Clinical trial: Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects (NCT02016560)

Eligibility criteria:
Inclusion Criteria:

        Exploratory Cognitively Healthy Subjects

          -  ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age

          -  Mini-mental state examination (MMSE) ≥ 29

          -  No significant history of cognitive impairment

        Exploratory MCI Subjects

          -  ≥ 50 years of age

          -  MMSE ≥ 24

          -  Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA)
             working group's diagnostic guidelines for AD

          -  Have a study partner that can report on subject's activities of daily living

        Exploratory AD Subjects

          -  ≥ 50 years of age

          -  MMSE > 10

          -  Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines
             for AD

          -  Have a study partner that can report on subject's activities of daily living

        Confirmatory Subjects

          -  ≥ 50 years of age

          -  MMSE ≥ 20 and ≤ 27

          -  Cognitively impaired subjects with either MCI or dementia with a suspected
             neurodegenerative cause

          -  Have a study partner that can report on subject's activities of daily living

        Exclusion Criteria:

          -  Current clinically significant psychiatric disease

          -  Evidence of structural brain abnormalities

          -  History of moderate or severe traumatic brain injury

          -  Current clinically significant cardiovascular disease or ECG abnormalities, or
             additional risk factors for Torsades de Pointes

          -  Current clinically significant infectious disease, endocrine or metabolic disease,
             pulmonary, renal or hepatic impairment, or cancer

          -  History of alcohol or substance abuse or dependence

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity or not using reliable methods of contraception

          -  Have received or participated in a trial with investigational medications in the past
             30 days

          -  Have had a non-study related radiopharmaceutical imaging or treatment procedure within
             7 days prior to the study imaging session.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 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? Entailment