This is FRM's third Alzheimer newsletter. You will find there a return on the novelties of 2020 then the program of the world advances planned for 2021 in the fight against Alzheimer's disease.
Good reading !
What were the novelties concerning Alzheimer's disease in 2020 within the FRM network?
In 2020, eight articles related to Alzheimer's disease and citing FRM support were published. Four of them are linked to the 3C cohort study, also called the Three Cities study. Started in 1999, this study includes nearly 10,000 people. This year's publications identify new risk factors such as positive HSV-1 IgM levels in ApoE4+ patients, atrophy of the hippocampus and specifically Ammon's horn as well as regular consumption of sweet snacks in ApoE4+ patients.
In addition, last November, the 2020 Medical Research Foundation Awards were held. Twenty researchers and journalists were rewarded on this occasion. Regarding research against Alzheimer's disease, Professor Luc Buée received the Bernadette and Pierre Duban prize. Congratulations !
What can we expect from 2021?
This infographic presents the main results expected for the end of this year and the year 2021 as well as an estimate of their publication date. In order to remain concise, we have selected information related to phase 3 clinical trials only.
- Results expected from the phase 2b/3 clinical trial of masitinib (AB Science)
This tyrosine kinase inhibitor is tested in combination with a cholinesterase inhibitor and/or memantine. It is being studied in numerous indications in neurology, oncology and virology, including COVID-2019. In Alzheimer's disease, it is its neuroprotective properties that are being studied. The mode of action is threefold, masitinib inhibits microglial cell activity to decrease neuroinflammation, helps maintain blood-brain barrier integrity, and targets the Fyn kinase involved in Tau protein phosphorylation and cascades. signaling triggered by the β-amyloid peptide.
- Lecanemab (Biogen/Eisai/Bioartic): recruitment for phase 3 completed
Lecanemab is a humanized monoclonal antibody directed against β-amyloid peptide aggregates. It would therefore delay the progression of the disease. The clinical trial plans to enroll 1,566 patients and is expected to run through 2024
- Results of the phase 3 clinical trial of ALZT-OP1 (AZTherapies)
ALZT-OP1 consists of the co-administration of two drugs already marketed for other indications: sodium cromoglycate by oral inhalation and ibuprofen in tablet form. Sodium cromoglycate is an antiallergic acting on mast cells while ibuprofen is a nonsteroidal anti-inflammatory. ALZT-OP1 prevents the accumulation of beta-amyloid peptides in mice and stimulates their phagocytosis by microglial cells.
- Results of the phase 3 clinical trial of troriluzole (Biohaven)
Troriluzole is a prodrug of riluzole, a drug used to treat amyotrophic lateral sclerosis. It acts by lowering the level of glutamate at the synapses by increasing the expression of astrocytic transporters such as EAAT2. It is currently being tested as a symptomatic treatment for cognitive symptoms.
- March 7, 2021: deadline for FDA deliberation on Biogen's aducanumab (see newsletter #2)
Aducanumab, already discussed in the previous newsletter, is still under review by the FDA for marketing authorization in the United States. The advisory committee issued a majority negative opinion (out of 11 voters, 10 votes against and one abstention) last October. However, there are a few rare cases where the FDA has gone against the advice of the advisory committee. The first results of additional studies conducted by Biogen, expected in February 2020, could be decisive.
- April 3, 2021: Deadline for FDA deliberation on extension of indication for pimavanserin (ACADIA)
Pimavanserin is a drug used to treat delusions and hallucinations in patients with Parkinson's disease. ACADIA wishes to extend the indication to patients suffering from dementia in the broad sense (including Alzheimer's). - Phase 3 clinical trial results of AVP-786 (Otsuka/Avanir)
AVP-786 is a therapeutic combination of two drugs, dextrometorphan and quinidine. Dextrometorphan is an antagonist of NMDA receptors and an agonist of sigma 1 receptors. Quinidine has the role of increasing the bioavailability of dextromethorphan by limiting its hepatic metabolism and facilitating the passage of the blood-brain barrier by inhibition of the P-glycoprotein The targeted indication is the treatment of moderate to severe agitation in patients suffering from Alzheimer's disease.
- Results of the phase 3 clinical trial of brexpiprazole (Otsuka/Lundbeck)
Brexpiprazole is already used to treat patients with schizophrenia or depression. Current trials aim to test its effectiveness in relieving restlessness in patients with Alzheimer's disease.
- Q4 2021 results of the phase 3 clinical trial (LUCIDITY) of LMTX® (TauRx Pharmaceuticals)
LMTX® is a reduced and stable form of methylthioninium, which is better absorbed and better tolerated than methylene blue. It is an aggregation inhibitor of the Tau protein which would slow the progression of Alzheimer's disease.
Cortexyme is studying a theory according to which Alzheimer's disease is the consequence of an infection with P. gingivalis and the release of "gingipain" toxins in the brain. This company has indeed detected these toxins in almost 100% of the samples studied. Atuzaginstat, an anti-gingipain, is currently being tested at two different doses.
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