Clinical trial: Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (NMI) (NCT02843529)

Eligibility criteria:
Inclusion Criteria:

          -  Between 55 and 90 years of age

          -  Study partner to accompany patient to all clinic visits for the duration of the
             protocol

          -  Memory complaint by patient and/or study partner

          -  Abnormal memory function score on Wechsler Memory Scale (adjusted for education)

          -  Mini-Mental State Exam score between 24 and 30 (inclusive)

          -  Clinical Dementia Rating = 0.5; Memory Box score at least 0.5

          -  General cognition and functional performance sufficiently preserved such that a
             diagnosis of Alzheimer's disease cannot be made by the site physician at the time of
             the screening visit

          -  Stability of the following permitted medications for 4 weeks (unless stated
             otherwise):

          -  Antidepressants lacking significant anticholinergic side effects

          -  Estrogen replacement therapy

          -  Gingko biloba is permissible, but discouraged

          -  Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics,
             chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to
             screening

          -  Cholinesterase inhibitors and memantine if stable for 12 weeks prior to screening

          -  Geriatric Depression Scale less than 6

          -  Visual and auditory acuity adequate for neuropsychological testing

          -  Good general health with no diseases expected to interfere with the study

          -  Not pregnant, lactating, or of childbearing potential (i.e. women must be two years
             post-menopausal or surgically sterile)

          -  Hachinski less than or equal to 4

          -  Six grade education or has a good work history (sufficient to exclude mental
             retardation)

          -  Fluent in English or Spanish

          -  Agrees to at least one lumbar puncture for the collection of CSF

          -  Willing and able to complete all baseline assessments

          -  Willing to undergo repeated MRIs and at least two PET scans and willing to provide DNA
             and plasma samples as specified

          -  Willing and able to participate in a longitudinal imaging study

        Exclusion Criteria:

          -  Any significant neurologic disease other than suspected incipient Alzheimer's disease,
             such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal
             pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder,
             subdural hematoma, multiple sclerosis, or history of significant head trauma followed
             by persistent neurologic defaults or known structural brain abnormalities

          -  Screening/baseline MRI scans with evidence of infection, infarction, or other focal
             lesions; multiple lacunes or lacunes in a critical memory structure

          -  Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal
             fragments or foreign objects in the eyes, skin or body

          -  Major depression, bipolar disorder as described in DSM-IV within the past 1 year

          -  Psychotic features, agitation or behavioral problems within the last 3 months which
             could lead to difficulty complying with the protocol

          -  History of schizophrenia

          -  History of alcohol or substance abuse or dependence within the past 2 years

          -  Any significant systemic illness or unstable medical condition which could lead to
             difficulty complying with the protocol

          -  Clinically significant abnormalities in B12, or TFTs that might interfere with the
             study

          -  Residence in skilled nursing facility

          -  Current use of specific psychoactive medications (e.g.,certain antidepressants,
             neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); current use of
             warfarin (exclusionary for lumbar puncture)

          -  Use of investigational agents one month prior to entry and for the duration of the
             trial

          -  Exclusion for amyloid imaging with 18F -AV-45: Current or recent participation in any
             procedures involving radioactive agents such that the total radiation dose exposure to
             the participant in any given year would exceed the limits of annual and total dose
             commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section
             361.1

          -  Exceptions to these guidelines may be considered on a case-by-case basis at the
             discretion of the protocol director
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 90 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? Entailment