BI 409306 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
Placebo
Placebo
BI 409306
Donepezil
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer 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
- Previous use of Alzheimer's Disease (AD) medications (AChEIs, memantine) is allowed up 3 month prior to screening. 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 currently taking memantine are excluded.
- 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 or, if applicable, a legal representative)
Exclusion criteria:
- Cognitive impairment or dementia with any etiology other than Alzheimer's Disease (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
- Any other psychiatric disorders such as schizophrenia, or mental retardation
- Previous participation in investigational drug studies of mild cognitive impairment/Dementia of Alzheimer Type (DAT) within three months prior to screening. Having received active treatment in any other study targeting disease modification of AD like Aß immunization and tau therapies. 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.
Sites / Locations
- California Neuroscience Research
- Bioclinica Research
- Premiere Research Institute
- Indiana University
- Memory Enhancement Center of America, Inc.
- Psychiatry And Alzheimer's Care of Rochester, PLLC
- Richmond Behavioral Associates
- ANI Neurology, PLLC, dba Alzheimer's Memory Center
- Tulsa Clinical Research, LLC
- The Memory Clinic
- Private Practice for Psychiatry and Neurology
- Brussels-UNIV Brugmann -Horta
- AZ Sint-Blasius
- UNIV UZ Gent
- Mons - UNIV Ambroise Paré
- University of Calgary
- Dr. Alexander McIntyre Inc.
- Pasqua Hospital
- Institut universitaire de geriatrie Sherbrooke
- HOP Pellegrin
- HOP Bocage
- HOP Timone
- HOP Gui de Chauliac
- HOP Nord Laënnec
- HOP La Pitié Salpêtrière
- HOP Jean Bernard, Géria, Poitiers
- Praxis Dr. med. Volker Schumann
- emovis GmbH
- St. Josef- und St. Elisabeth-Hospital gGmbH
- Neuro Centrum Science GmbH
- AFL Arzneimittelforschung Leipzig GmbH
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Zentralinstitut für seelische Gesundheit
- Universitätsklinikum Ulm
- Neurologie und Psychiatrie / Psychotherapie
- P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna
- Azienda Ospedaliera Careggi
- Azienda Ospedaliera di Parma
- Jeroen Bosch Ziekenhuis-Hertogenbosch
- Brain Research Center
- Podlassian Center of Psychogeriatry, Bialystok
- Mental Health Center Biomed
- Non-Public Outpatient Clinic Neuromed M. i M. Nastaj
- Inst. of Rural Health, Spec. Outp. Clin. & Rural Occup. Dis.
- Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
- Medical Center Senior
- EUROMEDIS Sp. z o.o., Szczecin
- Reg. Specialist Hospital Wroclaw, Research & Develop. Center
- Hospital Fernando Fonseca, EPE
- Hospital de Braga-Escala Braga
- CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
- Hospital Senhora Oliveira Guimarães,EPE
- CHLO, EPE - Hospital Egas Moniz
- Hospital Beatriz Ângelo
- ULSM, EPE - Hospital Pedro Hispano
- Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
- Royal United Hospital
- Ninewells Hospital & Medical School
- West Devon (Tavistock) CMHT & Memory Clinic (EDI)
- Re-Cognition Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Active Comparator
Experimental
Arm Label
Placebo comparator
BI 409306 dose 1
BI 409306 dose 2
BI 409306 dose 3
Active Comparator Donepezil
BI 409306 dose 4
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment.
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Least Squares Mean is actually an adjusted mean change from baseline.
Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment From Two Sister Trials, Present 1289.5 (NCT02240693) and 1289.7 (NCT02337907)
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. The number of low test scores decreased with higher levels of intellectual abilities. Least Squares Mean is actually an adjusted mean change from baseline.
Secondary Outcome Measures
Change From Baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Total Score After 12-week Treatment
Alzheimer's Disease Cooperative Study/Activities of Daily Living (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 can range from 0 to 78. Higher scores indicate better function. Least Squares Mean is actually an adjusted mean change from baseline.
Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Total Score After 12-week Treatment
The CDR-SB is obtained through semi-structured interviews of patients and informants, and cognitive functioning was rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Each domain was rated on a 5-point scale of functioning as follows: 0-no impairment; 0.5-questionable impairment; 1-mild impairment; 2-moderate impairment and 3-severe impairment. Only personal care was scored on a 4-point scale without a 0.5 rating available. The higher the score, the greater the severity of dementia. Least Squares Mean is actually an adjusted mean change from baseline.
Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11) Total Score After 12-week Treatment
Alzheimer's Disease Assessment Scale-cognitive subscale (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. The greater the dysfunction, the greater the score. Least Squares Mean is actually an adjusted mean change from baseline.
Full Information
NCT ID
NCT02337907
First Posted
December 23, 2014
Last Updated
October 18, 2018
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02337907
Brief Title
BI 409306 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, Safety and Tolerability of Orally Administered BI 409306 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 2018
Overall Recruitment Status
Completed
Study Start Date
January 21, 2015 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
October 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The study is designed to compare the effects of BI 409306 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
329 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm Title
BI 409306 dose 1
Arm Type
Experimental
Arm Title
BI 409306 dose 2
Arm Type
Experimental
Arm Title
BI 409306 dose 3
Arm Type
Experimental
Arm Title
Active Comparator Donepezil
Arm Type
Active Comparator
Arm Title
BI 409306 dose 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
for blinding purposes
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
BI 409306
Intervention Type
Drug
Intervention Name(s)
Donepezil
Primary Outcome Measure Information:
Title
Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment.
Description
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Least Squares Mean is actually an adjusted mean change from baseline.
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment From Two Sister Trials, Present 1289.5 (NCT02240693) and 1289.7 (NCT02337907)
Description
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. The number of low test scores decreased with higher levels of intellectual abilities. Least Squares Mean is actually an adjusted mean change from baseline.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Total Score After 12-week Treatment
Description
Alzheimer's Disease Cooperative Study/Activities of Daily Living (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 can range from 0 to 78. Higher scores indicate better function. Least Squares Mean is actually an adjusted mean change from baseline.
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Total Score After 12-week Treatment
Description
The CDR-SB is obtained through semi-structured interviews of patients and informants, and cognitive functioning was rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Each domain was rated on a 5-point scale of functioning as follows: 0-no impairment; 0.5-questionable impairment; 1-mild impairment; 2-moderate impairment and 3-severe impairment. Only personal care was scored on a 4-point scale without a 0.5 rating available. The higher the score, the greater the severity of dementia. Least Squares Mean is actually an adjusted mean change from baseline.
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11) Total Score After 12-week Treatment
Description
Alzheimer's Disease Assessment Scale-cognitive subscale (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. The greater the dysfunction, the greater the score. Least Squares Mean is actually an adjusted mean change from baseline.
Time Frame
Baseline and 12 weeks
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
Previous use of Alzheimer's Disease (AD) medications (AChEIs, memantine) is allowed up 3 month prior to screening. 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 currently taking memantine are excluded.
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 or, if applicable, a legal representative)
Exclusion criteria:
Cognitive impairment or dementia with any etiology other than Alzheimer's Disease (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
Any other psychiatric disorders such as schizophrenia, or mental retardation
Previous participation in investigational drug studies of mild cognitive impairment/Dementia of Alzheimer Type (DAT) within three months prior to screening. Having received active treatment in any other study targeting disease modification of AD like Aß immunization and tau therapies. 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.
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
California Neuroscience Research
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Memory Enhancement Center of America, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Psychiatry And Alzheimer's Care of Rochester, PLLC
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
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
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Private Practice for Psychiatry and Neurology
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Brussels-UNIV Brugmann -Horta
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
Facility Name
AZ Sint-Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Facility Name
UNIV UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Mons - UNIV Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Dr. Alexander McIntyre Inc.
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 4M4
Country
Canada
Facility Name
Pasqua Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada
Facility Name
Institut universitaire de geriatrie Sherbrooke
City
Quebec
ZIP/Postal Code
J1J 3H5
Country
Canada
Facility Name
HOP Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
HOP Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
HOP Timone
City
Marseille
ZIP/Postal Code
13385
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
HOP Jean Bernard, Géria, Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Praxis Dr. med. Volker Schumann
City
Berlin
ZIP/Postal Code
10245
Country
Germany
Facility Name
emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
St. Josef- und St. Elisabeth-Hospital gGmbH
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Neuro Centrum Science GmbH
City
Erbach
ZIP/Postal Code
64711
Country
Germany
Facility Name
AFL Arzneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Zentralinstitut für seelische Gesundheit
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Neurologie und Psychiatrie / Psychotherapie
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Azienda Ospedaliera Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliera di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Jeroen Bosch Ziekenhuis-Hertogenbosch
City
's-HERTOGENBOSCH
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Brain Research Center
City
Amsterdam
ZIP/Postal Code
1081 GN
Country
Netherlands
Facility Name
Podlassian Center of Psychogeriatry, Bialystok
City
Bialystok
ZIP/Postal Code
15-756
Country
Poland
Facility Name
Mental Health Center Biomed
City
Kielce
ZIP/Postal Code
25-411
Country
Poland
Facility Name
Non-Public Outpatient Clinic Neuromed M. i M. Nastaj
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Inst. of Rural Health, Spec. Outp. Clin. & Rural Occup. Dis.
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Medical Center Senior
City
Sopot
ZIP/Postal Code
81-855
Country
Poland
Facility Name
EUROMEDIS Sp. z o.o., Szczecin
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Reg. Specialist Hospital Wroclaw, Research & Develop. Center
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Hospital Fernando Fonseca, EPE
City
Amadora
ZIP/Postal Code
2700-276
Country
Portugal
Facility Name
Hospital de Braga-Escala Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Senhora Oliveira Guimarães,EPE
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
CHLO, EPE - Hospital Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Hospital Beatriz Ângelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
ULSM, EPE - Hospital Pedro Hispano
City
Matosinhos
ZIP/Postal Code
4454-509
Country
Portugal
Facility Name
Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Ninewells Hospital & Medical School
City
Dundee, Scotland
ZIP/Postal Code
DD19SY
Country
United Kingdom
Facility Name
West Devon (Tavistock) CMHT & Memory Clinic (EDI)
City
Ivybridge
ZIP/Postal Code
PL219AB
Country
United Kingdom
Facility Name
Re-Cognition Health
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30755255
Citation
Frolich L, Wunderlich G, Thamer C, Roehrle M, Garcia M Jr, Dubois B. Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer's disease. Alzheimers Res Ther. 2019 Feb 12;11(1):18. doi: 10.1186/s13195-019-0467-2.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
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