Dementia Research in the News

6th January 2023 – The Alzheimer Society of Ireland Responds to FDA Approval of Lecanemab

The Alzheimer Society of Ireland (The ASI) welcomes the positive decision by the US Food & Drug Administration (FDA) to approve the Lecanemab antibody, which will be marketed as Leqembi, under their accelerated approval pathway. Leqembi targets a harmful protein called amyloid beta in the brain, and data indicates that it has the potential to slow down the progression of Alzheimer’s Disease.*

Leqembi’s accelerated approval was based on Phase II trial data, but in recent months further data from a large Phase III trial was presented by the Japanese Pharmaceutical Company Eisai at the annual Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco. This data supported the earlier results and provided more information on the potential benefits of the drug.

There are currently an estimated 64,000 people with dementia in Ireland, and by 2045, that number is anticipated to increase to 150,000.

Responding to this promising news, The ASI Research and Policy Manager, Dr Laura O’Philbin, said:

“The FDA’s decision to grant accelerated approval of Leqembi is a hugely positive and significant step closer to a credible treatment option for Mild Cognitive Impairment and early Alzheimer’s Disease. In Europe, we expect Eisai to file for marketing approval with the European Medicines Agency by March this year. The world is watching and waiting, and there is no denying that we have entered into a hugely exciting time in the treatment of Alzheimer’s Disease, with news of other drug therapies also expected this year.

It’s important to remember that we still have a way to go as Leqembi will need to go through the FDA’s full traditional process and that this drug will not be suitable for everyone and carries some safety concerns. The Alzheimer Society of Ireland looks forward to continuing to support all people affected by dementia”.

To read the FDA’s Full Statement, please follow this link.

You can also watch The ASI’s Research & Policy Manager, Dr. Laura O’Philbin discuss it’s implications on RTE News here. 

14th November 2022 – The Alzheimer Society of Ireland Responds to Results of Gantenerumab

The Alzheimer Society of Ireland is disappointed to hear that major Phase III clinical trials on the drug gantenerumab did not meet their primary endpoints in slowing down the progress of Alzheimer’s disease.

On 14/11/2022, pharmaceutical company Roche announced top-line results of a major trial on gantenerumab in slowing down Alzheimer’s Disease progress.

Gantenerumab was not shown to significantly slow down the progression of Alzheimer’s Disease in Phase III of the GRADUATE I and II studies, therefore not meeting the primary endpoints.

Gantenerumab is an antibody which targets amyloid in the brain and the level of amyloid removal by the drug was lower than expected.

Further data on the results will be available in November this year at the Clinical Trials in Alzheimer’s Disease conference in the United States.

There are currently an estimated 64,000 people with dementia in Ireland, and by 2045, that number is anticipated to increase to 150,000.

Responding to this news, The ASI Research and Policy Manager, Dr Laura O’Philbin, said:

“This news is not what we had hoped for and will be disappointing for all those impacted by dementia across the world.

However, it’s important to remember that we are now in a space where there are several potential treatments undergoing late stage clinical trials across the world. We received encouraging news about the Lecanemab drug just a few months ago and anticipate other trial announcements in 2023. There will be significant learnings to take away from this and we are heartened to hear that Roche remains committed to Alzheimer’s Disease.”

To participate in all kinds of research, we encourage people with dementia and their families to sign up for TeamUp For Dementia Research.

TeamUp For Dementia Research is a service is provided by The ASI in collaboration with Dementia Research Network Ireland, which helps people affected by dementia learn about and participate in dementia research across Ireland. Please visit our webpage for further information on The Alzheimer Society of Ireland’s research activities or sign up for our research news updates HERE.

The full statement by Roche is available HERE.