BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
- Conditions
- Alzheimer Disease
- Interventions
- Drug: BI 425809 dose 1Drug: BI 425809 dose 2Drug: BI 425809 dose 3Drug: BI 425809 dose 4Drug: 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
Not provided
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 ExaminationClinician'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)
Fulbourn Hospital
🇬🇧Cambridge, United Kingdom
Diex Recherche
🇨🇦Sherbrooke, Quebec, Canada
LKH-Univ. Hospital Graz
🇦🇹Graz, Austria
Orton
🇫🇮Helsinki, Finland
Institut für Psychogerontologie
🇩🇪Nürnberg, Germany
HOP Brabois
🇫🇷Vandoeuvre les Nancy, France
Universitätsklinikum Köln (AöR)
🇩🇪Köln, Germany
Bioclinica Research
🇺🇸The Villages, Florida, United States
Galiz Research
🇺🇸Miami, Florida, United States
Premier Clinical Research Institute
🇺🇸Miami, Florida, United States
True North Clinical Research Halifax, Inc.
🇨🇦Halifax, Nova Scotia, Canada
Oslo Universitetssykehus HF, Hukommelsesklinikken
🇳🇴Oslo, Norway
Eginition Hospital
🇬🇷Athens, Greece
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
CHU La Grave-Casselardit - Cité de la Santé
🇫🇷Toulouse, France
Kagawa University Hospital
🇯🇵Kagawa, Kita-gun, Japan
Katayama Medical Clinic
🇯🇵Okayama, Kurashiki, Japan
Tulsa Clinical Research, LLC
🇺🇸Tulsa, Oklahoma, United States
HOP Pellegrin
🇫🇷Bordeaux, France
Pharmakologisches Studienzentrum Chemnitz
🇩🇪Mittweida, Germany
University of Eastern Finland, Brain Research Unit
🇫🇮Kuopio, Finland
IRCCS Fondazione Ospedale Maggiore
🇮🇹Milano, Italy
A.O. San Gerardo di Monza
🇮🇹Monza (MB), Italy
Sapporo Medical University Hospital
🇯🇵Hokkaido, Sapporo, Japan
Millennium Psychiatric Associates LLC
🇺🇸Saint Louis, Missouri, United States
Hospital Universitari General de Catalunya
🇪🇸Sant Cugat del Vallès, Spain
Hospital Viamed Montecanal
🇪🇸Zaragoza, Spain
HOP Gui de Chauliac
🇫🇷Montpellier, France
True North Clinical Research Kentville, Inc.
🇨🇦Kentville, Nova Scotia, Canada
SALK Christian-Doppler-Klinik,Paracel.Med.Privatuni.f.Neurol
🇦🇹Salzburg, Austria
The Memory Clinic
🇺🇸Bennington, Vermont, United States
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
HOP des Charpennes
🇫🇷Villeurbanne, France
Nozomi Memory Clinic
🇯🇵Tokyo, Mitaka, Japan
Praxis Dr. Oehlwein
🇩🇪Gera, Germany
HOP Nord Laënnec
🇫🇷Nantes, France
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Terveystalo Lahti
🇫🇮Lahti, Finland
Athens Medical Center
🇬🇷Athens, Greece
Azienda Ospedaliera Universitaria di Padova
🇮🇹Padova, Italy
University of Szeged
🇭🇺Szeged, Hungary
Inage Neurology and Memory Clinic
🇯🇵Chiba, Chiba, Japan
Kawashima Neurology Clinic
🇯🇵Kanagawa, Fujisawa, Japan
National Hospital Organization Hizen Psychiatric Center
🇯🇵Saga, Kanzaki-gun, Japan
HOP Pierre Wertheimer
🇫🇷Bron, France
HOP Roger Salengro
🇫🇷Lille, France
Neuropraxis München Süd, Unterhaching
🇩🇪Unterhaching, Germany
Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
🇵🇱Poznan, Poland
Nara Medical University Hospital
🇯🇵Nara, Kashihara, Japan
Hospital del Mar
🇪🇸Barcelona, Spain
Fujita Health University Hospital
🇯🇵Aichi, Toyoake, Japan
Ninewells Hospital & Medical School
🇬🇧Dundee, United Kingdom
Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
🇵🇱Torun, Poland
Hospital Sant Joan de Deu de Manresa
🇪🇸Manresa, Spain
Sheffield Memory Service
🇬🇧Sheffield, United Kingdom
Showa University East Hospital
🇯🇵Tokyo, Shinagawa, Japan
National Center Neurology and Psychiatry
🇯🇵Tokyo, Kodaira, Japan
HOP La Pitié Salpêtrière
🇫🇷Paris, France
Praxis Dr. med. Volker Schumann
🇩🇪Berlin, Germany
Axiom Research LLC
🇺🇸Colton, California, United States
Alliance for Wellness
🇺🇸Long Beach, California, United States
CITrials
🇺🇸Santa Ana, California, United States
Neuro Trials Research Incorporated
🇺🇸Atlanta, Georgia, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Bluewater Clinical Research
🇨🇦Sarnia, Ontario, Canada
Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen
🇩🇪Bad Homburg, Germany
Naval Hospital of Athens
🇬🇷Athens, Greece
University General Hospital Attikon
🇬🇷Athens, Greece
Semmelweis University
🇭🇺Budapest, Hungary
University General Hospital of Thessaloniki AHEPA
🇬🇷Thessaloniki, Greece
CRU Ltd, Neurology Dept., Miskolc
🇭🇺Miskolc, Hungary
Ishikawa Clinic
🇯🇵Kyoto, Kyoto, Japan
EUROMEDIS Sp. z o.o., Szczecin
🇵🇱Szczecin, Poland
Warneford Hospital
🇬🇧Oxford, United Kingdom
Royal Cornhill Hospital
🇬🇧Aberdeen, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
ANI Neurology, PLLC, dba Alzheimer's Memory Center
🇺🇸Charlotte, North Carolina, United States
Miami Jewish Health System
🇺🇸Miami, Florida, United States
Roper St. Francis Healthcare
🇺🇸Charleston, South Carolina, United States
Northeastern Pennsylvania Memory and Alzheimer Center
🇺🇸Plains, Pennsylvania, United States
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
The Medical Arts Health Research Group
🇨🇦Kelowna, British Columbia, Canada
Private Practice for Psychiatry and Neurology
🇦🇹Vienna, Austria
St. Olavs Hospital, Universitetssykehuset i Trondheim
🇳🇴Trondheim, Norway
Podlassian Center of Psychogeriatry, Bialystok
🇵🇱Bialystok, Poland
Medical University of Innsbruck
🇦🇹Innsbruck, Austria
OYS, Neurologian tutkimusyksikkö
🇫🇮Oulu, Finland
CRST - Clinical Research Services Turku
🇫🇮Turku, Finland
Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o
🇵🇱Bydgoszcz, Poland
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Clinique Neuro-Outaouais
🇨🇦Gatineau, Quebec, Canada