2023

The topline results for the Anti-Amyloid treatment in Asymptomatic Alzheimer’s disease (A4) study were released today (https://a4study.org). Unfortunately, the drug being investigated, solanezumab, failed to demonstrate a benefit in slowing memory changes in a population of individuals age 65-to-85 who met criteria for preclinical Alzheimer’s disease. Preclinical Alzheimer’s is a relatively new construct. It includes people who are older and have normal memory performance, but in whom biological tests suggest that the risk for Alzheimer’s disease dementia is high. The A4 study was among the first ever preclinical AD trials, boldly blazing a trail that has now been followed by…

On February 17, 2023, a bipartisan group of Senators sent the Secretary of Health and Human Services, Javier Baccera, and the Administrator of the Centers for Medicare and Medicaid Services (CMS), Chiquita Brooks-LaSure, a letter requesting that CMS reconsider their decision to require Coverage with Evidence Determination (CED) that was levied after the accelerated approval of aducanumab. The letter followed a similar request from the Alzheimer’s Association, made in December 2022. The CED decision significantly limited access to aducanumab and other monoclonal antibodies (should they be approved), requiring that coverage would be granted only if Medicare beneficiaries were enrolled in…

Frontotemporal dementia (FTD) is a form of dementia that typically affects individuals in their 50s and 60s. It is therefore, commonly referred to as young onset dementia. Clinically, FTD can present in two ways; some patients present with behavioral impairment and are referred to as behavioral variant FTD (bvFTD). The other main presentation involves language decline and is called primary progressive aphasia (PPA). Both conditions start insidiously and accurate diagnosis can be a challenge, especially at early stages of the disease. In bvFTD, patients can present with apathy, lack of empathy, increased appetite, preference for sweet tooth, new onset of…

In a somewhat surprising move, the US Food and Drug Administration (FDA) has declined to grant accelerated approval to Eli Lilly’s donanemab Read the full press release from Eli Lilly here Like aducanumab and lecanemab, which were previously granted accelerated approval by the FDA, donanemab is a monoclonal antibody treatment against the beta amyloid protein that accumulates in the brain of a person with Alzheimer’s disease. Eli Lilly published very promising results for donanemab in 2021, which included demonstration that donanemab could lower amyloid levels in the brain of people with mild cognitive impairment and mild dementia (the basis for…

January 6, 2023 – Today, as expected, the US Food and Drug Administration granted accelerated approval to lecanemab, a monoclonal antibody against the beta amyloid protein that accumulates in the brain of people with Alzheimer’s disease. Lecanemab was approved on the basis of the treatment’s demonstrated effect of lowering levels of brain amyloid, as measured by a type of brain scan known as positron emission tomography (PET) imaging. Lecanemab is now approved for the treatment of patients with mild cognitive impairment or mild dementia, and should be used in patients in whom that same amyloid PET brain scan (or measures...