2023-07-22 04:00:00
The results of clinical trials of a new drug that can slow Alzheimer’s disease have brought a wave of hope in the fight once morest this scourge, which destroys brain cells.
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Unveiled with great fanfare this week at an international conference devoted to Alzheimer’s disease in Amsterdam, the Netherlands, the results show that donanemab might reduce cognitive decline by around 30% over 18 months.
This is the third drug to emerge in recent years, marking the beginning of a small revolution once morest Alzheimer’s, a degenerative and irreversible disease, following decades of research. “It arouses a lot of hope, a lot of enthusiasm,” confirms the executive director of the Alzheimer Society of Montreal, Jeane Day.
ALZHEIMER SOCIETY OF MONTREAL
How does the drug work? When will it be available? And who can get it? Many uncertainties remain, but here are the answers obtained by The newspaper.
It slows down, it doesn’t heal
The Dr John Sims of Eli Lilly Pharmaceuticals was adamant. The drug donanemab does not cure Alzheimer’s disease.
Nevertheless, the results of phase three clinical trials on more than 1700 patients, published in the Journal of the American Medical Association (JAMA), are conclusive when the drug is taken very early.
Donanemab slowed disease by 35% in participants with low or medium protein levels. The accumulation of this protein in the brain is associated with the onset of the disease.
- Listen to the interview with Paolo Vitali, neurologist on the Alexandre Moranville-Ouellet show via QUB radio :
Donanemab specifically targets deposited amyloid plaques found in neurons affected by neurodegenerative diseases. The treatment reduced amyloid plaques by an average of 84% following 18 months.
“This is certainly great news in the field. […]. A drug that acts biologically on the plaques,” says Douglas Institute neuropsychiatrist and researcher at the Montreal Neurological Institute, Dr.r Simon Ducharme. Because currently, care is limited to trying to control and reduce the risk factors of the disease, he continues.
“It’s a small step forward, but not a miracle,” adds neurologist specializing in cognitive function, Christian Bocti, from the University of Sherbrooke.
Dr. Simon Ducharme is also head of the memory clinic at the Douglas Institute.
Courtesy The Neuro
Patience remains
The pharmaceutical company Eli Lilly, behind this new drug, has applied for approval in the United States, from the Food and Drug Administration (FDA), and expects a response by the end of the year.
It will then be necessary to wait another 12 to 18 months before approval by Health Canada, which usually follows the large markets of the United States and Europe. In Quebec, the National Institute of Excellence in Health and Social Services (INESSS) will also have to study the drug to recommend whether it can be reimbursed by the public plan and who would be entitled to it.
Marie Christine Le Bourdais, director of programs and services at the Alzheimer Society of Montreal, in conversation with one of the participants at the Amsterdam conference.
ALZHEIMER SOCIETY OF MONTREAL
heavy side effects
Donanemab would not be for all patients, warns the Dr Simon Ducharme, who warns of reported side effects.
Three patients died in clinical trials. The drug can cause serious side effects, such as swelling or bleeding in the brain.
“It’s going to be a drag on demand, when people are going to notice the risk-benefit,” says the doctor, regarding the inflammatory reaction caused by the drug.
The Dr Ducharme points out that it is also still too early to know the impact of the drug beyond 18 months, to know if the slowing down of the disease can be maintained and can last, or if the patients will reach a plateau.
“It’s a modest effect for significant side effects,” argues Dr. Bocti.
The bill will be salted
“It’s going to be expensive, that will be the other issue, cost-efficiency,” continues the Dr Ducharme.
Even if the cost in Canada is likely to be lower than that of the United States, there is already talk of a bill of more than $30,000 per year for donanemab.
“I expect that [le médicament] comes with very strict criteria”, underlines the specialist.
Because the results are positive on a specific population, he says, that is to say people very early in the disease. “People aging have mixed dementias, with multiple causes,” he adds, doubting they can benefit from the drug.
Since it is also an intravenous drug, its distribution to patients will require more logistics within the health network than a simple pill.
Two other drugs
If approved, donanemab will be the third drug to be introduced recently.
A Japanese pharmaceutical recently got FDA approval for Leqembi, which also slows Alzheimer’s disease in a similar way.
The FDA also approved Aduhelm, but it was rejected in Europe because of criticism of its effectiveness.
None are yet approved in Canada.
For Jeane Day, of the Alzheimer Society of Montreal, these drugs open the way to a better quality of life and to the maintenance of autonomy for patients. Describing the disease as a public health issue, she invites the authorities to look proactively at these drugs and their distribution.
For Dr. Bocti, the arrival of new drugs, whose effectiveness remains limited, means that a “cocktail of varied interventions” remains the best way to fight once morest the disease and that it is especially necessary to improve its early detection.
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