Available Data
Data Available for Request from API Generation Program: Generation Study 1 (GS1) and Generation Study 2 (GS2)
Overview of Assessments
For more information on study design, please see trial methods paper.
Assessment as described in the Visit Evaluation schedule in the protocol | Data "type" |
---|---|
Informed consent status (including WOC) | Clinical Data |
Inclusion/Exclusion criteria | Clinical Data |
Demographics and baseline characteristics, medical history, current meds/AD family history | Clinical |
APOE Genotype confirmation (done on buccal swab) | Clinical Data |
Blood biomarkers (DNA Pharmacogenetics) | Biosample |
MCI/dementia diagnostic verification/ classification | Clinical Data (Cognitive) |
Physical/Skin/Neurological exam (only recorded in clinical database if Aes applicable) | Clinical Data |
ECG | Clinical Data |
Safety laboratory tests | Clinical Data |
Vital signs | Clinical Data |
Drug Administration | Clinical Data |
MRI (safety, volMRI, fMRI) | Images |
Clinical data assessed from MRI (safety, volMRI, fMRI) (e.g. volumetric, central reads) | Clinical Data |
Amyloid PET | Images |
Clinical data assessed from Amyloid PET (e.g. SUVR) | Clinical Data |
Tau PET (at subset of sites) / FDG PET | Images |
Lumbar Puncture (CSF biomarkers) | Clinical Data & Biosample |
Blood biomarkers (Serum/Plasma) | Biosample |
Blood biomarkers (RNA Pharmacogenomics) | Biosample |
RBANS (APCC), Raven's (APCC), MMSE | Clinical Data (Cognitive) |
CDR, Ecog, NPI-Q | Clinical Data (Cognitive) |
Lifestyle questionnaire, GDS, QOL-AD | Clinical Data (Cognitive) |
Adverse events (including dermatological for CNP520) / eC-SSRS/Concomitant medications | Clinical Data |
Available Data
Screening and longitudinal data including demographics, neuropsychological testing, neuropsychological examination, cognitive testing, and neuroimaging data is available.
Full dataset is available by request from University of Southern California Laboratory of Neuroimaging (USC LONI).
Full clinical dataset (without imaging data) is available by request from Alzheimer’s Disease Data Initiative (ADDI) AD Workbench.