Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol

  • STATUS
    Recruiting
  • End date
    Jul 9, 2022
  • participants needed
    2000
  • sponsor
    University of Southern California
Updated on 9 May 2021
stroke
depression
estrogen
dementia
antidepressants
alzheimer's disease
anticholinergics
mental state examination
memantine
cholinesterase inhibitors
cholinesterase
apolipoprotein e

Summary

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.

Description

The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia. ADNI3 continues the previously funded AD Neuroimaging Initiative (ADNI1, ADNI-GO, and ADNI-2), and remains a public/private collaboration between academia and industry to study biomarkers of AD. ADNI will continue to inform the neuroscience of AD, identify diagnostic and prognostic markers, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios.

This is multi-center, a non-randomized, natural history, non-treatment study. 1,070-2,000 total participants will be enrolled across three cohorts: cognitively normal* (CN), mild cognitive impairment (MCI) and mild Alzheimer's Disease (AD) dementia. Participants between the ages of 55-90 (inclusive) will be enrolled at 59 sites in the United States and Canada. Approximately, 700 - 800 will be rollover participants from previous ADNI studies, and 370 - 1200 will be newly enrolled. Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across the three cohorts.

Participants will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI scans and cerebral spinal fluid (CSF) collection for up to 5 years.

*currently recruiting non-Caucasian participants only for the cognitively normal cohort.

Details
Condition Dementia, Alzheimer's Disease, Mild Cognitive Impairment, Mild Neurocognitive Disorder, alzheimer, dementia alzheimer's type
Clinical Study IdentifierNCT02854033
SponsorUniversity of Southern California
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age
Normal memory function documented by scoring above education 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)
9 for 16 or more years of education
5 for 8-15 years of education
3 for 0-7 years of education
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)
Clinical Dementia Rating = 0. Memory Box score must be 0
Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
Stability of Permitted Medications for at least 4 weeks
Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years)
Estrogen replacement therapy is permissible
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
Inclusion Criteria (all MCI participants)
Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician
Abnormal memory function documented by scoring below education 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)
< 11 for 16 or more years of education b. 9 for 8-15 years of education c. 6 for 0-7 years of education
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)
Clinical Dementia Rating = 0.5. Memory Box score must be 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 Permitted Medications for at least 4 weeks
Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years)
Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit
Estrogen replacement therapy is permissible
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
Inclusion Criteria (all AD participants)
Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.n
Abnormal memory function documented by scoring below education 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)
8 for 16 or more years of education
4 for 8-15 years of education
2 for 0-7 years of education
Mini-Mental State Exam score between 20 and 26 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director)
Clinical Dementia Rating = 0.5 or 1.0
NINCDS (National Institute of Neurological and Communicative Disorders and Stroke) -ADRDA (Alzheimer's Disease and Related Disorders Association) criteria for probable AD
Stability of Permitted Medications for at least 4 weeks
Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years)
Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit
Estrogen replacement therapy is permissible
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
Inclusion Criteria Specific to Newly Enrolled Participants
Geriatric Depression Scale score less than 6
Age between 55-90 years (inclusive)
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
Visual and auditory acuity adequate for neuropsychological testing
Good general health with no diseases expected to interfere with the study
Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)
Willing and able to participate in a longitudinal imaging study
Modified Hachinski Ischemic Score less than or equal to 4
Completed six grades of education or has a good work history (sufficient to exclude mental retardation)
Must speak English or Spanish fluently
Willing to undergo repeated MRIs (3Tesla) and at least two PET scans
Agrees to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking
Agrees to collection of blood for biomarker testing
Agrees to at least one lumbar puncture for the collection of CSF
Agrees to share genomic data and biomarker samples. Inclusion Criteria Specific to Rollover Participants
The following additional inclusion criteria apply to all diagnostic categories
for rollover participants only
Must have been enrolled and followed in ADNI-1, ADNI-GO, or ADNI-2 for at least one year
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

Exclusion Criteria

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
Exclusion Criteria (all MCI participants)
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
Exclusion Criteria (all AD participants)
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
Exclusion Criteria (all participants)
The following additional exclusion criteria apply to all diagnostic
categories
Screening/Baseline MRI brain scan with evidence of infection, infarction, or other focal lesions or multiple lacunes or lacunes in a critical memory structure
Subjects that have any contraindications for MRI studies, including the presence of cardiac pacemakers, or 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 that could lead to difficulty complying with the protocol
Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder
History of schizophrenia (DSM IV criteria)
History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)
Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol
Clinically significant abnormalities in B12 or thyroid function tests (TFTs) 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
Residence in a skilled nursing facility
Current use of specific psychoactive medications (e.g., certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics). Current use of warfarin or other anticoagulants such as dabigatran, rivaroxaban and apixaban (exclusionary for lumbar puncture)
Current use of any other exclusionary medications
Investigational agents are prohibited one month prior to entry and for the duration of the trial
Participation in clinical studies involving neuropsychological measures being collected more than one time per year
Exclusion Criteria Specific to AV-1451 PET
The following criteria are exclusionary only for the AV-1451 scanning portion
of the study
History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with sudden death) or taking medications known to prolong the QT interval. A list of restricted medications will be provided
Have an ECG obtained prior to the AV-1451 PET scan that in the opinion of the investigator is clinically significant with regard to the subject's participation in the study. Bazett's corrected QT (QTcB) interval must be evaluated and must not exceed 458 msec in males, or 474 msec in females
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