Clinical trial: Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects (NCT00870519)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects who have a clinical diagnosis of AD will be recruited for this study

          -  The participant is 50 years or older

          -  Written informed consent is obtained

          -  Participants have a clinical diagnosis of probable Alzheimer's disease based on
             National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's
             Disease and Related Disorders Association (NINCDS/ADRDA) criteria

          -  Subjects will have a clinical dementia rating (CDR) assessment score of ≥ 0.5 and <
             2.0

          -  Modified Hachinski Ischemia Scale score of ≤ 4

          -  For females, non-child bearing potential or negative urine and blood pregnancy test on
             day of 123-I MNI-168 injection

        Exclusion Criteria:

          -  The subject has signs or symptoms of another neurodegenerative disease including
             Parkinson's disease, diffuse Lewy body dementia, or history of significant
             cerebrovascular disease

          -  The subject has clinically significant abnormal laboratory value and/or clinically
             significant unstable medical or psychiatric illness

          -  The subject has any disorder that may interfere with drug absorption distribution,
             metabolism, or excretion (including gastrointestinal surgery)

          -  The subject has evidence of clinically significant gastrointestinal, cardiovascular,
             hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency,
             pulmonary, or other disorder or disease

          -  The subject has participated in another clinical study within the previous 30 days

          -  Clinically significant MRI evidence of vascular disease or alternative neurologic
             disorder

          -  Pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.


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? 1