Nerve growth factor gene therapy for Alzheimer's disease.

Materials and Methods This is a Phase I clinical trial to be conducted in 8 people with early Alzheimer’s disease. Subjects with a diagnosis of probable AD undergo skin biopsies to establish culture of primary fibroblasts. The fibroblasts are then genetically modified to produce and secrete human NGF using retroviral vectors. After verifying production of NGF in vitro, cells are harvested and implanted into the Nucleus Basalis of Meynert using stereotaxic neurosurgery. Subjects are then evaluated every 2 wk to 3 mo for safety (primary end point). In addition, cognitive function is measured.