Clinical trial: COGNIShunt® System for Alzheimer's Disease (NCT00056628)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 62 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Contradiction