Clinical trial: Study on Biomarkers for Early Diagnosis of Alzheimer's Disease (NCT04575337)

Eligibility criteria:
Inclusion Criteria:

          -  Written informed consent obtained from participant or legal guardian prior to any
             study-related procedures.

          -  Aged 18 (inclusive) or older.

          -  Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
             (DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and
             Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders
             Association (NINCDS- ADRDA) or National Institute on Aging and the Alzheimer's
             Assocation (NIA-AA) criteria. A diagnosis of mild cognitive impairment (MCI) is
             assigned according to Petersen criteria. A diagnosis of pre-MCI group is assigned by
             β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment, but not up
             to MCI or cognitive impairment. Normal cognitive function assessed/evaluated by MMSE,
             CDR and other cognitive function scales.

          -  Follow up 5 years and collect the information.

        Exclusion Criteria:

          -  Under age 18.

          -  Medical or psychiatric illness that would interfere in completing initial and
             follow-up visits.

          -  No one can serve as a study informant.

          -  With current or past neurological or psychiatric illnesses such as schizophrenia,
             epilepsy, brain tumors, severe head trauma and other diseases which can induce
             dementia.

          -  Refused to complete a cognitive test and provide biospecimen.

          -  With history of alcohol or drug abuse.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 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