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Alert to Alzheimer's

 

New treatments for Alzheimer’s disease (AD) have been the focus of intensive research efforts over the past few years with the growing appreciation of the healthcare impact that this disease is having on an ageing society. The increase in knowledge of the pathogenesis of this disease has been the basis for many new approaches to treating it, but progression of drug candidates in early clinical trials remains a challenge. Alzheimer’s disease is a presumptive diagnosis, made after the exclusion of other possible sources of dementia. Often, neurodegeneration is slow in the early stages of the disease where the best hope exists to stop or potentially reverse the long-term effects. This results in early clinical studies of long duration in order to provide a meaningful early signal of efficacy. No biomarkers exist yet to replace the complex battery of patient assessment tools that are currently accepted as efficacy endpoints. Managing inter- and intra-subject variability in efficacy measures is a key element in study design and management. Older patients have other health conditions that require therapy, so the design of early clinical studies is fraught with questions of which patients taking what concomitant therapies should be allowed on study. Effective future therapy for Alzheimer’s disease will likely be a combination of drugs that work together to yield a reasonable outcome. Clinical trial designs for combination therapies will be lengthy, large and complex.

THERAPEUTIC APPROACHES FOR ALZHEIMER’S DISEASE

Several very recent reviews have been written on the various therapeutic approaches to AD (1-4). In addition to the products currently available that amplify neurotransmission along key cholinergic and serotoninergic pathways (cholinesterase inhibitors and the NMDA glutamate receptor antagonist, memantine), there are compounds in clinical trials that block the formation of amyloid beta (gammasecretase inhibitors), increase the clearance of amyloid beta (antibodies and vaccines targeted to these proteins) and affect the formation of tau proteins and neurofibril tangles – all histopathological hallmarks of AD. An emerging class of drugs appears to protect neurons from the toxic effects of amyloid-beta and cellular oxidative stress. Interest in agents that enhance cerebral blood flow or improve mitochondrial energy efficiency is built on the knowledge that oxygenation and energy balance in the brain are important in maintaining optimal neuronal function. Neurotrophic stimulation by drugs or gene therapy results in enhanced growth of neurofibrils, and holds the promise of stimulating the development of new neural pathways and perhaps improving cognitive functioning. In addition, the clinical research field is crowded with studies evaluating the potential effects of drugs that reduce inflammation or enhance cellular glucose uptake, as well as analogues of vitamins E and natural dietary supplements such as ginkgo biloba.


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As Vice President of Drug Development at MDS Pharma Services, Fred Pritchard, PhD, leads a team of drug development experts who work actively with clients to bring their drug products from the pharmacology lab into clinical testing in patients. Over the past four years his team has shepherded 12 drugs into the clinic, several of these driven by key biomarkers. Fred brings 27 years of drug development experience to his work, including pre-registration work on five currently marketed pharmaceuticals. He is the author of over 100 scientific publications and abstracts, and is an invited speaker on managing risk during drug development.

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Fred Pritchard
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