At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 611 enrolled
Drug / intervention
BI 425809 dose 1 +4 moredrug
Likely dose
Not stated in record
Key inclusion· 6
- ✓Age at least 55 years
- ✓Early signs of dementia of Alzheimer Type
- ✓Acetylcholinesterase inhibitors (AChEIs) allowed if stable dose ≥3 months prior to screening, with no planned changes
- ✓Patients not on AChEIs eligible if stopped ≥3 months prior to screening
Key exclusion· 6
- ✕Cognitive impairment or dementia with etiology other than Alzheimer's Dementia
- ✕Substantial concomitant cerebrovascular disease with history of stroke or intracranial hemorrhage temporally related to onset of cognitive impairment decline
- ✕Symptomatic and unstable/uncontrolled medical conditions
- ✕Prescribed dementia drugs other than AChEIs at screening or within 3 months prior to screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating BI 425809 dose 1, BI 425809 dose 2, and 3 other interventions for Alzheimer Disease. Completed, enrolled 611 participants across 95 sites in 14 countries.
Detailed 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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesAustria, Canada, Finland, France, Germany, Greece, Hungary, Italy, Japan, Norway, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartAug 2016
Primary CompletionSep 2019
Study CompletionOct 2019
TodayJul 2026
First PostedJun 2, 2016
Enrollment StartAug 11, 2016
Primary CompletionSep 12, 2019
Study CompletionOct 11, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.1 years ago
Interventions
BI 425809 dose 1drug
BI 425809 dose 2drug
BI 425809 dose 3drug
BI 425809 dose 4drug
Placebodrug