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Home: Drug Development: Drugs in Clinical Trials
Drugs In Clinical Trials

Important Notice: The Forum does not endorse any medical product or therapy. ALL medications and supplements should be taken ONLY under the supervision of a physician, due to the possibility of side-effects, drug interactions, etc.

Name: COGNIShunt™
Development Status: investigational in U.S.
FDA Phase: Phase II/IIa/IIb
Primary Medical Role: COGNIShunt® System is a cerebrospinal fluid shunt similar but not identical to shunts used for the treatment of children and adults with hydrocephalus. The COGNIShunt® has been engineered specifically to provide a low flow of cerebrospinal fluid (CSF) in individuals without hydrocephalus and is designed to improve CSF clearance without the over drainage of CSF.
Role in Alzheimer's Disease: Cerebrospinal fluid production and turnover diminish with age and may be further diminished in Alzheimer's disease. Flow-regulated drainage of CSF may reduce the accumulation of proteins such as tau and β-amyloid and other inflammatory mediators implicated in AD.
Side Effects: Side effects observed during the clinical trial are similar to other shunt operations, which includes seizures, shunt infection, and headache. All affected individuals recovered from side effects and continued with the trial.
Evidence pro its efficacy: A prospective, randomized study of 29 patients with AD for one year found group mean Mattis Dementia Rating Scale total scores showed little change over the one year in the shunt-treatment group, in contrast to a decline in the control group.
Notes: See ARF related news. See also fact sheet on COGNIShunt from the Alzheimer Association web site.

References

Praticò D, Yao Y, Rokach J, Mayo M, Silverberg GG, McGuire D. Reduction of brain lipid peroxidation by CSF drainage in Alzheimer's disease patients. J Alzheimers Dis. 2004 Aug;6(4):385-389. Abstract

Chakravarty A. Unifying concept for Alzheimer's disease, vascular dementia and normal pressure hydrocephalus - a hypothesis. Med Hypotheses. 2004 ;63(5):827-33. Abstract

Silverberg GD, Levinthal E, Sullivan EV, Bloch DA, Chang SD, Leverenz J, Flitman S, Winn R, Marciano F, Saul T, Huhn S, Mayo M, McGuire D. Assessment of low-flow CSF drainage as a treatment for AD: results of a randomized pilot study. Neurology. 2002 Oct 22;59(8):1139-45. Abstract


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