Alzheimer's


Alzheimer’s Therapeutic Area User Guide v2.0

Version 2.0 of the Alzheimer’s Disease Therapeutic Area User Guide (TAUG-Alzheimer's) was developed under the CDISC Standards Development Process. TAUG-Alzheimer’s v2.0 describes the most common biomedical concepts relevant to studies of Alzheimer’s disease and mild cognitive impairment, and the necessary metadata to represent such data consistently with Terminology and SDTM.

TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints. 

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process. 

 

Files
Alzheimer’s Therapeutic Area User Guide v2.0
Alzheimer’s Therapeutic Area User Guide v2.0 Public Review Comments

Links
Accelerating drug development for Alzheimer’s disease through the use of data standards
Consensus Clinical Data Standards for Alzheimer’s Disease- Focus on Prevention Trials
Development of a unified clinical trial database for Alzheimer’s disease
The Future Is Now: Model-Based Clinical Trial Design for Alzheimer’s Disease
Published User Guides
Terminology
SDTM


Articles
Examples
Known Issues

All Public Reviews
QRS Supplement to ADaMIG: Geriatric Depression Scale Short Form
Comments Due by:
ADaM Conformance Rules v3.0
Comments Due by:
Controlled Terminology Package 43 Public Review
Comments Due by:

Partnerships

The Coalition Against Major Diseases (CAMD) used CDISC standards to develop a database that enables pooling of data from different sources to create an Online Data Repository for Alzheimer’s with the aim of supporting accelerated drug development.

Alzheimer’s Disease trial simulation tool  was built using CDISC standardized data allows researchers to optimize the design of new trials.


Alzheimer's Therapeutic Area User Guide v1.0