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From the Departments of Neurosurgery (Drs. Silverberg, Chang, and Huhn and T. Saul), Psychiatry (Dr. Sullivan), Health Research and Policy (Dr. Bloch), Stanford University School of Medicine; the Department of Mechanical Engineering (Dr. Levinthal), Stanford University, Stanford, CA; the Departments of Neurology (Dr. Leverenz) and Neurosurgery (Dr. Winn), University of Washington School of Medicine, Seattle, WA; the Departments of Neurology (Dr. Flitman) and Neurosurgery (Dr. Marciano), Barrow Neurological Institute, Phoenix, AZ; Eunoe, Inc. (Drs. Mayo and McGuire and T. Saul), Redwood City, CA; and the Department of Neurology (Dr. McGuire), University of California School of Medicine, San Francisco, CA.
Address correspondence and reprint requests to Gerald D. Silverberg, MD, Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA 94305; e-mail: geralds{at}leland.Stanford.edu
Objective: This prospective, randomized, controlled study was designed to investigate the safety, feasibility, and preliminary efficacy of long-term CSF drainage via a low-flow ventriculoperitoneal shunt in subjects suffering from AD.
Methods: Twenty-nine subjects selected for probable AD (National Institute of Neurological and Communicative Diseases and Stroke–Alzheimer’s Disease and Related Dementias Association criteria) were screened to exclude normal pressure hydrocephalus or other etiologies of dementia and randomized to treatment (shunt) or no treatment groups. The study endpoint was the comparison of group performance on psychometric testing at quarterly intervals for 1 year. Shunted subjects had CSF withdrawn for MAP-tau and Aß(1-42) assays at the same time intervals.
Results: There was no mortality from the surgical procedure, and no patient sustained a subdural hematoma. Five notable postoperative adverse events, which resolved without permanent neurologic deficit, were reported in the shunt group. Group mean Mattis Dementia Rating Scale total scores showed little change over the year in the shunt-treatment group, in contrast to a decline in the control group (p = 0.06). Mini-Mental State Examination mean scores supported a trend in favor of shunt treatment (p = 0.1). There was a concomitant decrease in ventricular CSF concentrations of AD biomarkers MAP-tau and Aß(1-42).
Conclusions: The surgical procedure and the device are reasonably safe. Adverse events were consistent with shunt procedures for hydrocephalus in this older population. The endpoint data show a trend in favor of the treated group. A larger, randomized, double-blinded, controlled, clinical trial is underway.
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