Tag Archive for: dementia

Yesterday the agency published a revised draft guidance document, aimed at helping sponsors and pharmaceutical companies to develop therapies for Alzheimer’s disease, particularly in its early stages before the onset of overt dementia.

Although the profile is not precise enough to definitively diagnose Alzheimer’s, it offers a convenient way for doctors to determine which patients need advanced testing, according to the company.

The company said it will prioritize the development of its drug BXCL501, which is being evaluated for use in at-home settings for treatment of agitation related to schizophrenia, bipolar disorders and in patients with mild-to-moderate dementia due to probable Alzheimer’s disease.

Groundbreaking treatments for Alzheimer’s disease that work by removing a toxic protein called beta amyloid from the brain may benefit whites more than Black Americans, whose disease may be driven by other factors, according to leading Alzheimer’s experts.

Quest’s DTC test is aimed at adults aged 18 and older who may have mild memory loss or a family history of Alzheimer’s and want to understand their own risk for the disease.

The proposed guidelines, unveiled by experts on Sunday in a report issued at an Alzheimer’s Association conference in Amsterdam, embrace a numerical staging system assessing disease progression similar to the one used in cancer diagnoses. They also eliminate the use of terms like mild, moderate and severe.

Roche and Eli Lilly are joining forces to develop a blood test for Alzheimer’s disease, and plan to kick off a two-year clinical trial involving hundreds of volunteers with the aim of winning U.S. regulatory approval.

Aptinyx’s NYX-458 fell short of the primary endpoint in a Phase II trial of patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies.

Roche announced its investigational antibody gantenerumab failed to meet the primary endpoints in GRADUATE I and II – two Phase III studies in Alzheimer’s disease.

The agency will expedite its review of Eisai Co Ltd’s (4523.T) and Biogen Inc’s (BIIB.O) experimental Alzheimer’s drug lecanemab, with a decision due by Jan 6, 2023, the companies said on Tuesday.