BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
NCT ID: NCT02788513
Last Updated: 2020-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
611 participants
INTERVENTIONAL
2016-08-11
2019-10-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BI 425809 dose 1
BI 425809 dose 1
Placebo
BI 425809 dose 2
BI 425809 dose 2
Placebo
BI 425809 dose 3
BI 425809 dose 3
Placebo
BI 425809 dose 4
BI 425809 dose 4
Placebo
Placebo
Placebo
Interventions
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BI 425809 dose 1
BI 425809 dose 2
BI 425809 dose 3
BI 425809 dose 4
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
55 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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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, 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
Neuro Trials Research Incorporated
Atlanta, Georgia, United States
Millennium Psychiatric Associates LLC
St Louis, Missouri, United States
ANI Neurology, PLLC, dba Alzheimer's Memory Center
Charlotte, North Carolina, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States
Northeastern Pennsylvania Memory and Alzheimer Center
Plains, Pennsylvania, United States
Roper St. Francis Healthcare
Charleston, South Carolina, United States
The Memory Clinic
Bennington, Vermont, United States
LKH-Univ. Hospital Graz
Graz, , Austria
Medical University of Innsbruck
Innsbruck, , Austria
SALK Christian-Doppler-Klinik,Paracel.Med.Privatuni.f.Neurol
Salzburg, , Austria
Private Practice for Psychiatry and Neurology
Vienna, , Austria
The Medical Arts Health Research Group
Kelowna, British Columbia, Canada
True North Clinical Research Halifax, Inc.
Halifax, Nova Scotia, Canada
True North Clinical Research Kentville, Inc.
Kentville, Nova Scotia, Canada
Bluewater Clinical Research
Sarnia, Ontario, Canada
Clinique Neuro-Outaouais
Gatineau, Quebec, Canada
Diex Recherche
Sherbrooke, Quebec, Canada
Orton
Helsinki, , Finland
University of Eastern Finland, Brain Research Unit
Kuopio, , Finland
Terveystalo Lahti
Lahti, , Finland
OYS, Neurologian tutkimusyksikkö
Oulu, , Finland
CRST - Clinical Research Services Turku
Turku, , Finland
HOP Pellegrin
Bordeaux, , France
HOP Pierre Wertheimer
Bron, , France
HOP Roger Salengro
Lille, , France
HOP Gui de Chauliac
Montpellier, , France
HOP Nord Laënnec
Nantes, , France
HOP La Pitié Salpêtrière
Paris, , France
CHU La Grave-Casselardit - Cité de la Santé
Toulouse, , France
HOP Brabois
Vandœuvre-lès-Nancy, , France
HOP des Charpennes
Villeurbanne, , France
Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen
Bad Homburg, , Germany
Praxis Dr. med. Volker Schumann
Berlin, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Köln (AöR)
Cologne, , Germany
Praxis Dr. Oehlwein
Gera, , Germany
Pharmakologisches Studienzentrum Chemnitz
Mittweida, , Germany
Institut für Psychogerontologie
Nuremberg, , Germany
Neuropraxis München Süd, Unterhaching
Unterhaching, , Germany
Naval Hospital of Athens
Athens, , Greece
Eginition Hospital
Athens, , Greece
University General Hospital Attikon
Athens, , Greece
Athens Medical Center
Athens, , Greece
University General Hospital of Thessaloniki AHEPA
Thessaloniki, , Greece
University General Hospital of Thessaloniki AHEPA
Thessaloniki, , Greece
Semmelweis University
Budapest, , Hungary
CRU Ltd, Neurology Dept., Miskolc
Miskolc, , Hungary
University of Szeged
Szeged, , Hungary
IRCCS Fondazione Ospedale Maggiore
Milan, , Italy
A.O. San Gerardo di Monza
Monza (MB), , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Fujita Health University Hospital
Aichi, Toyoake, , Japan
Inage Neurology and Memory Clinic
Chiba, Chiba, , Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, , Japan
Kagawa University Hospital
Kagawa, Kita-gun, , Japan
Kawashima Neurology Clinic
Kanagawa, Fujisawa, , Japan
Ishikawa Clinic
Kyoto, Kyoto, , Japan
Nara Medical University Hospital
Nara, Kashihara, , Japan
Katayama Medical Clinic
Okayama, Kurashiki, , Japan
National Hospital Organization Hizen Psychiatric Center
Saga, Kanzaki-gun, , Japan
National Center Neurology and Psychiatry
Tokyo, Kodaira, , Japan
Nozomi Memory Clinic
Tokyo, Mitaka, , Japan
Showa University East Hospital
Tokyo, Shinagawa, , Japan
Oslo Universitetssykehus HF, Hukommelsesklinikken
Oslo, , Norway
St. Olavs Hospital, Universitetssykehuset i Trondheim
Trondheim, , Norway
Podlassian Center of Psychogeriatry, Bialystok
Bialystok, , Poland
Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o
Bydgoszcz, , Poland
Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
Poznan, , Poland
EUROMEDIS Sp. z o.o., Szczecin
Szczecin, , Poland
Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
Torun, , Poland
Hospital del Mar
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Sant Joan de Deu de Manresa
Manresa, , Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Viamed Montecanal
Zaragoza, , Spain
Royal Cornhill Hospital
Aberdeen, , United Kingdom
Fulbourn Hospital
Cambridge, , United Kingdom
Ninewells Hospital & Medical School
Dundee, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Warneford Hospital
Oxford, , United Kingdom
Sheffield Memory Service
Sheffield, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2015-005438-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1346.23
Identifier Type: -
Identifier Source: org_study_id