Across 56 unique European Alzheimer’s and dementia Phase II, Phase II/III, and Phase III CTIS-authorized trials, safety and tolerability endpoints are the dominant measurement family, appearing in 34 trials (60.7%). Blood or cerebrospinal-fluid biomarkers appear in 23 trials (41.1%), followed by Clinical Dementia Rating / CDR-SB in 17 trials (30.4%), MRI or structural neuroimaging in 15 trials (26.8%), and ADAS-Cog in 14 trials (25.0%). The endpoint pattern splits into two major designs: disease-modifying Alzheimer’s trials emphasize biomarkers, CDR, ADAS-Cog, amyloid/tau imaging, and function, while neuropsychiatric AD trials emphasize NPI-C, CGI, and CMAI.
Safety / tolerability is the most common endpoint family, present in 34 of 56 trials (60.7%). Biomarker measurement is the second major pillar: blood or cerebrospinal-fluid (CSF) biomarkers appear in 23 trials (41.1%), tau-related pathology in 10 trials (17.9%), and amyloid PET / amyloid burden in 8 trials (14.3%).
| Endpoint family | Trials | Share |
|---|---|---|
| Safety / tolerability | 34/56 | 60.7% |
| Blood / CSF biomarkers | 23/56 | 41.1% |
| CDR / CDR-SB | 17/56 | 30.4% |
| MRI / structural neuroimaging | 15/56 | 26.8% |
| ADAS-Cog | 14/56 | 25.0% |
| NPI-C / neuropsychiatric symptoms | 13/56 | 23.2% |
| MMSE | 13/56 | 23.2% |
| ADCS-ADL / iADL | 13/56 | 23.2% |
European Alzheimer’s CTIS submissions are not built around a single dominant cognitive scale. They combine safety, fluid biomarkers, clinical staging, imaging, and function, reflecting the split between disease-modifying trials and symptom-management trials.
The dataset contains 280 endpoint entries: 79 primary endpoints, 198 secondary endpoints, and 3 other/exploratory endpoints. Primary endpoints are most often safety-led, with safety / tolerability appearing as a primary endpoint family in 18 of 56 trials (32.1%). Secondary endpoints carry most biomarker and functional breadth: blood / CSF biomarkers appear as secondary endpoints in 23 trials (41.1%), and ADCS-ADL / iADL appears in 13 trials (23.2%).
Primary endpoints are concentrated around safety and a smaller set of pivotal clinical or imaging measures, while secondary endpoints carry the broader disease-biology package. Other/exploratory endpoint fields are rare, appearing in only 2 of 56 trials (3.6%) and accounting for 3 endpoint entries.
Phase II trials account for 28 of 56 trials (50.0%), Phase III for 23 trials (41.1%), and Phase II/III for 5 trials (8.9%). Phase II is more biomarker-intensive: blood / CSF biomarkers appear in 16 of 28 Phase II trials (57.1%) versus 3 of 23 Phase III trials (13.0%). Phase III places more relative emphasis on symptom and global scales, including CGI measures in 6 of 23 trials (26.1%).
| Endpoint family | Phase II n=28 |
Phase II/III n=5 |
Phase III n=23 |
|---|---|---|---|
| Safety / tolerability | 20/28 · 71.4% | 4/5 · 80.0% | 10/23 · 43.5% |
| Blood / CSF biomarkers | 16/28 · 57.1% | 4/5 · 80.0% | 3/23 · 13.0% |
| CDR / CDR-SB | 9/28 · 32.1% | 3/5 · 60.0% | 5/ |