Diagnosis, Assessment, and Disease Monitoring Milestones
9.A-9.W, 11.A-11.N
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ID
Title
Status
9.A
Biomarkers: Biomarkers for preclinical/clinical drug development
Develop and validate translatable biomarkers for their use in preclinical and clinical drug development...
Status
In Progress
9.B
Biomarkers: Next generation CNS and biofluid markers
Accelerate the development of the next generation CNS imaging ligands and biofluid molecular signatures...
Status
In Progress
9.C
Biomarkers: Biomarkers for target engagement
Initiate development of imaging and/or fluid biomarkers to demonstrate target engagement for 5 novel therapeutic targets for AD...
Status
In Progress
9.D
Biomarkers: Incorporate biomarkers into Phase 2 trials
Incorporate imaging and/or fluid biomarkers into Phase 2 (proof of concept) drug trials to provide proof of mechanism and/or evidence of target engagement as trials...
Status
Achieved
9.E
Biomarkers: Incorporate biomarkers into Phase 3 trials
Incorporate imaging and/or fluid biomarkers into Phase 3 (pivotal) drug trials to select subjects and/or provide evidence of target engagement...
Status
Achieved
9.F
Biomarkers: Minimally invasive biomarkers
Initiate studies to develop minimally invasive biomarkers for detection of cerebral amyloidosis, AD and AD-related dementias pathophysiology.
Status
Achieved
9.G
Biomarkers: Peripheral blood-based molecular signatures
Initiate studies to link peripheral blood-based molecular signatures and central imaging and CSF biomarkers.
Status
Achieved
9.H
Biomarkers: Early detection measures
Launch research programs to develop and validate sensitive neuropsychological and behavioral assessment measures...
Status
Achieved
9.I
Biomarkers: Standardizing methods
Develop and test methods for the standardization of immunoassays and mass-spectrometry/single reaction monitoring assay...
Status
Achieved
9.J
LBD: Develop biomarkers to detect disease prior to symptom onset
Longitudinal antemortem LBD characterization
Status
In Progress
9.K
Multiple Etiology Dementias: Support research on early detection of cognitive impairment/dementia in everyday settings
Detect cognitive impairment when a patient or relative voices a concern to health care providers.
Status
In Progress
9.L
Multiple Etiology Dementias: Develop differential AD/ADRD diagnosis
Improving differential diagnosis of symptomatic cognitive impairment.
Status
In Progress
9.M
Multiple Etiology Dementias: Establish pre-symptomatic diagnostics and biomarkers
Develop diagnostics/biomarkers in asymptomatic individuals.
Status
In Progress
9.N
Multiple Etiology Dementias: Determine impact of cognitive screening in midlife
Determining the value of screening for clinically relevant cognitive impairment in the absence of a cognitive complaint.
Status
To Be Initiated
9.O
LBD: Develop neuroimaging markers of disease progression
Neuroimaging characterization of LBD
Status
In Progress
9.P
LBD: Biomarker development
LBD biomarker development
Status
In Progress
9.Q
FTD: Biomarker development
Develop FTD biomarkers for diagnosis and disease progression.
Status
In Progress
9.R
VCID: Develop and validate VCID biomarkers
Develop and validate longitudinally tracked noninvasive markers of key vascular processes related to cognitive and neurologic impairment.
Status
In Progress
9.S
FTD: Clinical trials
Develop novel blood/CSF biomarkers or PET ligands for FTLD-tau, -TDP or -FUS during life
Status
In Progress
9.T
TDP-43 in AD/ADRD: Establish biomarkers and dementia risk profiles
Biomarker and risk profiles for TDP-43
Status
In Progress
9.U
Biomarkers: AT(N) in diverse populations
Support systematic evaluation of AT(N) research framework across multi-ethnic populations
Status
In Progress
9.V
Biomarkers: Expand AT(N) framework to ADRDs
Expand the AT(N) framework
Status
To Be Initiated
9.W
Biomarkers: Diagnostic and prognostic algorithms
Develop diagnostic and prognostic algorithms for use in clinical trials and in clinical practice.
Status
In Progress
11.A
Enabling Tech: Technology for in-place monitoring
Develop research programs aimed at evaluating a variety of technologies for in-place monitoring of individuals at all stages of disease...
Status
Achieved
11.B
Enabling Tech: Outcome measures harmonization
Continue to develop standard outcome measures to enable data comparisons across studies...
Status
In Progress
11.C
Enabling Tech: Wearable technologies
Embed wearable technologies as well as pervasive computing approaches in existing and new clinical research...
Status
In Progress
11.D
Enabling Tech: Scalable wearables
Support the development and commericialization of wearables that can increase rigor in measuring environmental exposures and intervention dosing...
Status
In Progress
11.E
Enabling Tech: Secure, high frequency data capture platforms
Build end-to-end secure, high frequency data capture platforms to enable continuous monitoring of research participants...
Status
In Progress
11.F
Enabling Tech: Cognitive assessment repository
Maintain an open-access national repository of evidence -based tools for cognitive assessment...
Status
In Progress
11.G
Enabling Tech: Impact of diagnosis
Launch programs on impact of diagnosis on individuals and families, to include individual response and social impacts.
Status
In Progress
11.H
Health Equity: Develop early cognitive assessment tools for diverse populations
Improve tools for assessment of risks, preclinical characteristics, and costs among health disparities populations by leveraging existing data/cohorts, designing targeted studies, and using psychometric analyses.
Status
In Progress
11.I
Health Equity: Disseminate culturally validated cognitive assessment tools
Increase utilization of culturally- and linguistically-appropriate assessment tools within ongoing and newly generated studies of AD/ADRD and vascular health intervention trials.
Status
In Progress
11.J
Workforce: Train AD/ADRD research and clinical health professionals
Increase training of health professionals to meet the demand for cognitive impairment and dementia diagnosis, care, and need for human-based research.
Status
In Progress
11.K
TBI in AD/ADRD: Diagnosis and clinical measurement of progressive neurodegeneration
Characterize the clinical phenotype of progressive dementia associated with TBI
Status
In Progress
11.L
Multiple Etiology Dementia: Implement interventions for reversible causes
Intervention studies to investigate reversible causes of dementia.
Status
In Progress
11.M
MED-LATE: Differential diagnosis
TDP-43 in AD/ADRD: Differential diagnosis
Status
In Progress
11.N
MED COVID-19: Understanding the impact of COVID-19 on cognitive function
Understanding the impact of COVID-19 on cognitive function
Status
In Progress