cstrong%3ESector%3A%3C%2Fstrong%3E%20FinTech%3Cbr%3E%3Cstrong%3EFunds%20raised%3A%3C%2Fstrong%3E%20%241.6%20million%3Cbr%3E%3Cstrong%3ECurrent%20number%20of%20staff%3A%3C%2Fstrong%3E%2015%3Cbr%3E%3Cstrong%3EInvestment%20stage%3A%20%3C%2Fstrong%3EPre-seed%2C%20planning%20first%20seed%20round%3Cbr%3E%3Cstrong%3EInvestors%3A%3C%2Fstrong%3E%20GCC-based%20angel%20investors%3C%2Fp%3E%0A
ABU%20DHABI'S%20KEY%20TOURISM%20GOALS%3A%20BY%20THE%20NUMBERS
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The Birkin bag is made by Hermès.
It is named after actress and singer Jane Birkin
Noone from Hermès will go on record to say how much a new Birkin costs, how long one would have to wait to get one, and how many bags are actually made each year.
Babumoshai Bandookbaaz
Director: Kushan Nandy
Starring: Nawazuddin Siddiqui, Bidita Bag, Jatin Goswami
Three stars
more from Janine di Giovanni
Company%20Profile
%3Cp%3E%3Cstrong%3ECompany%20name%3A%3C%2Fstrong%3E%20myZoi%3Cbr%3E%3Cstrong%3EStarted%3A%3C%2Fstrong%3E%202021%3Cbr%3E%3Cstrong%3EFounders%3A%3C%2Fstrong%3E%20Syed%20Ali%2C%20Christian%20Buchholz%2C%20Shanawaz%20Rouf%2C%20Arsalan%20Siddiqui%2C%20Nabid%20Hassan%3Cbr%3E%3Cstrong%3EBased%3A%3C%2Fstrong%3E%20UAE%3Cbr%3E%3Cstrong%3ENumber%20of%20staff%3A%3C%2Fstrong%3E%2037%3Cbr%3E%3Cstrong%3EInvestment%3A%3C%2Fstrong%3E%20Initial%20undisclosed%20funding%20from%20SC%20Ventures%3B%20second%20round%20of%20funding%20totalling%20%2414%20million%20from%20a%20consortium%20of%20SBI%2C%20a%20Japanese%20VC%20firm%2C%20and%20SC%20Venture%3C%2Fp%3E%0A
Call of Duty: Black Ops 6
Developer: Treyarch, Raven Software
Publisher: Activision
Console: PlayStation 4 & 5, Windows, Xbox One & Series X/S
Rating: 3.5/5
MATCH INFO
Uefa Champions League last-16, second leg:
Real Madrid 1 (Asensio 70'), Ajax 4 (Ziyech 7', Neres 18', Tadic 62', Schone 72')
Ajax win 5-3 on aggregate
The specs
Engine: 4.0-litre V8 twin-turbocharged and three electric motors
Power: Combined output 920hp
Torque: 730Nm at 4,000-7,000rpm
Transmission: 8-speed dual-clutch automatic
Fuel consumption: 11.2L/100km
On sale: Now, deliveries expected later in 2025
Price: expected to start at Dh1,432,000
Citizenship-by-investment programmes
United Kingdom
The UK offers three programmes for residency. The UK Overseas Business Representative Visa lets you open an overseas branch office of your existing company in the country at no extra investment. For the UK Tier 1 Innovator Visa, you are required to invest £50,000 (Dh238,000) into a business. You can also get a UK Tier 1 Investor Visa if you invest £2 million, £5m or £10m (the higher the investment, the sooner you obtain your permanent residency).
All UK residency visas get approved in 90 to 120 days and are valid for 3 years. After 3 years, the applicant can apply for extension of another 2 years. Once they have lived in the UK for a minimum of 6 months every year, they are eligible to apply for permanent residency (called Indefinite Leave to Remain). After one year of ILR, the applicant can apply for UK passport.
The Caribbean
Depending on the country, the investment amount starts from $100,000 (Dh367,250) and can go up to $400,000 in real estate. From the date of purchase, it will take between four to five months to receive a passport.
Portugal
The investment amount ranges from €350,000 to €500,000 (Dh1.5m to Dh2.16m) in real estate. From the date of purchase, it will take a maximum of six months to receive a Golden Visa. Applicants can apply for permanent residency after five years and Portuguese citizenship after six years.
“Among European countries with residency programmes, Portugal has been the most popular because it offers the most cost-effective programme to eventually acquire citizenship of the European Union without ever residing in Portugal,” states Veronica Cotdemiey of Citizenship Invest.
Greece
The real estate investment threshold to acquire residency for Greece is €250,000, making it the cheapest real estate residency visa scheme in Europe. You can apply for residency in four months and citizenship after seven years.
Spain
The real estate investment threshold to acquire residency for Spain is €500,000. You can apply for permanent residency after five years and citizenship after 10 years. It is not necessary to live in Spain to retain and renew the residency visa permit.
Cyprus
Cyprus offers the quickest route to citizenship of a European country in only six months. An investment of €2m in real estate is required, making it the highest priced programme in Europe.
Malta
The Malta citizenship by investment programme is lengthy and investors are required to contribute sums as donations to the Maltese government. The applicant must either contribute at least €650,000 to the National Development & Social Fund. Spouses and children are required to contribute €25,000; unmarried children between 18 and 25 and dependent parents must contribute €50,000 each.
The second step is to make an investment in property of at least €350,000 or enter a property rental contract for at least €16,000 per annum for five years. The third step is to invest at least €150,000 in bonds or shares approved by the Maltese government to be kept for at least five years.
Candidates must commit to a minimum physical presence in Malta before citizenship is granted. While you get residency in two months, you can apply for citizenship after a year.
Egypt
A one-year residency permit can be bought if you purchase property in Egypt worth $100,000. A three-year residency is available for those who invest $200,000 in property, and five years for those who purchase property worth $400,000.
Source: Citizenship Invest and Aqua Properties
