Clinical trial NCT02788513: BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-06-02
Enrollment: 611
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 Item (ADAS-Cog11) Total Score After 12 Weeks of Treatment
timeFrame: On day 1 (visit 2, baseline) and day 85 (end of trial)
Secondary outcomes:
measure: Change From Baseline in the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Score After 12 Weeks of Treatment
timeFrame: On day 1 (visit 2, baseline) and day 85 (end of trial)
measure: Clinician's Interview-Based Impression of Change (CIBIC+) Score After 12 Weeks of Treatment
timeFrame: On day 1 (visit 2, baseline) and day 85 (end of trial)
Other outcomes:
Locations:
city: Colton
country: United States
facility: Axiom Research LLC
state: California
city: Long Beach
country: United States
facility: Alliance for Wellness
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Santa Ana
country: United States
facility: CITrials
state: California
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Miami
country: United States
facility: Galiz Research
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health System
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: The Villages
country: United States
facility: Bioclinica Research
state: Florida
city: Atlanta
country: United States
facility: Neuro Trials Research Incorporated
state: Georgia
city: Saint Louis
country: United States
facility: Millennium Psychiatric Associates LLC
state: Missouri
city: Charlotte
country: United States
facility: ANI Neurology, PLLC, dba Alzheimer's Memory Center
state: North Carolina
city: Tulsa
country: United States
facility: Tulsa Clinical Research, LLC
state: Oklahoma
city: Plains
country: United States
facility: Northeastern Pennsylvania Memory and Alzheimer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Roper St. Francis Healthcare
state: South Carolina
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Graz
country: Austria
facility: LKH-Univ. Hospital Graz
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Salzburg
country: Austria
facility: SALK Christian-Doppler-Klinik,Paracel.Med.Privatuni.f.Neurol
city: Vienna
country: Austria
facility: Private Practice for Psychiatry and Neurology
city: Kelowna
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Halifax
country: Canada
facility: True North Clinical Research Halifax, Inc.
state: Nova Scotia
city: Kentville
country: Canada
facility: True North Clinical Research Kentville, Inc.
state: Nova Scotia
city: Sarnia
country: Canada
facility: Bluewater Clinical Research
state: Ontario
city: Gatineau
country: Canada
facility: Clinique Neuro-Outaouais
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche
state: Quebec
city: Helsinki
country: Finland
facility: Orton
city: Kuopio
country: Finland
facility: University of Eastern Finland, Brain Research Unit
city: Lahti
country: Finland
facility: Terveystalo Lahti
city: Oulu
country: Finland
facility: OYS, Neurologian tutkimusyksikkö
city: Turku
country: Finland
facility: CRST - Clinical Research Services Turku
city: Bordeaux
country: France
facility: HOP Pellegrin
city: Bron
country: France
facility: HOP Pierre Wertheimer
city: Lille
country: France
facility: HOP Roger Salengro
city: Montpellier
country: France
facility: HOP Gui de Chauliac
city: Nantes
country: France
facility: HOP Nord Laënnec
city: Paris
country: France
facility: HOP La Pitié Salpêtrière
city: Toulouse
country: France
facility: CHU La Grave-Casselardit - Cité de la Santé
city: Vandoeuvre les Nancy
country: France
facility: HOP Brabois
city: Villeurbanne
country: France
facility: HOP des Charpennes
city: Bad Homburg
country: Germany
facility: Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen
city: Berlin
country: Germany
facility: Praxis Dr. med. Volker Schumann
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Gera
country: Germany
facility: Praxis Dr. Oehlwein
city: Köln
country: Germany
facility: Universitätsklinikum Köln (AöR)
city: Mittweida
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz
city: Nürnberg
country: Germany
facility: Institut für Psychogerontologie
city: Unterhaching
country: Germany
facility: Neuropraxis München Süd, Unterhaching
city: Athens
country: Greece
facility: Naval Hospital of Athens
city: Athens
country: Greece
facility: Eginition Hospital
city: Athens
country: Greece
facility: University General Hospital Attikon
city: Athens
country: Greece
facility: Athens Medical Center
city: Thessaloniki
country: Greece
facility: University General Hospital of Thessaloniki AHEPA
city: Thessaloniki
country: Greece
facility: University General Hospital of Thessaloniki AHEPA
city: Budapest
country: Hungary
facility: Semmelweis University
city: Miskolc
country: Hungary
facility: CRU Ltd, Neurology Dept., Miskolc
city: Szeged
country: Hungary
facility: University of Szeged
city: Milano
country: Italy
facility: IRCCS Fondazione Ospedale Maggiore
city: Monza (MB)
country: Italy
facility: A.O. San Gerardo di Monza
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Aichi, Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Chiba, Chiba
country: Japan
facility: Inage Neurology and Memory Clinic
city: Hokkaido, Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Kagawa, Kita-gun
country: Japan
facility: Kagawa University Hospital
city: Kanagawa, Fujisawa
country: Japan
facility: Kawashima Neurology Clinic
city: Kyoto, Kyoto
country: Japan
facility: Ishikawa Clinic
city: Nara, Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Okayama, Kurashiki
country: Japan
facility: Katayama Medical Clinic
city: Saga, Kanzaki-gun
country: Japan
facility: National Hospital Organization Hizen Psychiatric Center
city: Tokyo, Kodaira
country: Japan
facility: National Center Neurology and Psychiatry
city: Tokyo, Mitaka
country: Japan
facility: Nozomi Memory Clinic
city: Tokyo, Shinagawa
country: Japan
facility: Showa University East Hospital
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Hukommelsesklinikken
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Universitetssykehuset i Trondheim
city: Bialystok
country: Poland
facility: Podlassian Center of Psychogeriatry, Bialystok
city: Bydgoszcz
country: Poland
facility: Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o
city: Poznan
country: Poland
facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
city: Szczecin
country: Poland
facility: EUROMEDIS Sp. z o.o., Szczecin
city: Torun
country: Poland
facility: Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Manresa
country: Spain
facility: Hospital Sant Joan de Deu de Manresa
city: Sant Cugat del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Zaragoza
country: Spain
facility: Hospital Viamed Montecanal
city: Aberdeen
country: United Kingdom
facility: Royal Cornhill Hospital
city: Cambridge
country: United Kingdom
facility: Fulbourn Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Oxford
country: United Kingdom
facility: Warneford Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Memory Service
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: