Clinical trial NCT02337907: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 329
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 409306 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
* 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.

Primary outcomes:
measure: Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment.
timeFrame: Baseline and 12 weeks
measure: 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)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change From Baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Total Score After 12-week Treatment
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Total Score After 12-week Treatment
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11) Total Score After 12-week Treatment
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Sherman Oaks
country: United States
facility: California Neuroscience Research
state: California
city: Orlando
country: United States
facility: Bioclinica Research
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Rochester
country: United States
facility: Psychiatry And Alzheimer's Care of Rochester, PLLC
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
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: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Wien
country: Austria
facility: Private Practice for Psychiatry and Neurology
city: Brussel
country: Belgium
facility: Brussels-UNIV Brugmann -Horta
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Gent
country: Belgium
facility: UNIV UZ Gent
city: Mons
country: Belgium
facility: Mons - UNIV Ambroise Paré
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Penticton
country: Canada
facility: Dr. Alexander McIntyre Inc.
state: British Columbia
city: Regina
country: Canada
facility: Pasqua Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: Institut universitaire de geriatrie Sherbrooke
city: Bordeaux
country: France
facility: HOP Pellegrin
city: Dijon
country: France
facility: HOP Bocage
city: Marseille
country: France
facility: HOP Timone
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: Poitiers
country: France
facility: HOP Jean Bernard, Géria, Poitiers
city: Berlin
country: Germany
facility: Praxis Dr. med. Volker Schumann
city: Berlin
country: Germany
facility: emovis GmbH
city: Bochum
country: Germany
facility: St. Josef- und St. Elisabeth-Hospital gGmbH
city: Erbach
country: Germany
facility: Neuro Centrum Science GmbH
city: Leipzig
country: Germany
facility: AFL Arzneimittelforschung Leipzig GmbH
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Zentralinstitut für seelische Gesundheit
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Westerstede
country: Germany
facility: Neurologie und Psychiatrie / Psychotherapie
city: Bologna
country: Italy
facility: P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna
city: Firenze
country: Italy
facility: Azienda Ospedaliera Careggi
city: Parma
country: Italy
facility: Azienda Ospedaliera di Parma
city: 's-HERTOGENBOSCH
country: Netherlands
facility: Jeroen Bosch Ziekenhuis-Hertogenbosch
city: Amsterdam
country: Netherlands
facility: Brain Research Center
city: Bialystok
country: Poland
facility: Podlassian Center of Psychogeriatry, Bialystok
city: Kielce
country: Poland
facility: Mental Health Center Biomed
city: Lublin
country: Poland
facility: Non-Public Outpatient Clinic Neuromed M. i M. Nastaj
city: Lublin
country: Poland
facility: Inst. of Rural Health, Spec. Outp. Clin. & Rural Occup. Dis.
city: Poznan
country: Poland
facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
city: Sopot
country: Poland
facility: Medical Center Senior
city: Szczecin
country: Poland
facility: EUROMEDIS Sp. z o.o., Szczecin
city: Wroclaw
country: Poland
facility: Reg. Specialist Hospital Wroclaw, Research & Develop. Center
city: Amadora
country: Portugal
facility: Hospital Fernando Fonseca, EPE
city: Braga
country: Portugal
facility: Hospital de Braga-Escala Braga
city: Coimbra
country: Portugal
facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
city: Guimarães
country: Portugal
facility: Hospital Senhora Oliveira Guimarães,EPE
city: Lisboa
country: Portugal
facility: CHLO, EPE - Hospital Egas Moniz
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo
city: Matosinhos
country: Portugal
facility: ULSM, EPE - Hospital Pedro Hispano
city: Santa Maria da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Dundee, Scotland
country: United Kingdom
facility: Ninewells Hospital & Medical School
city: Ivybridge
country: United Kingdom
facility: West Devon (Tavistock) CMHT & Memory Clinic (EDI)
city: Plymouth
country: United Kingdom
facility: Re-Cognition Health
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
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.