BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Phase 2

Completed

Conditions: Alzheimer Disease

Interventions: Drug: BI 425809 dose 1
Drug: BI 425809 dose 2
Drug: BI 425809 dose 3
Drug: BI 425809 dose 4
Drug: Placebo

Registration Number: NCT02788513

Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 611

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 425809 dose 1	BI 425809 dose 1	-
BI 425809 dose 1	Placebo	-
BI 425809 dose 2	BI 425809 dose 2	-
BI 425809 dose 2	Placebo	-
BI 425809 dose 3	BI 425809 dose 3	-
BI 425809 dose 3	Placebo	-
BI 425809 dose 4	BI 425809 dose 4	-
BI 425809 dose 4	Placebo	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 Item (ADAS-Cog11) Total Score After 12 Weeks of Treatment	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 Outcome Measures

Name	Time	Method
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)	Change from baseline in the ADCS-ADL score after 12 weeks of treatment is presented. The ADCS-ADL is a rating scale used to assess basic and instrumental activities of daily living. In the full version of the scale, 23 items are rated by the investigator using information supplied by the caregiver. Each item has a score range varying from 0-3 to 0-5. The sum score could range from 0 to 78, with higher scores indicating less severe impairment. A positive change indicates an improvement from baseline. Abbreviation: MMSE = Mini Mental State Examination
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)	Clinician's Interview-Based Impression of Change (CIBIC+) score is based on semi-structured interview covering domains of function and cognition. It additionally requires the assessment of psychiatric signs and symptoms. The patient and their caregiver are interviewed and questioned by the clinician. Change rate is based on an unanchored 7-point scale (with 0 being not assessed, 1-3 being very much improved to minimally improved, 4 being no change, and 5-7 being minimally worse to very much worse). For the ANCOVA model, the baseline value for CIBIC+ is represented by CIBIS which is clinician's interview-based impression of severity score (scores range from 0-7, with 0 being not assessed, 1 being normal, and 7 being most extremely ill) in order to adjust for potential baseline heterogeneity. Abbreviation: MMSE = Mini Mental State Examination

Trial Locations

Locations (93): Axiom Research LLC
🇺🇸
Colton, California, United States
Alliance for Wellness
🇺🇸
Long Beach, California, United States
Anderson Clinical Research
🇺🇸
Redlands, California, United States
CITrials
🇺🇸
Santa Ana, California, United States
MD Clinical
🇺🇸
Hallandale Beach, Florida, United States
Galiz Research
🇺🇸
Miami, Florida, United States
Premier Clinical Research Institute
🇺🇸
Miami, Florida, United States
Miami Jewish Health System
🇺🇸
Miami, Florida, United States
Stedman Clinical Trials
🇺🇸
Tampa, Florida, United States
Bioclinica Research
🇺🇸
The Villages, Florida, United States
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Axiom Research LLC
🇺🇸Colton, California, United States