COGNIShunt® System for Alzheimer's Disease
Alzheimer Disease
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer disease, Dementia, Ventriculoperitoneal shunt, Tau, ABeta
Eligibility Criteria
Participants must meet National Institute of Neurological Disorders and Strokes, and Alzheimer's Disease and Related Disorders Association (NINDS/ADRDA) criteria of probable Alzheimer's disease of mild to moderate severity. Age at inclusion into study is between 62 and 85 years. Age at onset of symptoms of Alzheimer's disease must be between 60 and 85 years of age. Participants must have no systemic or other brain diseases that could explain deficits in memory or cognition. Imaging studies must be consistent with a diagnosis of Alzheimer's disease. Hachinski Ischemic Rating Scale score of 4 or less. Participants must have sufficient visual and auditory acuity and verbal communication skills to read and hear the testing materials and respond to questions. Participants must be able to read and speak English. Participants must have a responsible caregiver/informant willing to participate in the study. Use of anti-dementia drugs is permitted if participants have been on a stable dose for at least 3 months prior to enrollment. Exclusion Criteria: Family history of early onset Alzheimer's disease. History of recent acute myocardial infarction. Unstable angina. Participants receiving anticoagulants or anti-platelet agents. History of malignancy, active systemic infections, clinically significant respiratory dysfunction and/or liver disease. History of bleeding disorders, uncontrolled diabetes mellitus and/or hypothyroidism. History of stroke. Diagnosis of Normal Pressure Hydrocephalus. Chronic renal insufficiency. History of severe head injury. History of alcohol and/or drug abuse. Positive FTA, low serum B12. Participants exhibiting Parkinsonian signs.