Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3)

M
Martin Farlow, MD

Primary Investigator

Overview

You are being asked to participate in a research study that will look at the relationship between clinical, cognitive, imaging, genetic and biomarker tests in order to understand the full spectrum of Alzheimer?s disease (AD) from its earliest stages. The data from this research study will be used in the development of future research studies that will focus on the treatment and diagnosis of AD at an early stage.

Description

ADNI3 is a rollover study that will continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research. It will look at the relationship between clinical, cognitive, imaging, genetic and biomarker tests over time, in order to understand the full spectrum of Alzheimer's disease (AD) from its earliest stages.

Eligibility

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

  • Conditions:
    Alzheimer's disease
  • Age: Between 55 Years - 90 Years
  • Gender: All

Inclusion Criteria
Cognitively normal
Participant with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age
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
Mild Cognitive Impairment
Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician
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
Mild Alzheimer's Disease
Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician
Stability of Permitted Medications for at least 4 weeks
Newly Enrolled Participants
Study partner who has frequent contact with the participant 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
Willing and able to participate in a longitudinal imaging study
Completed six grades of education or has a good work history
Must speak English fluently
Willing to undergo repeated MRIs and at least two PET scans
Agrees to collection of blood for genomic analysis, APOE 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
Rollover Participants
Must have been enrolled and followed in ADNI1, ANDIGO, or ADNI2 for at least one year
Willing and able to continue to participate in an ongoing longitudinal study
Exclusion Criteria
Cognitively normal
Any significant neurological 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 neurological deficits or known structural brain abnormalities
Mild Cognitive Impairment
Any significant neurological disease other than suspected Alzheimer's disease
Mild Alzheimer's Disease
Any significant neurological disease other than Alzheimer's disease
All
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 in 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
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 a skilled nursing facility
Current use of specific psychoactive medications
Current use of warfarin or other anticoagulants such as dabigatran, rivaroxaban and apixaban
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


Additional Information:

Updated on 20 Nov 2022. Study ID: 1606238173

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