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WILMINGTON, Del.—Hoping to catch the afflicted before they cascade into the depths of full-blown Alzheimer's, leading global pharmaceutical AstraZeneca and the Mental Health Research Institute (MHRI) in Melbourne, Australia, have teamed up to research innovative ways of identifying the disease in its earliest stage. The ultimate goal of this project is to clear a path toward the discovery and development of drugs that can stem the tide of brain regression in Alzheimer's patients.
Researchers in this joint study plan to find out whether testing cognition at short intervals (every one to three months) over an 18-month period will make it possible to identify individuals just at the point at which they are beginning to suffer cognitive decline.
The study will be conducted in conjunction with the Australian Imaging, Biomarker & Lifestyle Flagship Study of Aging (AIBL), which aims to improve understanding of the causes and diagnosis of Alzheimer's disease and develop preventative strategies.
Alzheimer's is a degenerative brain disease for which there is currently no definitive diagnostic tool. Doctors rely on their clinical judgment to diagnose the disease once it has become symptomatic, but the pathologic process very likely starts a few years beforehand. Affecting 5.3 million Americans, the disease robs its victims of the ability to remember family members.
"Currently, there are no treatments that can prevent, delay or reverse Alzheimer disease and research funding has been stagnant for the past six years," says Harry Johns, president and CEO of the Alzheimer's Association. "With the first baby boomers turning age 65 in just two short years—and entering the arena of increasing risk for developing Alzheimer's—an aggressive plan is needed now to address the threat of this disease. There are too many lives, too little time and too much at stake for anything less."
Lead researcher and eminent neuroscientist Colin Masters, MHRI executive director and laureate professor of the University of Melbourne Department of Pathology, has over the past 30 years studied the disease and discovered the molecular, genetic and biochemical pathways leading to Alzheimer's.
An early diagnosis "would give us hope that the drug therapies will be able to treat Alzheimer's before the debilitating effects take hold," says Masters.
Both MHRI and AstraZeneca "have a strong track record and a large patient cohort for the analysis," Masters said. "MHRI is responsible for carrying out the research and AstraZeneca is in the business of developing drugs which can change the rates of decline (disease modifying therapies)."
This collaboration is unique in the field of Alzheimer's disease in that research is being directed at slope analysis of rates of decline, Masters said. The ultimate goal of the partnership is "to determine the best methods of measuring rates of decline." Researchers hope to accomplish this feat "over the next 12 months," he says.
The collaboration is expected to come up with a more improved detection method by using clinical measures of cognitive decline with neuroimaging and CSF biomarkers, Masters said. Researchers will measure memory and executive functions, and use a PET scan to show direct damage to the brain. Blood tests are not yet available to detect Alzheimer's, he says.
MHRI professor Paul Maruff states, "When assessing cognitive function in an individual at risk for dementia on the first occasion, it is often difficult to determine whether their performance on cognitive tests has declined from some previously higher level. The repeated application of a set of brief and simple cognitive measures could therefore help to identify accurately the point when the onset of Alzheimer's disease was imminent in individual people. This could ultimately lead to a more personalized approach with more effective treatments being given to the right patients at the right time."
Dr. Judith Jaeger, director of Neuroscience Early Clinical Development at AstraZeneca, adds, "We recognize that in addition to searching for new medicines, we urgently need to find new ways to identify those at risk of developing Alzheimer's disease before they begin to experience symptoms. In addition to developing a novel approach to diagnosing cognitive decline, we hope that our collaboration with the world-class researchers at MHRI will provide insights that aid our search for new treatments and ways to prevent disease progression.
"AstraZeneca scientists have been working on developing improved methods for measuring cognitive change in a range of clinical contexts," Jaeger adds. "In joint discussions with Dr. Maruff, the opportunity for using simple, repeatable cognitive measurements to relate rates of change over relatively short intervals to Alzheimer's disease conversion rates in the context of the Australian Imaging, Biomarker & Lifestyle Flagship Study of Aging (AIBL) seemed like a unique opportunity not to be missed."
Conventional clinical neuropsychological tests, which form the basis for most Alzheimer's disease research tools, were not originally designed to measure change, she says. Rather, they were designed to describe an individual's cognitive level relative to a larger population and to aid in diagnosis, she says.
"This will be the first study to our knowledge to monitor cognitive change as frequently as monthly, using instruments that are not subject to improvement from repeated exposure, and that were designed to be sensitive to even small cognitive changes," Jaeger says.
AstraZeneca is developing drugs "that we hope will prevent or forestall deterioration starting at the earliest possible stages of Alzheimer's disease," she says. "Absent a definitive biomarker for imminent cognitive decline, it is hoped that the 'rates of change' study will help us develop methods for identifying those facing decline as soon as the disease is detectable."
The eyes have it
AstraZeneca and Alcon to collaborate on therapies for sight-threatening conditions
HUENENBERG, Switzerland—AstraZeneca announced in August that it has also entered into a five-year, collaborative research agreement with eye health specialist Alcon Inc. to develop lead compounds that already have been identified to have a strong scientific rationale for utility in ophthalmic disease.
The two companies are targeting development of drugs to treat sight-threatening conditions such as glaucoma, wet and dry age-related macular degeneration and other retinal diseases, as well as ocular allergy, dry eye and other inflammatory eye conditions.
Under the terms of the agreement, Alcon obtains immediate access to thousands of AstraZeneca compounds in a variety of drug classes. AstraZeneca will hand over development and regulatory documentation associated with each compound as relevant to ophthalmology. Alcon will perform and fund all research and development activities to move selected compounds forward.
The agreement provides for individual license agreements to be negotiated on a case-by-case basis for any compound that moves into clinical development, including regulatory milestone payments and royalties on product sales. The agreement does not preclude Alcon from pursuing compounds it develops itself or licenses from other companies prior to the initiation of Phase III confirmatory clinical studies.
"Alcon and AstraZeneca share a common goal to use leading-edge science to deliver medicines that will benefit patients," says Jan Lundberg, AstraZeneca's executive vice president of global discovery research. "We are constantly looking for new opportunities to maximize our strong early pipeline, and this collaboration is proof of its value beyond the therapy areas for which AstraZeneca is renowned."
"Our agreement with AstraZeneca stems from our strategy of enhanced access to sources of technologies and compounds through partnership with leading biomedical research organizations," says Dr. Sabri Markabi, Alcon's senior vice president of research and development and chief medical officer. "The combination of AstraZeneca's broad capabilities in discovery and Alcon's scientific expertise in eye disease provides potential for therapies that fulfill unmet medical needs in ophthalmology."