A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy and Safety of Orally Administered BI 425809 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer's Disease.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 611
- Locations
- 93
- Primary Endpoint
- Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 Item (ADAS-Cog11) Total Score After 12 Weeks of Treatment
Study Overview
Brief Summary
The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 425809 dose 1
Intervention: BI 425809 dose 1 (Drug)
BI 425809 dose 1
Intervention: Placebo (Drug)
BI 425809 dose 2
Intervention: BI 425809 dose 2 (Drug)
BI 425809 dose 2
Intervention: Placebo (Drug)
BI 425809 dose 3
Intervention: BI 425809 dose 3 (Drug)
BI 425809 dose 3
Intervention: Placebo (Drug)
BI 425809 dose 4
Intervention: BI 425809 dose 4 (Drug)
BI 425809 dose 4
Intervention: Placebo (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 Item (ADAS-Cog11) Total Score After 12 Weeks of Treatment
Time Frame: On day 1 (visit 2, baseline) and day 85 (end of trial)
The ADAS-Cog11 is an 11-item cognitive subscale that objectively measures memory, language, orientation and praxis with a total score range of 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline. Multiple comparison procedures and modelling (MCPmod) in combination with mixed model repeated measures (MMRM) is used for primary analysis of the primary endpoint. MMRM included fixed, categorical covariates of treatment, visit, baseline Mini Mental State Examination MMSE (\>=20, \<20) and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. Patient was considered as random effect. The unstructured covariance structure was used to model the within patient measurements. The same MMRM model used in the primary analysis is used for the secondary analysis of the primary endpoint.
Secondary Outcomes
- Change From Baseline in the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Score After 12 Weeks of Treatment(On day 1 (visit 2, baseline) and day 85 (end of trial))
- Clinician's Interview-Based Impression of Change (CIBIC+) Score After 12 Weeks of Treatment(On day 1 (visit 2, baseline) and day 85 (end of trial))
