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.

Datasets included in the database

Study NameContributorParticipantsReferenceNCT
M06-876Abbott102Alzheimer Dis Assoc Disord. 2015 Jul-Sep;29(3):192-9. NCT00555204
AWAREAbbVie*453Alzheimers Dement (N Y). 2025 Nov 22;11(4):e70181. NCT02880956
AWARE EXTAbbVie*364N/ANCT03712787  
SiroccoAstraZeneca164J Alzheimers Dis. 2011;24(2):363-74. NCT00501111
E2020-A001-402Eisai57Neurol. 2004 Dec;61(12):1852-6. N/A
E2020-A001-412Eisai412N/ANCT00293176
E2020-A001-401Eisai137Neurology. 2004 Aug 24;63(4):651-7.N/A
E2020-J081-231Eisai105Dement Geriatr Cogn Disord. 2008;25(5):399-407.NCT00165659
E2020-A001-312Eisai217Neurology. 2001 Aug 14;57(3):481-8.N/A
DON-NY-96-002-324Eisai, Pfizer146Int J Geriatr Psychiatry. 2005 Jun;20(6):559-69N/A
E2020-A001-315Eisai, Pfizer167Neurology. 2007 Jul 31;69(5):459-69. NCT00096473
EXPEDITIONEli Lilly506N Engl J Med. 2014 Jan 23;370(4):311-21.NCT00905372
EXPEDITION2Eli Lilly519N Engl J Med. 2014 Jan 23;370(4):311-21.NCT00904683
EXPEDITION3Eli Lilly1072N Engl J Med. 2018 Jan 25;378(4):321-330.NCT01900665
EXPEDITION EXT*Eli Lilly723N/ANCT01127633
MEM-MD12Forest216JAMA. 2004;291(3):317–324.NA
MEM-MD10Forest202Am J Geriatr Psychiatry. 2006 Aug;14(8):704-15.NA
REFLECT-3GlaxoSmithKline494Curr Alzheimer Res. 2011 Aug;8(5):592-606.NCT00348140
REFLECT-2GlaxoSmithKline500Curr Alzheimer Res. 2011 Aug;8(5):592-606.NCT00348309
REFLECT-1GlaxoSmithKline166Dement Geriatr Cogn Disord. 2010;30(2):131-46.NCT00550420
GAL-INT-11J&J492Neurology. 2008 May 27;70(22):2024-35. NCT00236574
LADDERLundbeck  278Lancet Neurol. 2014 Nov;13(11):1092-1099. NCT01019421
STARSHINELundbeck  933JAMA. 2018 Jan 9;319(2):130-142. NCT01955161
STAR EXTLundbeck  1463N/ANCT02079246
STARBEAMLundbeck  858JAMA. 2018 Jan 9;319(2):130-142. NCT02006641
STARBRIGHTLundbeck  734JAMA. 2018 Jan 9;319(2):130-142. NCT02006654
VITAL (Homocysteine Study)NIA409JAMA. 2008 Oct 15;300(15):1774-83.NCT00056225
GENERATION S1Novartis 427J Prev Alzheimers Dis. 2017;4(4):242-246.NCT02565511
GENERATION S2Novartis 941J Prev Alzheimers Dis. 2017;4(4):242-246.NCT03131453
E2020-A001-302Pfizer162N/AN/A
E2020-A001-311Pfizer105N/AN/A
E2020-A004-304Pfizer274N/AN/A
Nordic StudyPfizer144Neurology. 2001 Aug 14;57(3):489-95.N/A
IQ5-97-02-001 Pfizer 140Dement Geriatr Cogn Disord. 2007;23(1):8-21.N/A
LEADePfizer 326Neurology. 2010 Mar 23;74(12):956-64. NCT00151502
EFC2724 Sanofi719J Nutr Health Aging. 2009 Apr;13(4):365-6.NCT00104013
EFC2946 Sanofi644J Nutr Health Aging. 2009 Apr;13(4):365-6.NCT00103649
CL2-38093-005Servier53N/A2008-007670-37
CL2-38093-009Servier23N/A2009-012035-15
CL2-38093-011Servier179N/A2010-024626-37
CL2-38093-012Servier200N/A2011-005862-40
STEADFASTvTv Therapeutics208J Prev Alzheimers Dis. 2018;5(2):149-154.NCT02080364