Objective The Clinical Data Interchange Standards Consortium (CDISC) proposed outcome measures for clinical trials on Alzheimer’s disease (AD) in the Therapeutic Area User Guide for AD (TAUG-AD). To investigate how well the clinical trials on AD registered in the ClinicalTrials.gov complied with the recommendations on outcome measures by the CDISC. Methods We compared the outcome measures proposed in the TAUG-AD version 2.0.1 with those employed in the protocols of clinical trials on AD registered in ClinicalTrials.gov. Results We analyzed 101 outcome measures from 305 protocols. The TAUG-AD listed ten scales for outcome measures of clinical trials on AD. The scales for cognition, activities of daily living, behavioral and psychological symptoms of dementia, and global severity listed in TAUG-AD were most frequently employed in the clinical trials on AD. However, TAUG-AD did not include any scale on quality of life. Also, several scales such as Montreal Cognitive Assessment, Alzheimer’s Disease Cooperative Study–Activities of Daily Living, and Cohen- Mansfield Agitation Inventory not listed in the TAUG-AD were commonly employed in the clinical trials on AD and changed over time. Conclusion To properly standardize the data from clinical trials on AD, the gap between the TAUG-AD and the measures employed in real-world clinical trials should be filled.
Objective The Clinical Data Interchange Standards Consortium (CDISC) proposed outcome measures for clinical trials on Alzheimer’s disease (AD) in the Therapeutic Area User Guide for AD (TAUG-AD). To investigate how well the clinical trials on AD registered in the ClinicalTrials.gov complied with the recommendations on outcome measures by the CDISC. Methods We compared the outcome measures proposed in the TAUG-AD version 2.0.1 with those employed in the protocols of clinical trials on AD registered in ClinicalTrials.gov. Results We analyzed 101 outcome measures from 305 protocols. The TAUG-AD listed ten scales for outcome measures of clinical trials on AD. The scales for cognition, activities of daily living, behavioral and psychological symptoms of dementia, and global severity listed in TAUG-AD were most frequently employed in the clinical trials on AD. However, TAUG-AD did not include any scale on quality of life. Also, several scales such as Montreal Cognitive Assessment, Alzheimer’s Disease Cooperative Study–Activities of Daily Living, and Cohen- Mansfield Agitation Inventory not listed in the TAUG-AD were commonly employed in the clinical trials on AD and changed over time. Conclusion To properly standardize the data from clinical trials on AD, the gap between the TAUG-AD and the measures employed in real-world clinical trials should be filled.
INTRODUCTION METHODS RESULTS DISCUSSION
