Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria - Newly Enrolled Participants, CN Cohort:
1. Participant may or may not have a significant subjective memory concern as reported by
participant, study partner, or clinician.
2. Normal memory function documented by scoring above demographically-adjusted cutoffs on
the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the
Wechsler Memory Scale - Revised (the maximum score is 25):
1. ≥ 9 for 16 or more years of education;
2. ≥ 5 for 8-15 years of education;
3. ≥ 3 for 0-7 years of education;
4. Note: cut-offs may be modified over time as the field evolves in this area.
3. Mini-Mental State Exam score between 24 and 30 (inclusive) (Exceptions may be made for
participants with less than 8 years of education at the discretion of the Project
Director and/or Clinical Core)
4. Clinical Dementia Rating = 0. Memory Box score must be 0.
5. Cognitively normal, based on an absence of significant impairment in cognitive
functions or activities of daily living.
6. Stability of Permitted Medications for 4 weeks. In particular, participants may:
1. Take stable doses of antidepressants lacking significant anticholinergic side
effects (if they are not currently depressed and do not have a history of major
depression within the past 1 years);
2. Estrogen replacement therapy is permissible;
3. Gingko biloba is permissible, but discouraged;
4. Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening.
Inclusion Criteria for Newly Enrolled Participants, MCI Cohort:
1. Participant must have a subjective memory concern as reported by participant, study
partner, or clinician.
2. Abnormal memory function documented by scoring within the demographically- adjusted
ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only)
from the Wechsler Memory Scale - Revised (the maximum score is 25):
1. ≤ 11 for 16 or more years of education;
2. ≤ 9 for 8-15 years of education;
3. ≤ 6 for 0-7 years of education.;
4. Note: cut-offs may be modified over time as the field evolves in this area.
3. Mini-Mental State Exam score between 24 and 30 (inclusive) (Exceptions may be made for
participants with less than 8 years of education at the discretion of the Project
Director and/or Clinical Core)
4. Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5
5. General cognition and functional performance sufficiently preserved such that a
diagnosis of dementia cannot be made by the site physician at the time of the
screening visit.
6. Stability of Permitted Medications for 4 weeks. In particular, participants may:
1. Take stable doses of antidepressants lacking significant anticholinergic side
effects (if they are not currently depressed and do not have a history of major
depression within the past 1 year);
2. Estrogen replacement therapy is permissible;
3. Gingko biloba is permissible, but discouraged;
4. Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or s;edative hypnotics, etc.) for at least 4
weeks prior to screening
5. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks
prior to screen;
6. Aducanumab and any other approved treatments for the neurobiology of AD if stable
for 24 weeks prior to screen.
Inclusion Criteria - Newly Enrolled Participants, DEM Cohort:
1. Participant must have a subjective memory concern as reported by participant, study
partner, or clinician.
2. Abnormal memory function documented by scoring within the demographically- adjusted
ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only)
from the Wechsler Memory Scale - Revised (the maximum score is 25):
1. ≤ 11 for 16 or more years of education;
2. ≤ 9 for 8-15 years of education;
3. ≤ 6 for 0-7 years of education.;
4. Note: cut-offs may be modified over time as the field evolves in this area.
3. Mini-Mental State Exam score between 20 and 28 (inclusive) (Exceptions may be made for
participants with less than 8 years of education at the discretion of the Project
Director and/or Clinical Core)
4. Clinical Dementia Rating = 0.5 or 1.0.
5. Meets the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines
for Dementia (2011)
6. Stability of Permitted Medications for 4 weeks. In particular, participants may:
1. Take stable doses of antidepressants lacking significant anticholinergic side
effects (if they are not currently depressed and do not have a history of major
depression within the past 1 year);
2. Estrogen replacement therapy is permissible;
3. Gingko biloba is permissible, but discouraged;
4. Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening;
5. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks
prior to screen;
6. Aducanumab and any other approved treatments for the neurobiology of AD if stable
for 24 weeks prior to screen.
Inclusion Criteria - Newly Enrolled Participants, All Cohorts:
1. Geriatric Depression Scale score less than 10.
2. Age between 55-90 years (inclusive).
3. Study partner who has frequent contact with the participant (i.e., minimum average of
2 hours per week) and may be able to accompany the participant to clinic visits or
provide information remotely (e.g. over the phone).
4. Visual and auditory acuity adequate for neuropsychological testing.
5. Good general health with no diseases expected to interfere with the study.
6. Participant is not pregnant, lactating, or of childbearing potential (i.e., women must
be two years post-menopausal or surgically sterile).
7. Willing and able to participate in a longitudinal imaging study.
8. Must be literate and speak English or Spanish fluently.
9. Agrees to collection of blood for GWAS, APOE testing, DNA and RNA testing
10. Agrees to collection of blood for biomarker testing.
11. The Administrative Core, described in section 9.1.1, will collaborate with leadership
from all Cores to review the blood biomarker data from the remote blood cohort and
select participants to join the in-clinic cohort. See ADNI4: Remote protocol.
12. Agrees to participate in the ADNI study which includes cognitive evaluation, MRI and
PET scans.
13. Flexibility can be made to all criteria for those with at least 8 years in a low
socio-economic status (SES) neighborhood.
Inclusion Criteria - Rollover Participants, All Cohorts:
The following additional inclusion criteria apply to all diagnostic categories for rollover
participants only:
1. Must have been enrolled and followed in one of the following previous ADNI studies:
ADNIGO, ADNI2, ADNI3 for at least one year.
2. Willing and able to continue to participant in an ongoing longitudinal study. A
reduced battery of tests is allowable.
3. Study partner may be available who has frequent contact with the participant (i.e.,
minimum average of 2 hours per week), and may be able to accompany the participant to
clinic visits or provide information remotely (e.g. over the phone).
Exclusion Criteria - Newly Enrolled Participants, CN Cohort:
1.Any significant neurologic disease, such as Parkinson's disease, vascular cognitive
impairment/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
Exclusion Criteria - Newly Enrolled Participants, MCI and DEM Cohorts:
1.Any significant neurologic disease other than suspected Alzheimer's disease, such as
Parkinson's disease (Parkinsonian symptoms complicating MCI/AD are acceptable), vascular
cognitive impairment dementia (multiple lacunes less than or equal to 1.5 cm and/or
extensive white matter changes are acceptable), Huntington's disease, normal pressure
hydrocephalus, brain tumor (clinically insignificant meningioma acceptable), 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.
Exclusion Criteria - Newly Enrolled Participants, All Cohorts:
Additional exclusion criteria apply to all diagnostic categories for newly enrolled
participants:
1. Screening/Baseline MRI brain scan with evidence of infection, or other clinically
significant focal lesions. Participants with cortical strokes, not large enough to
distort anatomy, multiple lacunar infarctions or extensive white matter disease are
allowed.
2. Screening/Baseline MRI brain scan with evidence of large structural abnormalities that
would corrupt image analytical pipelines; e.g., large hemispheric infarcts, large
areas of encephalomalacia, large arachnoid cysts
3. Unable to complete MRIs for any reason (e.g., pacemaker or other implanted metal
devices, severe claustrophobia, anxiety which prevents MRI scans, too large to fit,
etc.).
4. Current major depression, bipolar disorder as described in DMS-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.
5. Currently treated with medication for obsessive-compulsive disorder or attention
deficit disorder.
6. History of schizophrenia (DSM-5 criteria).
7. History of alcohol or substance disorder within the past 2 years (DSM-5 criteria).
8. Any significant systemic illness or unstable medical condition which could lead to
difficulty complying with the protocol.
9. Clinically significant abnormalities in B12, or thyroid function tests that might
interfere with the study. A low B12 is exclusionary, unless follow-up labs
(homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not
physiologically significant.
10. Residence in skilled nursing facility
11. Current use of specific psychoactive medications (e.g. certain antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.), at the discretion of
the clinician.
12. Current use of any other exclusionary medications.
13. Investigational agents are prohibited for five half-lives or one month, whichever time
period is longer, prior to entry and for the duration of the trial.
14. Participation in clinical studies involving neuropsychological measures being
collected more than once time per year.
15. Female that is pregnant, lactating, or of childbearing potential.
16. Flexibility can be made to all criteria for those with at least 8 years in a low
socio-economic status (SES) neighborhood.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 9/15/23. Questions regarding updates should be directed to the study team contact.