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AstraZeneca, Lilly Begin Alzheimer’s Drug Trial

Illustration of brain (NIDA)

(National Institute of Drug Abuse)

1 December 2014. The pharmaceutical companies AstraZeneca and Eli Lilly and Company began enrolling patients in a clinical trial testing an experimental treatment for Alzheimer’s disease. The intermediate and late-stage trial aims to recruit some 1,550 patients in 15 countries to test safety and effectiveness of the drug code-named AZD3293 against a placebo with patients in early stages of Alzheimer’s disease.

In Alzheimer’s disease, amyloid plaque develops in the brain, breaking down the ability of neurons or nerve cells to function efficiently, leading to death of neurons and shrinkage of brain tissue. Cognitive and memory loss are common symptoms of Alzheimer’s disease, which is the leading form of dementia, affecting more than 5 million people and the 6th leading cause of death in the U.S.

The companies agreed in September to advance AZD3293, into intermediate and late-stage clinical trials as a treatment for people with early symptoms of Alzheimer’s disease. AZD3293 is an oral beta secretase cleaving enzyme, or BACE, inhibitor that aims to prevent the build-up of amyloid plaque toxicity.

The small molecule drug acts by cleaving an amyloid precursor protein that releases and activates peptides inhibiting BACE, which in turn reduces toxicity of amyloid beta peptides making up the accumulating plaque. AstraZeneca tested AZD3293 in early-stage clinical trials, beginning in 2012, which show the drug can reduce levels of amyloid beta peptides in cerebro-spinal fluid of both patients with Alzheimer’s disease and healthy volunteers.

In the new study, Lilly and AstraZeneca plan to enroll 1,551 patients, randomly assigned to receive AZD3293 in doses or 20 or 50 milligrams, or a placebo drug, taken once a day for 2 years or 104 weeks. The patients are 55 to 85 years of age with impairment in memory, both self-reported and a series of objective measures. Participants will also be required to have a positron emission tomography (PET) scan or lumbar puncture to test cerebrospinal fluid for excessive levels of amyloid plaque.

The trial will look primarly at changes in a standard Clinical Dementia Rating scale — measured by semi-structured and in-depth interviews of the patient and his or her study partner — as evidence of AZD3293 effectiveness in treating Alzheimer’s disease, as well as a series of other inventories, scales, and questionnaires. In addition, researchers will compare Alzheimer’s disease biomarkers in cerebrospinal fluid after 97 weeks and amyloid levels in PET scans after 104 weeks for further evidence of the drug’s efficacy.

In the joint-venture deal revealed in September, Lilly agreed to lead further clinical development of AZD3293 (or LY3314814, Lilly’s code name), while the two companies share further commercialization costs and revenues. AstraZeneca will be responsible for manufacturing of the drug.

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