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Clinical Trials/NCT02788513
NCT02788513CompletedPhase 2

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.

Boehringer Ingelheim93 sites in 7 countries611 target enrollmentStarted: August 11, 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
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

Experimental

Intervention: BI 425809 dose 1 (Drug)

BI 425809 dose 1

Experimental

Intervention: Placebo (Drug)

BI 425809 dose 2

Experimental

Intervention: BI 425809 dose 2 (Drug)

BI 425809 dose 2

Experimental

Intervention: Placebo (Drug)

BI 425809 dose 3

Experimental

Intervention: BI 425809 dose 3 (Drug)

BI 425809 dose 3

Experimental

Intervention: Placebo (Drug)

BI 425809 dose 4

Experimental

Intervention: BI 425809 dose 4 (Drug)

BI 425809 dose 4

Experimental

Intervention: Placebo (Drug)

Placebo

Placebo Comparator

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))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (93)

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