1. The Longitudinal Early‐onset Alzheimer's Disease Study (LEADS): Framework and methodology
- Author
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Apostolova, Liana G, Aisen, Paul, Eloyan, Ani, Fagan, Anne, Fargo, Keith N, Foroud, Tatiana, Gatsonis, Constantine, Grinberg, Lea T, Jack, Clifford R, Kramer, Joel, Koeppe, Robert, Kukull, Walter A, Murray, Melissa E, Nudelman, Kelly, Rumbaugh, Malia, Toga, Arthur, Vemuri, Prashanthi, Trullinger, Amy, Iaccarino, Leonardo, Day, Gregory S, Graff‐Radford, Neill R, Honig, Lawrence S, Jones, David T, Masdeu, Joseph, Mendez, Mario, Musiek, Erik, Onyike, Chiadi U, Rogalski, Emily, Salloway, Steve, Wolk, David A, Wingo, Thomas S, Carrillo, Maria C, Dickerson, Bradford C, Rabinovici, Gil D, and Consortium, the LEADS
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Brain Disorders ,Alzheimer's Disease ,Clinical Research ,Neurosciences ,Dementia ,Neurodegenerative ,Acquired Cognitive Impairment ,Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD) ,Aging ,Biomedical Imaging ,4.1 Discovery and preclinical testing of markers and technologies ,2.1 Biological and endogenous factors ,4.2 Evaluation of markers and technologies ,Detection ,screening and diagnosis ,Aetiology ,Neurological ,Alzheimer Disease ,Aniline Compounds ,Autopsy ,Biomarkers ,Brain ,Cognitive Dysfunction ,Early Diagnosis ,Female ,Humans ,Longitudinal Studies ,Magnetic Resonance Imaging ,Male ,Middle Aged ,National Institute on Aging (U.S.) ,Positron-Emission Tomography ,Stilbenes ,United States ,Alzheimer&apos ,s disease ,early‐ ,onset ,EOAD ,LEADS ,YOAD ,young onset ,LEADS Consortium ,Alzheimer's disease ,early-onset ,Geriatrics ,Clinical sciences ,Biological psychology - Abstract
Patients with early-onset Alzheimer's disease (EOAD) are commonly excluded from large-scale observational and therapeutic studies due to their young age, atypical presentation, or absence of pathogenic mutations. The goals of the Longitudinal EOAD Study (LEADS) are to (1) define the clinical, imaging, and fluid biomarker characteristics of EOAD; (2) develop sensitive cognitive and biomarker measures for future clinical and research use; and (3) establish a trial-ready network. LEADS will follow 400 amyloid beta (Aβ)-positive EOAD, 200 Aβ-negative EOnonAD that meet National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for mild cognitive impairment (MCI) or AD dementia, and 100 age-matched controls. Participants will undergo clinical and cognitive assessments, magnetic resonance imaging (MRI), [18 F]Florbetaben and [18 F]Flortaucipir positron emission tomography (PET), lumbar puncture, and blood draw for DNA, RNA, plasma, serum and peripheral blood mononuclear cells, and post-mortem assessment. To develop more effective AD treatments, scientists need to understand the genetic, biological, and clinical processes involved in EOAD. LEADS will develop a public resource that will enable future planning and implementation of EOAD clinical trials.
- Published
- 2021