Notice of Information: Alignment Among the Disease Definitions Utilized to Govern Genetic and Genomic Data Sharing for Studies Involving Alzheimer's Disease

Notice Number: NOT-AG-17-007

Key Dates
Release Date: May 1, 2017

Related Announcements
None

Issued by
National Institute on Aging (NIA)
National Institute of Neurological Disease and Stroke (NINDS)

Purpose

BACKGROUND:

This Notice updates the disease definitions accepted within the broad concept of Alzheimer's disease as it applies to sharing samples and data, to informed consent, and as it relates to scientific discovery in Alzheimer’s disease research. It aligns the Alzheimer's disease concept with the term as used in the National Alzheimer's Project Act (NAPA) and Public Law 111-375. The community of scientists performing studies on dementia identified the need for this update. The Notice's primary intent is to define the scope of application of the language as it can be used in requests to access data through NIH-approved data storage sites and in recruitment of subjects into studies.   

IMPLEMENTATION:

The NIH developed a procedure to obtain community participation in the language alignment. A consensus was reached with and approved by the Alzheimer's Disease Sequencing Project (ADSP) investigators and institutions. Based on the state of the science, NIH is supportive of the update. 

Under NAPA, Alzheimer’s disease is defined to include the Alzheimer’s Disease Related Dementias (ADRDs) in research and other activities that will lead to a decrease in the growing public heath burden caused by dementia in our aging population (see NAPA 2012 2013, and NAPA 2016). The National Plan to address Alzheimer’s disease defines ADRDs to include dementia due to: 

1.    Frontotemporal Dementia (FTD) including Frontotemporal Lobar Degeneration (FTLD), Primary Progressive Aphasia (PPA), Progressive Supranuclear Palsy (PSP), Corticobasal degeneration (CBD) and Pick’s Disease
2.   Lewy Body Dementia (LBD) including Dementia with Lewy Bodies (DLB), and Parkinson’s Disease Dementia (PDD)
3.   Vascular Dementia including vascular dementia, vascular cognitive impairment (VCI), multi-infarct dementia, post-stroke dementia, and vascular brain injury
4.   Mixed pathologies
5.   Down syndrome

This update to the Alzheimer’s disease definition will apply to studies already submitted to NIH-approved data storage sites such as dbGaP and the NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS), as well as to new and existing studies that will be submitted to these and other approved data storage sites. The update is supported by scientific advances over a number of years in understanding the variety of pathologies and genetic influences that give rise to the full spectrum of dementia in those diagnosed with AD.

Therefore, effective with the date of release of this notice, NIH will begin permitting access to data with an “Alzheimer’s disease only” data use limitation if the data access request includes research on Alzheimer’s disease or the ADRDs delineated above. Updating the definition of Alzheimer's disease used to establish data-sharing criteria will allow advancement of research on dementia-causing disease processes that are commonly embedded in and/or are difficult to distinguish from AD during life. This clarification will allow approved users of Alzheimer's disease genomic data to pursue research that is fully congruent with the NAPA definition and the current state of the science in the field.

Inquiries

Please direct all inquiries to:

Marilyn Miller, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350 
Email: millerm@nia.nih.gov

Roderick Corriveau, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: roderick.corriveau@nih.gov