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.
2 other identifiers
interventional
611
14 countries
95
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 alzheimer-disease
Started Aug 2016
Typical duration for phase_2 alzheimer-disease
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 2, 2016
CompletedStudy Start
First participant enrolled
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2019
CompletedResults Posted
Study results publicly available
November 6, 2020
CompletedNovember 6, 2020
October 1, 2020
3.1 years
May 27, 2016
September 10, 2020
October 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 Item (ADAS-Cog11) Total Score After 12 Weeks of Treatment
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.
On day 1 (visit 2, baseline) and day 85 (end of trial)
Secondary Outcomes (2)
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)
Study Arms (5)
BI 425809 dose 1
EXPERIMENTALBI 425809 dose 2
EXPERIMENTALBI 425809 dose 3
EXPERIMENTALBI 425809 dose 4
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
Axiom Research LLC
Colton, California, 92324, United States
Alliance for Wellness
Long Beach, California, 90807, United States
Anderson Clinical Research
Redlands, California, 92374, United States
CITrials
Santa Ana, California, 92705, United States
MD Clinical
Hallandale, Florida, 33009, United States
Galiz Research
Miami, Florida, 33016, United States
Premier Clinical Research Institute
Miami, Florida, 33122, United States
Miami Jewish Health System
Miami, Florida, 33137, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Bioclinica Research
The Villages, Florida, 32162, United States
Neuro Trials Research Incorporated
Atlanta, Georgia, 30342, United States
Millennium Psychiatric Associates LLC
St Louis, Missouri, 63132, United States
ANI Neurology, PLLC, dba Alzheimer's Memory Center
Charlotte, North Carolina, 28270, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104, United States
Northeastern Pennsylvania Memory and Alzheimer Center
Plains, Pennsylvania, 18705, United States
Roper St. Francis Healthcare
Charleston, South Carolina, 29401, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
LKH-Univ. Hospital Graz
Graz, 8036, Austria
Medical University of Innsbruck
Innsbruck, 6020, Austria
SALK Christian-Doppler-Klinik,Paracel.Med.Privatuni.f.Neurol
Salzburg, 5020, Austria
Private Practice for Psychiatry and Neurology
Vienna, 1130, Austria
The Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 4N7, Canada
True North Clinical Research Halifax, Inc.
Halifax, Nova Scotia, B3S 1M7, Canada
True North Clinical Research Kentville, Inc.
Kentville, Nova Scotia, B4N 4K9, Canada
Bluewater Clinical Research
Sarnia, Ontario, N7T 4X3, Canada
Clinique Neuro-Outaouais
Gatineau, Quebec, J8Y 1W2, Canada
Diex Recherche
Sherbrooke, Quebec, J1H 0H8, Canada
Orton
Helsinki, FI-00280, Finland
University of Eastern Finland, Brain Research Unit
Kuopio, 70210, Finland
Terveystalo Lahti
Lahti, 15110, Finland
OYS, Neurologian tutkimusyksikkö
Oulu, 90220, Finland
CRST - Clinical Research Services Turku
Turku, 20520, Finland
HOP Pellegrin
Bordeaux, 33076, France
HOP Pierre Wertheimer
Bron, 69677, France
HOP Roger Salengro
Lille, 59037, France
HOP Gui de Chauliac
Montpellier, 34295, France
HOP Nord Laënnec
Nantes, 44093, France
HOP La Pitié Salpêtrière
Paris, 75651, France
CHU La Grave-Casselardit - Cité de la Santé
Toulouse, 31052, France
HOP Brabois
Vandœuvre-lès-Nancy, 54500, France
HOP des Charpennes
Villeurbanne, 69100, France
Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen
Bad Homburg, 61348, Germany
Praxis Dr. med. Volker Schumann
Berlin, 10245, Germany
Charité - Universitätsmedizin Berlin
Berlin, 12200, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13125, Germany
Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
Praxis Dr. Oehlwein
Gera, 07551, Germany
Pharmakologisches Studienzentrum Chemnitz
Mittweida, 09648, Germany
Institut für Psychogerontologie
Nuremberg, 90408, Germany
Neuropraxis München Süd, Unterhaching
Unterhaching, 82008, Germany
Naval Hospital of Athens
Athens, 11521, Greece
Eginition Hospital
Athens, 11528, Greece
University General Hospital Attikon
Athens, 124 62, Greece
Athens Medical Center
Athens, 15125, Greece
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54621, Greece
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54636, Greece
Semmelweis University
Budapest, 1083, Hungary
CRU Ltd, Neurology Dept., Miskolc
Miskolc, 3526, Hungary
University of Szeged
Szeged, 6725, Hungary
IRCCS Fondazione Ospedale Maggiore
Milan, 20122, Italy
A.O. San Gerardo di Monza
Monza (MB), 20900, Italy
Azienda Ospedaliera Universitaria di Padova
Padua, 35128, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126, Italy
Fujita Health University Hospital
Aichi, Toyoake, 470-1192, Japan
Inage Neurology and Memory Clinic
Chiba, Chiba, 263-0043, Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543, Japan
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793, Japan
Kawashima Neurology Clinic
Kanagawa, Fujisawa, 251-0038, Japan
Ishikawa Clinic
Kyoto, Kyoto, 606-0851, Japan
Nara Medical University Hospital
Nara, Kashihara, 634-8522, Japan
Katayama Medical Clinic
Okayama, Kurashiki, 710-0813, Japan
National Hospital Organization Hizen Psychiatric Center
Saga, Kanzaki-gun, 842-0192, Japan
National Center Neurology and Psychiatry
Tokyo, Kodaira, 187-8551, Japan
Nozomi Memory Clinic
Tokyo, Mitaka, 181-0013, Japan
Showa University East Hospital
Tokyo, Shinagawa, 142-0054, Japan
Oslo Universitetssykehus HF, Hukommelsesklinikken
Oslo, N-0450, Norway
St. Olavs Hospital, Universitetssykehuset i Trondheim
Trondheim, N-7030, Norway
Podlassian Center of Psychogeriatry, Bialystok
Bialystok, 15-732, Poland
Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o
Bydgoszcz, 85-023, Poland
Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
Poznan, 61-853, Poland
EUROMEDIS Sp. z o.o., Szczecin
Szczecin, 70-111, Poland
Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
Torun, 87-100, Poland
Hospital del Mar
Barcelona, 08003, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Sant Joan de Deu de Manresa
Manresa, 08423, Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, 08190, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Viamed Montecanal
Zaragoza, 50012, Spain
Royal Cornhill Hospital
Aberdeen, AB25 2ZH, United Kingdom
Fulbourn Hospital
Cambridge, CB21 5EF, United Kingdom
Ninewells Hospital & Medical School
Dundee, DD2 1SY, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Warneford Hospital
Oxford, OX3 7JX, United Kingdom
Sheffield Memory Service
Sheffield, S10 3TH, United Kingdom
Related Publications (1)
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.
PMID: 36709275DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2016
First Posted
June 2, 2016
Study Start
August 11, 2016
Primary Completion
September 12, 2019
Study Completion
October 11, 2019
Last Updated
November 6, 2020
Results First Posted
November 6, 2020
Record last verified: 2020-10