New Alzheimer's drug slows the pace of memory loss by over a third

10th October 2012

After a string of recent failures in Alzheimer's trials, researchers have finally achieved a breakthrough.

Alzheimer's, the most common form of dementia, causes progressive decline in memory and other aspects of cognition. Researchers do not know exactly what causes it, and there are currently no approved treatments shown to slow the progression of this devastating disease, only treatment options that reduce certain symptoms. Alzheimer's Disease International (ADI) estimates that there are currently 35.6 million people with dementia worldwide, with 7.7 million new cases each year (which implies one new case every four seconds). On current trends, the number of people affected is estimated to reach 115 million by 2050.

This week, Eli Lilly and Company announced detailed results for its Phase 3, double-blind, placebo-controlled EXPEDITION studies. Patients aged 55-94 years with mild-to-moderate Alzheimer's were eligible to enrol in these studies; EXPEDITION1 enrolled 1,012 patients and EXPEDITION2 enrolled 1,040 patients. Each person received either 400mg of medicine given intravenously, or a placebo, every four weeks for 18 months.

Lilly provided the raw data, pooled from both studies, to the Alzheimer's Disease Cooperative Study (ADCS). Statisticians then performed independent analyses. The results – presented at a meeting of the American Neurological Association in Boston – showed a 34% slowing of cognitive decline compared with placebo.

Dr. Rachelle Doody, M.D., Ph.D.: "Alzheimer's disease research has been extremely challenging. The data results from the solanezumab Phase 3 trials were encouraging to the ADCS team. These results represent an important step for the medical, academic, and scientific communities in understanding brain amyloid as a target of AD therapies."

David Ricks, President of Lilly Bio-Medicines: "This is a complex disease that touches millions of people worldwide. Alzheimer's disease causes significant burden on patients, caregivers and our society. While the path forward has not been determined, we believe these data in patients with mild disease may provide a step toward a potential treatment option."

The new drug, called solanezumab, works to clear the amyloid protein ‘plaques’ thought to cause Alzheimer's. The amyloid hypothesis has been around since 1991, and this drug is believed to offer the first direct evidence that targeting the amyloid cascade can slow progression of the disease. These plaques can start to form years before symptoms develop, however, so researchers are now planning studies of anti-amyloid drugs in people with pre-symptomatic Alzheimer’s.

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