|
 Even as pharmaceutical companies are increasingly focusing on the discovery and validation of biomarkers for Alzheimer's disease (AD), the lack of effective drugs to treat this neurological disease is indeed a significant challenge in healthcare. Despite extensive efforts and investment in drug development, no therapy has yet been able to halt or reverse the progression of AD.
It is here the industry appreciates the purpose of the latest US FDA guidance which is seen to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic AD.
Numerous clinical trials testing potential Alzheimer's drugs have failed to demonstrate efficacy, leading to setbacks and discouragement in drug development efforts, said clinical experts at National Institute of Mental Health and Neuro Sciences.
Now we see this guidance is intended to serve as a focus for continued discussions among representatives of the Office of Neuroscience in the Center for Drug Evaluation and Research or the Office of Therapeutic Products in the Center for Biologics Evaluation and Research, as appropriate, pharmaceutical sponsors, the scientific community, and the public about the development of drugs for the treatment of early AD.
Usually clinical criteria that defined later stages of AD, after the onset of overt dementia, were used for enrolment in clinical trials. Accordingly, subjects included in these trials exhibited both the cognitive changes typical of clinically evident AD and the degree of 45 functional impairment associated with overt dementia, said US FDA in is guidance.
Drugs that were approved for dementia were evaluated. As the scientific understanding of AD has evolved, efforts have been made to use of biomarkers to assess the underlying pathophysiological changes in clinical trials. The enrolment of subjects were those with AD at earlier stages of the disease, in which there may be minimal or no detectable abnormality on clinical assessments.
The global regulatory authority said that eligibility for enrolment in trials to treat early AD should be based on current consensus diagnostic criteria. This approach is intended to avoid enrolment of a substantial number of subjects who would not actually have AD.
We support the use of biologically based diagnostic criteria that are grounded in a contemporary understanding of the pathophysiology and evolution of AD. The characteristic pathophysiological changes of AD precede, often by many years or even decades. The development of clinically evident findings can be categorized into stages. Based on knowledge gained from previous clinical trials and the evolving understanding of the pathophysiology of AD, there is an increased focus on evaluating drug treatments in the earliest stages of the disease. Diagnostic criteria that reliably define a population with early AD, including the earliest stages characterized only by pathophysiological changes, are suited to the evaluation of drugs intended to delay or prevent the emergence of overt symptoms, said the global regulatory authority.
With the issuance of the guidance, pharma industry noted that this was invaluable for developing drugs for Alzheimer’s disease.
|