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NCT02788513 · ClinicalTrials.gov registry record · Phase 2
BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
A Phase 2 study of Alzheimer Disease, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 611
- Enrollment target
- 20
- Study locations
NCT02788513: Completed Phase 2 study of Alzheimer Disease, sponsored by Boehringer Ingelheim.
NCT02788513 is a Phase 2 study of Alzheimer Disease that has completed, run by Boehringer Ingelheim. The registered enrollment target is 611 participants, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02788513, a Phase 2 study of Alzheimer Disease, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 611 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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, basel
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BI 425809 dose 1
- DRUG BI 425809 dose 2
- DRUG BI 425809 dose 3
- DRUG BI 425809 dose 4
Study Locations (20)
Florida
- MD Clinical - Hallandale
- Galiz Research - Miami
- Premier Clinical Research Institute - Miami
- Miami Jewish Health System - Miami
- Stedman Clinical Trials - Tampa
- Bioclinica Research - The Villages
California
- Axiom Research LLC - Colton
- Alliance for Wellness - Long Beach
- Anderson Clinical Research - Redlands
- CITrials - Santa Ana
Other
- LKH-Univ. Hospital Graz - Graz
- Medical University of Innsbruck - Innsbruck
- SALK Christian-Doppler-Klinik,Paracel.Med.Privatuni.f.Neurol - Salzburg
Georgia
- Neuro Trials Research Incorporated - Atlanta
Missouri
- Millennium Psychiatric Associates LLC - St Louis
North Carolina
- ANI Neurology, PLLC, dba Alzheimer's Memory Center - Charlotte
Oklahoma
- Tulsa Clinical Research, LLC - Tulsa
Pennsylvania
- Northeastern Pennsylvania Memory and Alzheimer Center - Plains
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 611 participants |
| Start Date | 2016-08-11 |
| Est. Completion | 2019-10-11 |
| Phase | Phase 2 |
What the finished NCT02788513 record still lists
NCT02788513 is an interventional study that assigns participants to a tested intervention. The registered 611 participants enrollment target is mid-sized for trials with a published cap, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT02788513 names 20 study sites across 10 states, led by Florida, California, Other.
Frequently Asked Questions
What is clinical trial NCT02788513 about?
NCT02788513 is a clinical study titled "BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.". The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.
What is the current status of trial NCT02788513?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 611 participants. The study started on 2016-08-11. Estimated completion is 2019-10-11.
What conditions does trial NCT02788513 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT02788513?
The interventions under investigation include: Placebo (DRUG), BI 425809 dose 1 (DRUG), BI 425809 dose 2 (DRUG), BI 425809 dose 3 (DRUG), BI 425809 dose 4 (DRUG).
Who is sponsoring clinical trial NCT02788513?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02788513 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02788513's enrollment target sits among peer trials
611 45th of 306 higher than 262 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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