The US Food and Drug Administration (FDA) has issued new guidance on developing drugs for early stages of Alzheimer's disease, before the onset of overt dementia.
The draft, Guidance for Industry, Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease, explains the FDA's opinion on identifying and selecting patients with, or at risk of, early Alzheimer's disease for clinical trials
The FDA Center for Drug Evaluation and Research, Division of Neurology Products director Dr Russell Katz said the scientific community and the FDA believe that it is important to identify and study patients with very early Alzheimer's disease before there is too much irreversible injury to the brain.
"It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients," Katz asaid.
"This draft guidance is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public."
Different methods of indentifying such patients have been tried by the research community in the recent past, using criteria based on biological indicators (biomarkers) in addition to developing sensitive clinical measures designed to aid the detection of hard-to-spot mental decline.
At present, the FDA requires all drugs designed to treat overt dementia to demonstrate an impovement on patient function as well as a reduction in abnormal thinking.
As a result, trials should ensure a beneficial effect on thinking coupled with a clinically meaningful outcome for the patient.
The draft guidance is open for public comment for the next 60 days.