Researchers at UCLA in the USA have developed the first non-invasive diagnostic test for Alzheimer's disease.
The new technique, soon to undergo clinical trials, could help with the early diagnosis of Alzheimer's disease as well as tracking disease progression. Currently, there is no diagnostic test for Alzheimer's and clinical trials rely on cognitive end-point tests.
The test could also greatly increase the speed of clinical trials of new drugs, greatly increasing the efficiency of Alzheimer's drug development, speeding the current generation of Alzheimer's drugs along the pipeline.
Commenting on the new technique to DrugResearcher.com, Professor Clive Ballard, Alzheimer's Society director of research, said: "This new research could prove significant in the early diagnosis of Alzheimer's disease. The ability to diagnose at the earliest possible stage is of huge importance to people with Alzheimer's disease."
"This exciting study aims to track the progression of Alzheimer's disease by imaging amyloid using PET (positron emission tomography) scan. Amyloid is the protein at the core of plaques which are known to occur with the onset of Alzheimer's disease, and we look forward to further developments in this area of research."
Neuropathological studies have shown that beta-amyloid and another protein called tau, accumulate in abnormal patterns during ageing and particularly during the onset of Alzheimer's disease. The build-up of these lesions may even begin before the age of 30.
The technique, described in the 21 December 2006 issue of the New England Journal of Medicine, works by the intravenous injection of a Fluorine-18 labeled short-lived radio-tracer molecule FDDNP, that specifically binds to the amyloid protein. The radio-tracer molecule can then be located using positron-emission topography (PET).
The study indicated that patients with Alzheimer's disease have a significantly higher retention of FDDNP biomarker in the brain than control subjects or dementia sufferers. The FDDNP-PET scan showed considerably better differentiation between sufferers and non-sufferers than magnetic resonance imaging and PET scans using other imaging agents.
The technique has been licensed by UCLA to Siemens, which plans to begin clinical trials under an investigational new drug (IND) application agreed by the Food and Drug Administration (FDA).
A spokesperson for the Alzheimer's society told DrugResearcher.com that approximately 55 per cent of the 18m worldwide dementia sufferers have Alzheimer's disease and this number is predicted to grow to 34m by 2050.