Rules must evolve to allow new drugs for early Alzheimer's

Rules must evolve to allow new drugs for early alzheimer's
Given the shift in the focus of drug development for Alzheimer's disease toward earlier disease stages, before the onset of dementia, regulatory guidelines need to evolve, according to a perspective piece published online March 13 in the New England Journal of Medicine.

(HealthDay)—Given the shift in the focus of drug development for Alzheimer's disease toward earlier disease stages, before the onset of dementia, regulatory guidelines need to evolve, according to a perspective piece published online March 13 in the New England Journal of Medicine.

Noting that in reviewing new-drug applications for the treatment of Alzheimer's disease, the U.S. has maintained that improved cognition should be accompanied by evidence of improvement in function, Nicholas Kozauer, M.D., and Russell Katz, M.D., from the FDA in Silver Spring, Md., discuss the implications for drugs designed for use in the early stages of Alzheimer's disease.

According to the authors, drug development is increasingly shifting to earlier stages of Alzheimer's disease, before the onset of overt dementia. In recognition of this, the FDA has developed guidelines for conducting clinical trials for patients who do not present with dementia. The guidelines suggest use of a single scale that combines cognition and function. For patients with disease at an early clinical stage, before , this might allow approval of a drug based on cognitive outcome alone. Accelerated approval of such drugs could be conditional on post-approval studies, which would verify the .

"As the focus of drug development has shifted to earlier stages of Alzheimer's disease, many new and challenging scientific questions have emerged, and the regulatory framework under which such therapies are evaluated should evolve accordingly," the authors write.

More information: Full Text

add to favorites email to friend print save as pdf

Related Stories

Pfizer and J&J end development of Alzheimer's drug

Aug 06, 2012

Pfizer Inc. and Johnson & Johnson say they are ending development of a once-promising drug designed to treat Alzheimer's disease after the treatment failed in two late-stage clinical trials.

New research supports upcoming Alzheimer's disease guidelines

Aug 01, 2011

Two new studies published in the August issue of The Journal of Nuclear Medicine (JNM) provide insight into the potential of positron emission tomography (PET) to differentiate between types of dementia and to identify pharma ...

Recommended for you

Cold sores increase the risk of dementia

Oct 20, 2014

Infection with herpes simplex virus increases the risk of Alzheimer's disease. Researchers at Umeå University, Sweden, claim this in two studies in the journal Alzheimer's & Dementia.

User comments