Thursday, May 20, 2010

Alzheimer patients to get nerve growth factor directly injected into brain

The Alzheimer’s Disease Cooperative Study, a 19 year project funded by the NIA, has embarked on a clinical trial that delivers Nerve Growth Factor (NGF) directly into the brain as a possible treatment for Alzheimer’s.
A Phase II clinical study of Ceregene's CERE-110, a gene therapy product designed to deliver nerve growth factor (NGF) to the brain for the treatment of Alzheimer's disease (AD) is currently in progress.

This Phase II study is a randomized, double blind, placebo-controlled trial and employs gene therapy to deliver nerve growth factor (NGF) directly into the brain. The rationale behind this study is that NGF is known to promote survival of cholinergic neurons, that degenerate in AD, and therefore may provide sustained functioning of these neurons. Direct delivery of CERE-110 into the brain aims to selectively target the Nucleus Basalis of Meynert (NBM), where cholinergic neuronal degeneration occurs in AD.

A Phase I study at Rush University and the University of California San Diego indicated that a single administration of the therapy was generally safe and well tolerated. The Phase I participants underwent cognitive testing, measures of activities of daily living, MRI scans and PET (positron emission tomography) scans. Increases in brain metabolism were observed in several cortical regions of the brain at six months and 12 months in some of the subjects, as compared to other severity-matched individuals with AD, suggesting a potential reversal of patterns typically observed in AD.

This Phase II study will examine the safety and effectiveness of NGF on Alzheimer's disease in 50 patients at 11 research sites throughout the United States. All eligible participants will be randomized equally to one of two treatment groups: half of the subjects will initially receive placebo surgery, but no administration of gene therapy. In the other half, CERE-110 will be injected into the NBM of the brain. At the completion of the trial, subjects in the placebo arm will be given the opportunity to switch to the active treatment protocol if the efficacy and safety data are supportive.
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Anonymous said...

A few in medicine have previously expressed interest and concern about just how many of the protein misfolding disorders including the amyloidopathies might be transmissible. I can only hope that great caution is being utilized with experimental treatments such as this. Ideally this would and should include disposable neurosurgical instruments.

Anonymous said...

alzheimer's a prion disease? that's laughable.