Critical Path For Alzheimer’s Disease (CPAD) Database

The database contains, but is not limited to, demographic information, APOE4 genotype, concomitant medications, and cognitive scales (MMSE and ADAS-Cog). Limited treatment-arm data and limited AD biomarker data (biofluids, tau or amyloid positron emission tomography (PET), EEG data) is available. All data has been remapped to a common data standard (CDISC SDTM v3.1.2) such that all the data can be analyzed across all studies.

New users may apply for access via the button to the left, while existing users may log in via the button to the right.

FAQs

What is in the Database? FAQ Icon

Patient-level data from 12,811 patients across 36 clinical trials of AD and MCI. The database contains, but is not limited to, demographic information, APOE4 genotype, concomitant medications, and cognitive scales (MMSE and ADAS-Cog). Limited treatment-arm data and limited AD biomarker data (biofluids, tau or amyloid positron emission tomography (PET), EEG data) is available. All data has been remapped to a common data standard (CDISC SDTM v3.1.2) such that all the data can be analyzed across all studies. It is openly available to CPAD members, as well as to external qualified researchers who submit, and are approved for, a request for access. All data are fully de-identified.

What is Not in the Database? FAQ Icon

Exact names of test drug candidates from sponsor companies.

How the data are standardized? FAQ Icon

The data are mapped to the CDISC foundational and AD-specific Study Data Tabulation Model (SDTM). Knowledge of SDTM is required for effective use of the data. Information and training on SDTM is available from CDISC: no SDTM training is provided within CODR.

The data consists of 33 SDTM domains. A summary of the more salient concepts captured by SDTM domains contained in the CPAD AD database is provided in the table below. Please note that not all studies have complete data for these data.

CDISC Domain Contents
DM Age
Sex
Race
Ethnicity
Country
CM **Acetylcholinesterase Inhibitors
**Memantine
**General Medications
AE ***Event
Severity
Duration
MH General Medical History
AD\MCI Diagnosis
VS SBP, DBP
Heart Rate
Temperature
Weight, Height
BMI
Respiratory Rate
QS ADAS-Cog
MMSE
ADCS-ADL
NPI
CDR (Limited Number of studies)
Others as collected may be present
LB All labs collected, mapped to SDTM.Fluid biomarkers (limited data available)
PF *ApoE Genotype
NV MRI (limited data available)
Amyloid and FDG – PET (limited data available)
XD Information about Alzheimer’s Disease and Symptom duration
*ApoE = Apolipoprotein E; **Memantine and AChEi drug names are standardized in the CMDECOD field. All other drug names are provided in the verbatim terminology supplied to CPAD.

 

What is the Intended Application? FAQ Icon

Serves as a tool for the development of modeling and simulation tools for AD clinical trials; and

Item level data of clinical scales is present allowing investigators to analyze sub-items for specific analyses.

What Are the Basic Requirements? FAQ Icon

A working knowledge of SDTM (www.cdisc.org) is required to make use of the data.

Take time to explore the Resources tab within the database to get better acquainted with the database and its functionality.

What is the Availability of Trial-level Metadata? FAQ Icon
In accordance with the Data Contribution Agreements, CPAD is obligated to protect the identity of the individual datasets and provides access to the datasets only in aggregate. Per this requirement, we are unable to provide the identity of individual studies in the CPAD CODR database and we are unable to provide protocols, publications, or clinicaltrials.gov record locator numbers for the trials contained in the database. Anonymizing data sources in this manner has implications in analysis when the user needs specific information about patient population and/or study design that is not included in the data. However, users should be able to determine characteristics such as baseline MMSE scores (where applicable; this can serve as an indicator of severity of impairment at enrollment), gender and age distribution, frequency and timing of follow-up visits and assessments, and trial duration.