BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
NCT ID: NCT02337907
Last Updated: 2018-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
329 participants
INTERVENTIONAL
2015-01-21
2017-10-10
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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Placebo comparator
Placebo
for blinding purposes
Placebo
BI 409306 dose 1
Placebo
for blinding purposes
BI 409306
BI 409306 dose 2
Placebo
for blinding purposes
BI 409306
BI 409306 dose 3
Placebo
for blinding purposes
BI 409306
Active Comparator Donepezil
Placebo
for blinding purposes
Donepezil
BI 409306 dose 4
Placebo
for blinding purposes
BI 409306
Interventions
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Placebo
for blinding purposes
Placebo
BI 409306
Donepezil
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
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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California Neuroscience Research
Sherman Oaks, California, United States
Bioclinica Research
Orlando, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Psychiatry And Alzheimer's Care of Rochester, PLLC
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
ANI Neurology, PLLC, dba Alzheimer's Memory Center
Charlotte, North Carolina, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States
The Memory Clinic
Bennington, Vermont, United States
Private Practice for Psychiatry and Neurology
Vienna, , Austria
Brussels-UNIV Brugmann -Horta
Brussels, , Belgium
AZ Sint-Blasius
Dendermonde, , Belgium
UNIV UZ Gent
Ghent, , Belgium
Mons - UNIV Ambroise Paré
Mons, , Belgium
University of Calgary
Calgary, Alberta, Canada
Dr. Alexander McIntyre Inc.
Penticton, British Columbia, Canada
Pasqua Hospital
Regina, Saskatchewan, Canada
Institut universitaire de geriatrie Sherbrooke
Québec, , Canada
HOP Pellegrin
Bordeaux, , France
HOP Bocage
Dijon, , France
HOP Timone
Marseille, , France
HOP Gui de Chauliac
Montpellier, , France
HOP Nord Laënnec
Nantes, , France
HOP La Pitié Salpêtrière
Paris, , France
HOP Jean Bernard, Géria, Poitiers
Poitiers, , France
Praxis Dr. med. Volker Schumann
Berlin, , Germany
emovis GmbH
Berlin, , Germany
St. Josef- und St. Elisabeth-Hospital gGmbH
Bochum, , Germany
Neuro Centrum Science GmbH
Erbach im Odenwald, , Germany
AFL Arzneimittelforschung Leipzig GmbH
Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Zentralinstitut für seelische Gesundheit
Mannheim, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Neurologie und Psychiatrie / Psychotherapie
Westerstede, , Germany
P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna
Bologna, , Italy
Azienda Ospedaliera Careggi
Florence, , Italy
Azienda Ospedaliera di Parma
Parma, , Italy
Jeroen Bosch Ziekenhuis-Hertogenbosch
's-Hertogenbosch, , Netherlands
Brain Research Center
Amsterdam, , Netherlands
Podlassian Center of Psychogeriatry, Bialystok
Bialystok, , Poland
Mental Health Center Biomed
Kielce, , Poland
Non-Public Outpatient Clinic Neuromed M. i M. Nastaj
Lublin, , Poland
Inst. of Rural Health, Spec. Outp. Clin. & Rural Occup. Dis.
Lublin, , Poland
Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
Poznan, , Poland
Medical Center Senior
Sopot, , Poland
EUROMEDIS Sp. z o.o., Szczecin
Szczecin, , Poland
Reg. Specialist Hospital Wroclaw, Research & Develop. Center
Wroclaw, , Poland
Hospital Fernando Fonseca, EPE
Amadora, , Portugal
Hospital de Braga-Escala Braga
Braga, , Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, , Portugal
Hospital Senhora Oliveira Guimarães,EPE
Guimarães, , Portugal
CHLO, EPE - Hospital Egas Moniz
Lisbon, , Portugal
Hospital Beatriz Ângelo
Loures, , Portugal
ULSM, EPE - Hospital Pedro Hispano
Matosinhos Municipality, , Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, , Portugal
Royal United Hospital
Bath, , United Kingdom
Ninewells Hospital & Medical School
Dundee, Scotland, , United Kingdom
West Devon (Tavistock) CMHT & Memory Clinic (EDI)
Ivybridge, , United Kingdom
Re-Cognition Health
Plymouth, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2013-005040-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1289.7
Identifier Type: -
Identifier Source: org_study_id
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