CompletedPhase 2Results posted

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

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.

Lead sponsor

Boehringer Ingelheim

Asset

BI 425809

Listed sites

Recruiting sites

Enrollment

611

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Study partner/caregiver required•AD symptomatic therapy: stable ≥3 months

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID1346.23

Eudract number2015-005438-24

NCT IDNCT02788513

Timeline

Milestones

Study first posted2016-06-02estimated

Study start2016-08-11actual

Primary completion2019-09-12actual

Study completion2019-10-11actual

Last update posted2020-11-06actual

Results first posted2020-11-06actual

Assets

Drug assets

BI 425809

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with early signs of dementia of Alzheimer Type

•Male and female patients with an age of at least 55 years

•Concomitant use of acetylcholinesterase inhibitors (AChEIs) is allowed but not required. Patients who are currently taking AChEIs are eligible as long as they have been using a stable dose for at least 3 months prior to screening and no change is foreseen for the duration of the study. This dose must be consistent with the product label in the concerned country. Patients who are not currently taking AChEIs but have taken them in the past are also eligible if AChEIs were stopped at least 3 months prior to screening.

•Patients must have at least 6 years of formal education and fluency in the test language as verbally confirmed by the patient and documented by the study investigator.

•Patients must have a reliable study partner (per investigator judgement, for instance a family member, partner etc., guardian)

•Further inclusion criteria apply

Exclusion criteria

•Cognitive impairment or dementia with any etiology other than Alzheimer's Dementia (AD)

•Substantial concomitant cerebrovascular disease (defined by a history of a stroke / intracranial haemorrhagia) temporally related to the onset of worsening of cognitive impairment per investigator judgement

•Medical history or diagnosis of any of symptomatic and unstable/uncontrolled conditions per investigator judgement

•Patients receiving prescribed drugs for treatment of dementia of Alzheimer Type (other than Acetylcholine Esterase Inhibitors) at screening or within 3 months prior to screening

•Previous participation in investigational drug studies of dementia of Alzheimer's Type within three months prior to screening. Patients having received any active treatment in studies targeting disease modification of AD are excluded. Previous participation in studies with non-prescription medications, vitamins or other nutritional formulations is allowed.

•Clinically significant uncompensated hearing loss in the judgment of the investigator. Use of hearing aids is allowed.

•Further exclusion criteria apply

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

6 endpoints

Primary/protocol endpoint

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)

ADAS-Cog

change from baseline, improvement

Primary/registry result

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)

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
2 mg BI 425809n=121 Participants	0.026	4.864
5 mg BI 425809n=120 Participants	0.175	4.471
10 mg BI 425809n=121 Participants	0.699	4.313
25 mg BI 425809n=119 Participants	-0.174	4.044
Placebo Groupn=118 Participants	0.138	4.939

p0.9931MCPMod Beta model fit.

Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.

p0.9225MCPMod Emax model fit.

Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.

p0.9287MCPMod Sigmoidal Emax model fit.

Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.

p0.7646MCPMod linear model fit.

Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.

p0.9335MCPMod linear in log model fit.

Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.

p0.8199MCPMod logistic model fit.

Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.

Mean Difference (Final Values)0.0595% CI-1.09 - 1.18p0.9340MMRM

Mixed model repeated measures (MMRM)

Median Difference (Final Values)0.3095% CI-0.84 - 1.44p0.6041MMRM

Mixed model repeated measures (MMRM)

Mean Difference (Final Values)0.7695% CI-0.38 - 1.90p0.1926MMRM

Mixed model repeated measures (MMRM)

Median Difference (Final Values)-0.0295% CI-1.16 - 1.12p0.9739MMRM

Mixed model repeated measures (MMRM)

Secondary/protocol endpoint

Change From Baseline in the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Score After 12 Weeks of Treatment

Time frame:On day 1 (visit 2, baseline) and day 85 (end of trial)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Clinician's Interview-Based Impression of Change (CIBIC+) Score After 12 Weeks of Treatment

Time frame:On day 1 (visit 2, baseline) and day 85 (end of trial)

Mini-Mental State Examination (MMSE)

descriptive

Secondary/registry result

Change From Baseline in the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Score After 12 Weeks of Treatment

Time frame:On day 1 (visit 2, baseline) and day 85 (end of trial)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
2 mg BI 425809n=113 Participants	0.283	6.805
5 mg BI 425809n=111 Participants	0.577	5.852
10 mg BI 425809n=110 Participants	-1.145	4.764
25 mg BI 425809n=116 Participants	-1.828	7.034
Placebo Groupn=111 Participants	0.261	4.842

Mean Difference (Final Values)0.0295% CI-1.48 - 1.52p0.979ANCOVA

Analysis of Covariance (ANCOVA)

Mean Difference (Final Values)0.4995% CI-1.01 - 2.00p0.521ANCOVA

Analysis of Covariance (ANCOVA)

Mean Difference (Final Values)-1.5395% CI-3.04 - -0.02p0.047ANCOVA

Analysis of Covariance (ANCOVA)

Mean Difference (Final Values)-2.1695% CI-3.65 - -0.67p0.005ANCOVA

Analysis of Covariance (ANCOVA)

Secondary/registry result

Clinician's Interview-Based Impression of Change (CIBIC+) Score After 12 Weeks of Treatment

Time frame:On day 1 (visit 2, baseline) and day 85 (end of trial)

Mini-Mental State Examination (MMSE)

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
2 mg BI 425809n=114 Participants	4.000	0.941
5 mg BI 425809n=112 Participants	4.080	0.773
10 mg BI 425809n=110 Participants	4.209	0.679
25 mg BI 425809n=116 Participants	4.224	0.781
Placebo Groupn=112 Participants	4.080	0.829

Mean Difference (Final Values)-0.1095% CI-0.32 - 0.11p0.343ANCOVA

Analysis of Covariance (ANCOVA)

Mean Difference (Final Values)-0.0595% CI-0.26 - 0.16p0.645ANCOVA

Analysis of Covariance (ANCOVA)

Mean Difference (Final Values)0.0895% CI-0.13 - 0.30p0.448ANCOVA

Analysis of Covariance (ANCOVA)

Mean Difference (Final Values)0.1095% CI-0.11 - 0.32p0.340ANCOVA

Analysis of Covariance (ANCOVA)

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Wunderlich G, Blahova Z, Garcia M, Jessen F. Efficacy and safety of the novel GlyT1 inhibitor BI 425809 in Alzheimer's dementia: a randomized controlled trial. Alzheimers Res Ther. 2023 Jan 28;15(1):24. doi: 10.1186/s13195-023-01163-3.
PMID36709275via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.