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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 425809 dose 1
BI 425809 dose 2
BI 425809 dose 3
BI 425809 dose 4
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Axiom Research LLC
  • Alliance for Wellness
  • Anderson Clinical Research
  • CITrials
  • MD Clinical
  • Galiz Research
  • Premier Clinical Research Institute
  • Miami Jewish Health System
  • Stedman Clinical Trials
  • Bioclinica Research
  • Neuro Trials Research Incorporated
  • Millennium Psychiatric Associates LLC
  • ANI Neurology, PLLC, dba Alzheimer's Memory Center
  • Tulsa Clinical Research, LLC
  • Northeastern Pennsylvania Memory and Alzheimer Center
  • Roper St. Francis Healthcare
  • The Memory Clinic
  • LKH-Univ. Hospital Graz
  • Medical University of Innsbruck
  • SALK Christian-Doppler-Klinik,Paracel.Med.Privatuni.f.Neurol
  • Private Practice for Psychiatry and Neurology
  • The Medical Arts Health Research Group
  • True North Clinical Research Halifax, Inc.
  • True North Clinical Research Kentville, Inc.
  • Bluewater Clinical Research
  • Clinique Neuro-Outaouais
  • Diex Recherche
  • Orton
  • University of Eastern Finland, Brain Research Unit
  • Terveystalo Lahti
  • OYS, Neurologian tutkimusyksikkö
  • CRST - Clinical Research Services Turku
  • HOP Pellegrin
  • HOP Pierre Wertheimer
  • HOP Roger Salengro
  • HOP Gui de Chauliac
  • HOP Nord Laënnec
  • HOP La Pitié Salpêtrière
  • CHU La Grave-Casselardit - Cité de la Santé
  • HOP Brabois
  • HOP des Charpennes
  • Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen
  • Praxis Dr. med. Volker Schumann
  • Charité - Universitätsmedizin Berlin
  • Charité - Universitätsmedizin Berlin
  • Praxis Dr. Oehlwein
  • Universitätsklinikum Köln (AöR)
  • Pharmakologisches Studienzentrum Chemnitz
  • Institut für Psychogerontologie
  • Neuropraxis München Süd, Unterhaching
  • Naval Hospital of Athens
  • Eginition Hospital
  • University General Hospital Attikon
  • Athens Medical Center
  • University General Hospital of Thessaloniki AHEPA
  • University General Hospital of Thessaloniki AHEPA
  • Semmelweis University
  • CRU Ltd, Neurology Dept., Miskolc
  • University of Szeged
  • IRCCS Fondazione Ospedale Maggiore
  • A.O. San Gerardo di Monza
  • Azienda Ospedaliera Universitaria di Padova
  • Azienda Ospedaliera Universitaria Pisana
  • Fujita Health University Hospital
  • Inage Neurology and Memory Clinic
  • Sapporo Medical University Hospital
  • Kagawa University Hospital
  • Kawashima Neurology Clinic
  • Ishikawa Clinic
  • Nara Medical University Hospital
  • Katayama Medical Clinic
  • National Hospital Organization Hizen Psychiatric Center
  • National Center Neurology and Psychiatry
  • Nozomi Memory Clinic
  • Showa University East Hospital
  • Oslo Universitetssykehus HF, Hukommelsesklinikken
  • St. Olavs Hospital, Universitetssykehuset i Trondheim
  • Podlassian Center of Psychogeriatry, Bialystok
  • Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o
  • Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
  • EUROMEDIS Sp. z o.o., Szczecin
  • Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
  • Hospital del Mar
  • Hospital Vall d'Hebron
  • Hospital Sant Joan de Deu de Manresa
  • Hospital Universitari General de Catalunya
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Viamed Montecanal
  • Royal Cornhill Hospital
  • Fulbourn Hospital
  • Ninewells Hospital & Medical School
  • Western General Hospital
  • Queen Elizabeth University Hospital
  • Warneford Hospital
  • Sheffield Memory Service

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BI 425809 dose 1

BI 425809 dose 2

BI 425809 dose 3

BI 425809 dose 4

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Score After 12 Weeks of Treatment
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 Examination
Clinician's Interview-Based Impression of Change (CIBIC+) Score After 12 Weeks of Treatment
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

Full Information

First Posted
May 27, 2016
Last Updated
October 16, 2020
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02788513
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 11, 2016 (Actual)
Primary Completion Date
September 12, 2019 (Actual)
Study Completion Date
October 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
611 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 425809 dose 1
Arm Type
Experimental
Arm Title
BI 425809 dose 2
Arm Type
Experimental
Arm Title
BI 425809 dose 3
Arm Type
Experimental
Arm Title
BI 425809 dose 4
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BI 425809 dose 1
Intervention Type
Drug
Intervention Name(s)
BI 425809 dose 2
Intervention Type
Drug
Intervention Name(s)
BI 425809 dose 3
Intervention Type
Drug
Intervention Name(s)
BI 425809 dose 4
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 Item (ADAS-Cog11) Total Score After 12 Weeks of Treatment
Description
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.
Time Frame
On day 1 (visit 2, baseline) and day 85 (end of trial)
Secondary Outcome Measure Information:
Title
Change From Baseline in the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Score After 12 Weeks of Treatment
Description
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 Examination
Time Frame
On day 1 (visit 2, baseline) and day 85 (end of trial)
Title
Clinician's Interview-Based Impression of Change (CIBIC+) Score After 12 Weeks of Treatment
Description
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
Time Frame
On day 1 (visit 2, baseline) and day 85 (end of trial)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Axiom Research LLC
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Alliance for Wellness
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
CITrials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Galiz Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Premier Clinical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Miami Jewish Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Bioclinica Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Neuro Trials Research Incorporated
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Millennium Psychiatric Associates LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63132
Country
United States
Facility Name
ANI Neurology, PLLC, dba Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Facility Name
Tulsa Clinical Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Northeastern Pennsylvania Memory and Alzheimer Center
City
Plains
State/Province
Pennsylvania
ZIP/Postal Code
18705
Country
United States
Facility Name
Roper St. Francis Healthcare
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
LKH-Univ. Hospital Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medical University of Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
SALK Christian-Doppler-Klinik,Paracel.Med.Privatuni.f.Neurol
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Private Practice for Psychiatry and Neurology
City
Vienna
ZIP/Postal Code
1130
Country
Austria
Facility Name
The Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 4N7
Country
Canada
Facility Name
True North Clinical Research Halifax, Inc.
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1M7
Country
Canada
Facility Name
True North Clinical Research Kentville, Inc.
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
Country
Canada
Facility Name
Bluewater Clinical Research
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Clinique Neuro-Outaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W2
Country
Canada
Facility Name
Diex Recherche
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 0H8
Country
Canada
Facility Name
Orton
City
Helsinki
ZIP/Postal Code
FI-00280
Country
Finland
Facility Name
University of Eastern Finland, Brain Research Unit
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Terveystalo Lahti
City
Lahti
ZIP/Postal Code
15110
Country
Finland
Facility Name
OYS, Neurologian tutkimusyksikkö
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
CRST - Clinical Research Services Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
HOP Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
HOP Pierre Wertheimer
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
HOP Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
HOP Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
HOP Nord Laënnec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
HOP La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU La Grave-Casselardit - Cité de la Santé
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
HOP Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
HOP des Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen
City
Bad Homburg
ZIP/Postal Code
61348
Country
Germany
Facility Name
Praxis Dr. med. Volker Schumann
City
Berlin
ZIP/Postal Code
10245
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Praxis Dr. Oehlwein
City
Gera
ZIP/Postal Code
07551
Country
Germany
Facility Name
Universitätsklinikum Köln (AöR)
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Pharmakologisches Studienzentrum Chemnitz
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Institut für Psychogerontologie
City
Nürnberg
ZIP/Postal Code
90408
Country
Germany
Facility Name
Neuropraxis München Süd, Unterhaching
City
Unterhaching
ZIP/Postal Code
82008
Country
Germany
Facility Name
Naval Hospital of Athens
City
Athens
ZIP/Postal Code
11521
Country
Greece
Facility Name
Eginition Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
University General Hospital Attikon
City
Athens
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Athens Medical Center
City
Athens
ZIP/Postal Code
15125
Country
Greece
Facility Name
University General Hospital of Thessaloniki AHEPA
City
Thessaloniki
ZIP/Postal Code
54621
Country
Greece
Facility Name
University General Hospital of Thessaloniki AHEPA
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
CRU Ltd, Neurology Dept., Miskolc
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
IRCCS Fondazione Ospedale Maggiore
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
A.O. San Gerardo di Monza
City
Monza (MB)
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Fujita Health University Hospital
City
Aichi, Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Inage Neurology and Memory Clinic
City
Chiba, Chiba
ZIP/Postal Code
263-0043
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Kagawa University Hospital
City
Kagawa, Kita-gun
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kawashima Neurology Clinic
City
Kanagawa, Fujisawa
ZIP/Postal Code
251-0038
Country
Japan
Facility Name
Ishikawa Clinic
City
Kyoto, Kyoto
ZIP/Postal Code
606-0851
Country
Japan
Facility Name
Nara Medical University Hospital
City
Nara, Kashihara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Katayama Medical Clinic
City
Okayama, Kurashiki
ZIP/Postal Code
710-0813
Country
Japan
Facility Name
National Hospital Organization Hizen Psychiatric Center
City
Saga, Kanzaki-gun
ZIP/Postal Code
842-0192
Country
Japan
Facility Name
National Center Neurology and Psychiatry
City
Tokyo, Kodaira
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Nozomi Memory Clinic
City
Tokyo, Mitaka
ZIP/Postal Code
181-0013
Country
Japan
Facility Name
Showa University East Hospital
City
Tokyo, Shinagawa
ZIP/Postal Code
142-0054
Country
Japan
Facility Name
Oslo Universitetssykehus HF, Hukommelsesklinikken
City
Oslo
ZIP/Postal Code
N-0450
Country
Norway
Facility Name
St. Olavs Hospital, Universitetssykehuset i Trondheim
City
Trondheim
ZIP/Postal Code
N-7030
Country
Norway
Facility Name
Podlassian Center of Psychogeriatry, Bialystok
City
Bialystok
ZIP/Postal Code
15-732
Country
Poland
Facility Name
Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-023
Country
Poland
Facility Name
Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
EUROMEDIS Sp. z o.o., Szczecin
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Sant Joan de Deu de Manresa
City
Manresa
ZIP/Postal Code
08423
Country
Spain
Facility Name
Hospital Universitari General de Catalunya
City
Sant Cugat del Vallès
ZIP/Postal Code
08190
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Viamed Montecanal
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
Facility Name
Royal Cornhill Hospital
City
Aberdeen
ZIP/Postal Code
AB25 2ZH
Country
United Kingdom
Facility Name
Fulbourn Hospital
City
Cambridge
ZIP/Postal Code
CB21 5EF
Country
United Kingdom
Facility Name
Ninewells Hospital & Medical School
City
Dundee
ZIP/Postal Code
DD2 1SY
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Warneford Hospital
City
Oxford
ZIP/Postal Code
OX3 7JX
Country
United Kingdom
Facility Name
Sheffield Memory Service
City
Sheffield
ZIP/Postal Code
S10 3TH
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trials.boehringer-ingelheim.com/
Description
Related Info

Learn more about this trial

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

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