CHICAGO: The first big breakthrough in 30 years of Alzheimer’s research is providing momentum for clinical trials of “cocktail” treatments targeting the two hallmark proteins associated with the mind-robbing disease, according to interviews with researchers and pharmaceutical executives.
Drugmakers Eisai Co Ltd and Biogen reported in September that their therapy lecanemab could slow progress of the disease by 27% over 18 months compared with a placebo
The finding validates the theory that clearing the amyloid protein that forms clumps in the brains of Alzheimer’s patients could slow or halt the disease and has strengthened the support from some scientists for simultaneously targeting another notorious protein linked to Alzheimer's: tau.
Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer's Disease conference in San Francisco. The U.S. Food and Drug Administration is expected to make a decision by early January on the companies’ application for accelerated approval.
If approved on an accelerated basis, the companies said they would immediately apply for full U.S. regulatory approval which could help secure Medicare coverage. To date, two deaths have been reported among patients who received lecanemab in conjunction with medicine to prevent or clear blood clots, though industry analysts do not expect those developments alone to prevent approval.
"I think lecanemab has reinvigorated the idea that now you could do a combination of amyloid (and) tau,” Dr. Reisa Sperling, a neurologist and Alzheimer’s researcher at Harvard Medical School, said in an interview.
Tau naturally accumulates in a memory center of the brain called the medial temporal lobe as people age. A growing body of research suggests that rising levels of amyloid in Alzheimer’s patients act as an accelerant, causing an explosive spread of tau that forms toxic tangles inside brain cells, eventually killing them.
“We've been trying to do combination trials for years,” Sperling said. Nearly a decade ago, Alzheimer’s experts met in Washington to discuss testing combined therapies. At the time, “no one would listen,” she said.
Now, however, Sperling and other researchers in the Alzheimer's Clinical Trials Consortium (ACTC), a research network backed by the National Institute on Aging (NIA), say drugmakers are increasingly interested in participating in a study to test tau drugs alone and in combination with anti-amyloid drugs such as lecanemab.
“We've been talking to multiple companies about working with us on our proposed platform, which can evaluate multiple drugs, and everybody's interested,” said Dr. Paul Aisen, director of the Alzheimer’s Therapeutic Research Institute at the University of Southern California’s Keck School of Medicine, and a leader with Sperling of the ACTC.
The scientists said they expect an answer on funding by year-end. The U.S. National Institutes of Health, which oversees NIA, said it does not discuss grants under review.
BILLIONS SPENT
More than 6 million Americans have Alzheimer’s, costing the U.S. economy nearly $6 billion a year in direct spending and unpaid caregiving expenses, according to congressional briefing documents. By 2050, Alzheimer’s cases are expected to double to 12.7 million, bringing the total yearly cost to nearly $1 trillion, according to the documents.
Last year, the FDA gave Biogen and Eisai’s drug aducanumab conditional approval even though it failed one of its two late-stage trials. The approval was based on the drug’s ability to remove amyloid from the brain.
Biogen initially priced the drug at $56,000 a year, but the U.S. Centers for Medicare and Medicaid Services said it needed more compelling evidence, and that Medicare would only cover the drug for use in clinical trials.
Lecanemab’s success rests on years of research into the causes of Alzheimer’s as well as advances in measuring amyloid deposits through brain scans and spinal fluids. Trials of tau drugs will aim to build on that progress, using brain scans, spinal fluids and blood tests to better assess the stage of disease, when to intervene and whether the drug is hitting its target. That would allow companies to test drugs even before symptoms emerge.
Nearly a dozen drugmakers, including Roche, Merck & Co, Johnson & Johnson and Eli Lilly and are working on therapies that target tau. At least 16 treatments are being tested in clinical trials, with results expected over the next three years, according to a Reuters review of the clinicaltrials.gov registry.
Merck is testing its MK-2214 therapy aimed at clearing tau in patients in very early stages of the disease in several small trials.
"The understanding of the disease is getting much, much better," said Jason Uslaner, Merck’s head of discovery neuroscience. The drugmaker has been largely absent from the Alzheimer's space after the high-profile failure of its drug verubecestat five years ago.
So far, only a few trials combine an amyloid-lowering therapy with a drug that targets tau in a “cocktail” approach, similar to those used against cancers and HIV.
Such combinations may improve on the benefit of lowering amyloid alone in people who have symptoms, researchers told Reuters. And when used earlier in the disease, the hope is that they might prevent dementia altogether.
“It may be that you need both - the removal of amyloid that's driving that biological cascade - and you need to clean up any tau that's already spreading from one cell to another,” said Dr. Adam Boxer, a tau expert at the University of California San Francisco (UCSF) Memory and Aging Center.
But several antibody therapies from Lilly, Biogen and AbbVie that were designed to slow the rate of tau accumulations failed outright last year. A drug from Roche, semorinemab, showed limited effectiveness.
"It took maybe 20 or 30 years before we found a drug that really targeted the right form of amyloid to make a difference,” Boxer said. “It’s still early days.”
Reuters
Wed Nov 30 2022
![Rare success for Alzheimer's research unlocks hope for future therapies Rare success for Alzheimer's research unlocks hope for future therapies](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2020-09/41600679419_AlzheimerDemensia.jpg)
Drugmakers Eisai Co Ltd and Biogen reported in September that their therapy lecanemab could slow progress of the disease by 27% over 18 months compared with a placebo. - BERNAMA/Filepic
AWANI Borneo [16/07/2024] – SUKMA 2024 | Sentiasa berwaspada | Pintu sempadan
AWANI Borneo Selasa, 16 Julai 2024 bersama Fauzi Zin.
- SUKMA 2024 : Nasib acara takraw wanita diketahui Khamis ini.
- Ribut petir diramal di Sabah, Bomba saran penduduk berhati-hati.
- Urusan imigresen di sempadan, Malaysia-Brunei adakan rundingan.
- SUKMA 2024 : Nasib acara takraw wanita diketahui Khamis ini.
- Ribut petir diramal di Sabah, Bomba saran penduduk berhati-hati.
- Urusan imigresen di sempadan, Malaysia-Brunei adakan rundingan.
![Hukuman penjara bapa lakukan serangan seksual ke atas 3 anak perempuan dikurangkan Hukuman penjara bapa lakukan serangan seksual ke atas 3 anak perempuan dikurangkan](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-04/51714453013_courtgavelmahkam.jpg)
Hukuman penjara bapa lakukan serangan seksual ke atas 3 anak perempuan dikurangkan
Dalam penghakimannya, Che Mohd Ruzima berkata perayu gagal membuktikan bahawa Mahkamah Sesyen terkhilaf dalam memutuskan kes itu.
Malaysia-Brunei adakan rundingan mudahkan urusan Imigresen
Malaysia dan Brunei akan mengadakan rundingan bagi memudahkan proses keluar masuk rakyat kedua-dua negara.
![Pan-gon mahu kekal hubungan baik dengan Malaysia Pan-gon mahu kekal hubungan baik dengan Malaysia](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-07/81721124936_KimPanGon.jpg)
Pan-gon mahu kekal hubungan baik dengan Malaysia
Bekas ketua jurulatih Harimau Malaya Kim Pan-gon mahu mengekalkan hubungan baik dengan skuad itu biarpun tidak lagi bersama.
Kos pampasan tanah fasa 1B proses Projek LPB Sabah RM1.2 bilion - Alexander
Anggaran kos pengambilan balik tanah bagi keseluruhan Fasa 1B proses pengambilan tanah dan penilaian pampasan tanah bagi Projek Lebuh Raya Pan Borneo Sabah (LPB Sabah) berjumlah RM1.2 bilion.
Sentiasa berhati-hati, ribut petir diramal berlaku di Sabah
Orang ramai khususnya yang tinggal di kawasan berisiko di Sabah disaran agar bersiap siaga terutama dari segi perubahan cuaca yang tidak menentu yang seterusnya akan mengakibatkan bencana banjir dan pokok tumbang.
Nasib acara sepak takraw wanita diketahui Khamis ini
Nasib acara sepak takraw wanita berpasukan dalam Sukan Malaysia (SUKMA) edisi ke-21 di Sarawak akan ditentukan dalam Mesyuarat Jawatankuasa SUKMA Peringkat Kebangsaan pada Khamis ini.
JPBM Sabah serah jentera khas buat pasukan sukarela
Jabatan Bomba dan Penyelamat Malaysia (JBPM) negeri Sabah sedang dalam perancangan untuk menyerahkan jentera khas, iaitu Volunter Fire Rescue Tender (VFRT) untuk Pasukan Bomba Sukarela (PBS) di Sabah.
Sarawak akan pertahan pingat sukan Muay Thai edisi lalu
Skuad Sarawak akan berusaha mempertahankan masing-masing dua emas, perak dan gangsa dalam kejohanan SUKMA yang dimenangi dalam edisi lalu.
![Usaha pujuk Pan-gon tidak berhasil - Yusoff Mahadi Usaha pujuk Pan-gon tidak berhasil - Yusoff Mahadi](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2024-07/81721124841_TBFAM.jpg)
Usaha pujuk Pan-gon tidak berhasil - Yusoff Mahadi
FAM pernah berusaha memujuk Kim Pan-gon untuk terus mengemudi skuad Harimau Malaya hingga kontraknya tamat secara rasmi pada akhir tahun depan.
![Berita antarabangsa pilihan sepanjang hari ini Berita antarabangsa pilihan sepanjang hari ini](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2023-04/41680607592_TBBERITAx.jpg)
Berita antarabangsa pilihan sepanjang hari ini
Antara pelbagai berita luar negara yang disiarkan di Astro AWANI, berikut adalah antara yang paling menjadi tumpuan sepanjang hari ini.
![Tony Bennett meninggal dunia pada usia 96 tahun Tony Bennett meninggal dunia pada usia 96 tahun](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2023-07/71689947195_TBTONYBENNET.jpg)
Tony Bennett meninggal dunia pada usia 96 tahun
Penyanyi pop dan jazz popular yang memenangi 20 Anugerah Grammy, Tony Bennett meninggal dunia pada usia 96 tahun di New York, pada Jumaat.
![FDA AS lulus ubat Leqembi untuk rawat Alzheimer FDA AS lulus ubat Leqembi untuk rawat Alzheimer](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2023-07/41688790542_LEQEMBIAlzheimer.jpg)
FDA AS lulus ubat Leqembi untuk rawat Alzheimer
Leqembi berfungsi dengan mengurangkan amyloid plaques yang terbentuk di dalam otak, menurut FDA.
![Pesakit Alzheimer di seluruh dunia mungkin cecah 139 juta menjelang 2050 - Laporan Pesakit Alzheimer di seluruh dunia mungkin cecah 139 juta menjelang 2050 - Laporan](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2021-06/71623120622_ALZHEIMERS.jpg)
Pesakit Alzheimer di seluruh dunia mungkin cecah 139 juta menjelang 2050 - Laporan
Jumlah pesakit Alzheimer di dunia mungkin mencecah 139 juta menjelang 2050, menurut laporan terbaharu Pertubuhan Kesihatan Sedunia (WHO).
![Isteri hidap Alzheimer turut dijangkiti COVID-19, Engelbert Humperdinck mohon doa peminat Isteri hidap Alzheimer turut dijangkiti COVID-19, Engelbert Humperdinck mohon doa peminat](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2021-02/61612529082_EngelbertHumperdinc.jpg)
Isteri hidap Alzheimer turut dijangkiti COVID-19, Engelbert Humperdinck mohon doa peminat
Penyanyi balada terkenal Britain, Engelbert Humperdinck meminta peminat agar mendoakan kesihatan isterinya.
![Hari Alzheimer Sedunia: KKM bangunkan Pelan Tindakan Demensia 2021-2030 Hari Alzheimer Sedunia: KKM bangunkan Pelan Tindakan Demensia 2021-2030](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2020-09/41600679419_AlzheimerDemensia.jpg)
Hari Alzheimer Sedunia: KKM bangunkan Pelan Tindakan Demensia 2021-2030
Ketika ini KKM mengambil beberapa inisiatif dalam meningkatkan liputan rawatan dalam penjagaan geriatrik.
![Pesakit Alzheimer perlu penjagaan rapi Pesakit Alzheimer perlu penjagaan rapi](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2020-09/51600662334_AlzheimerDemensia.jpg)
Pesakit Alzheimer perlu penjagaan rapi
Dengan peningkatan populasi warga emas, sistem sokongan dalam masyarakat perlu dipertingkatkan bagi membantu ahli keluarga yang menjaga warga emas yang menghidap Alzheimer.
![Penghidap Alzheimer makin bertambah, Malaysia masih tiada Pelan Demensia Kebangsaan Penghidap Alzheimer makin bertambah, Malaysia masih tiada Pelan Demensia Kebangsaan](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/https://img.astroawani.com/2020-09/71600663318_AlzheimerDementia.jpg)
Penghidap Alzheimer makin bertambah, Malaysia masih tiada Pelan Demensia Kebangsaan
Pelan Demensia Kebangsaan itu akan membantu 'generasi sandwich' iaitu golongan pertengahan usia yang mempunyai komitmen bukan sahaja membesarkan anak-anak tetapi juga menjaga ibu bapa mereka.
!['Kawanku', peranti bantu warga emas nyanyuk 'Kawanku', peranti bantu warga emas nyanyuk](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/http://img.astroawani.com/2018-12/71544252467_TBPROTOTAIPx.jpg)
'Kawanku', peranti bantu warga emas nyanyuk
'Kawanku' berpotensi membantu warga emas menjalani aktiviti harian melalui maklumat dan arahan audio secara automatik.
![Akibat ketagih, 'Pakcik Pokemon' luang 20 jam bawa 11 telefon keliling Taipei Akibat ketagih, 'Pakcik Pokemon' luang 20 jam bawa 11 telefon keliling Taipei](https://resizer-awani.eco.astro.com.my/tr:w-177,h-100,q-100,f-auto/http://img.astroawani.com/2018-08/51533962910_TBPokemon.jpg)
Akibat ketagih, 'Pakcik Pokemon' luang 20 jam bawa 11 telefon keliling Taipei
Chen San-yuan, 70, mampu bermain Pokemon Go sehingga 20 jam tanpa henti menggunakan 11 telefon dan sembilan power bank yang dibawanya.