Mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia.
Conditions
Brief summary
Core - Change from baseline in the CDR-SB at 18 months., Extension - Incidence of AEs and changes in vital signs, ECGs, laboratory safety tests, suicidality assessments, ADAs, and MRI safety parameters. - Change from Core Study baseline in CDR-SB
Detailed description
The key secondary endpoints for this study are: - Change from baseline in amyloid PET using Centiloids at 18 months for brain amyloid levels - Change from baseline in ADAS-cog14 at 18 months - Change from baseline in ADCOMS at 18 months - Change from baseline in ADCS MCI-ADL at 18 months., OTHER SECONDARY ENDPOINTS: Refer to protocol., BM Endpoints: Refer to protocol.
Interventions
DRUGLecanemab
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Core - Change from baseline in the CDR-SB at 18 months., Extension - Incidence of AEs and changes in vital signs, ECGs, laboratory safety tests, suicidality assessments, ADAs, and MRI safety parameters. - Change from Core Study baseline in CDR-SB | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoints for this study are: - Change from baseline in amyloid PET using Centiloids at 18 months for brain amyloid levels - Change from baseline in ADAS-cog14 at 18 months - Change from baseline in ADCOMS at 18 months - Change from baseline in ADCS MCI-ADL at 18 months., OTHER SECONDARY ENDPOINTS: Refer to protocol., BM Endpoints: Refer to protocol. | — |
Countries
France, Germany, Italy, Spain, Sweden
Outcome results
None listed