Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol: ATRI-001

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Alzheimer Disease
  • Age: Between 55 - 90 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    CN subjects group:
    1. Men and women who are between the ages of 55 and 90 years old
    2. Subjects with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age
    3. Subjects with Normal memory function documented by scoring above education adjusted cutoffs on the Logical Memory II subscale from the Wechsler Memory Scale – Revised
    4. Subjects with Mini-Mental State Exam score between 24 and 30 inclusive
    5. Subjects with clinical Dementia Rating = 0. Memory Box score must be 0
    6. Subjects who are Cognitively normal, basedon an absence of significant impairment in cognitive functions or activities of daily living
    7. Subjects who have stability of Permitted Medications for at least 4 weeks as per the protocol
    MCI subjects group:
    1. Men and women who are between the ages of 55 and 90 years old
    2. Subjects must express a subjective memory concern as reported by participant, or recalled by study partner or clinician
    3. Subjects with abnormal memory function documented by scoring above education adjusted cutoffs on the Logical Memory II subscale from the Wechsler Memory Scale – Revised
    4. Subjects with Mini-Mental State Exam score between 24 and 30 inclusive
    5. Subjects with clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5
    6. Subjects who are 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
    7. Subjects who have stability of Permitted Medications for at least 4 weeks as per the protocol
    AD subjects group:
    1. Men and women who are between the ages of 55 and 90 years old
    2. Subjects must express a subjective memory concern as reported by participant, or recalled by study partner or clinician
    3. Subjects with abnormal memory function documented by scoring above education adjusted cutoffs on the Logical Memory II subscale from the Wechsler Memory Scale – Revised
    4. Subjects with Mini-Mental State Exam score between 20 and 24 inclusive
    5. Subjects with clinical Dementia Rating = 0.5 or 1.0.
    6. Subjects with NINCDS/ADRDA criteria for probable AD
    7. Subjects who have stability of Permitted Medications for at least 4 weeks as per the protocol
    Newly enrolled subjects:
    1. Men and women who are between the ages of 55 and 90 years old
    2. Subjects with Geriatric Depression Scale score less than 6.
    3. Subjects who have study partner who has frequent contact with the participant (i.e., minimum average of 10 hours per week) and is available to accompany the participant to all clinic visits for the duration of the protocol.
    4. Subjects with Mini-Mental State Exam score between 20 and 24 inclusive
    5. Subjects with clinical Dementia Rating = 0.5 or 1.0.
    6. Subjects with NINCDS/ADRDA criteria for probable AD
    7. Subjects who have stability of Permitted Medications for at least 4 weeks as per the protocol
    8. Subjects with visual and auditory acuity adequate for neuropsychological testing.
    9. Subjects who are in good general health with no diseases expected to interfere with the study.
    10. Subjects who are not pregnant, lactating, or of childbearing potential
    11. Subjects with Modified Hachinski Ischemic Score less than or equal to 4.
    12. Subjects who completed six grades of education or has a good work history
    13. Subjects must speak English or Spanish fluently.
    14. Subjects willing to undergo repeated MRIs (3Tesla) and at least two PET scans
    15. Subjects who agree to collection of blood for genomic analysis, APOE testing and biospecimen banking.
    16. Subjects who agree to collection of blood for biomarker testing.
    17. Subjects who agree to at least one lumbar puncture for the collection of CSF.
    18. Subjects who agree to share genomic data and biomarker samples
    Rollover subjects:
    1. Must have been enrolled and followed in ADNI1, ADNIGO, or ADNI2 for at least one year
    2. Subjects who are willing and able to continue to participate in an ongoing longitudinal study.
    3. Subjects willing and able to continue to participate in an ongoing longitudinal study. A reduced battery of tests is allowable if the participant is not able/willing to complete the full battery.

You may not be eligible for this study if the following are true:

  • CN subjects group:
    1. Subjects with any significant neurologic 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 deficits or known structural brain abnormalities
    MCI subjects group:
    1. Subjects with 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 deficits or known structural brain abnormalities.
    AD subjects group:
    1. Subjects with any significant neurologic disease other than 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 deficits or known structural brain abnormalities.



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