BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
- Registration Number
- NCT02337907
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 329
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 409306 dose 3 BI 409306 - Placebo comparator Placebo - BI 409306 dose 1 Placebo - BI 409306 dose 1 BI 409306 - BI 409306 dose 2 Placebo - BI 409306 dose 2 BI 409306 - BI 409306 dose 3 Placebo - Active Comparator Donepezil Placebo - Active Comparator Donepezil Donepezil - BI 409306 dose 4 Placebo - BI 409306 dose 4 BI 409306 -
- Primary Outcome Measures
Name Time Method Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment. Baseline and 12 weeks 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) Baseline and 12 weeks 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
Name Time Method Change From Baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Total Score After 12-week Treatment Baseline and 12 weeks 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 Baseline and 12 weeks 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 Baseline and 12 weeks 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.
Trial Locations
- Locations (60)
HOP La Pitié Salpêtrière
🇫🇷Paris, France
Praxis Dr. med. Volker Schumann
🇩🇪Berlin, Germany
HOP Pellegrin
🇫🇷Bordeaux, France
HOP Jean Bernard, Géria, Poitiers
🇫🇷Poitiers, France
Medical Center Senior
🇵🇱Sopot, Poland
Hospital Senhora Oliveira Guimarães,EPE
🇵🇹Guimarães, Portugal
AFL Arzneimittelforschung Leipzig GmbH
🇩🇪Leipzig, Germany
Institut universitaire de geriatrie Sherbrooke
🇨🇦Quebec, Canada
Azienda Ospedaliera Careggi
🇮🇹Firenze, Italy
HOP Gui de Chauliac
🇫🇷Montpellier, France
HOP Bocage
🇫🇷Dijon, France
Royal United Hospital
🇬🇧Bath, United Kingdom
Non-Public Outpatient Clinic Neuromed M. i M. Nastaj
🇵🇱Lublin, Poland
emovis GmbH
🇩🇪Berlin, Germany
Ninewells Hospital & Medical School
🇬🇧Dundee, Scotland, United Kingdom
St. Josef- und St. Elisabeth-Hospital gGmbH
🇩🇪Bochum, Germany
Neuro Centrum Science GmbH
🇩🇪Erbach, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Brain Research Center
🇳🇱Amsterdam, Netherlands
Zentralinstitut für seelische Gesundheit
🇩🇪Mannheim, Germany
P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna
🇮🇹Bologna, Italy
Re-Cognition Health
🇬🇧Plymouth, United Kingdom
Indiana University
🇺🇸Indianapolis, Indiana, United States
Azienda Ospedaliera di Parma
🇮🇹Parma, Italy
Bioclinica Research
🇺🇸Orlando, Florida, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Psychiatry And Alzheimer's Care of Rochester, PLLC
🇺🇸Rochester, New York, United States
Brussels-UNIV Brugmann -Horta
🇧🇪Brussel, Belgium
The Memory Clinic
🇺🇸Bennington, Vermont, United States
Private Practice for Psychiatry and Neurology
🇦🇹Wien, Austria
ANI Neurology, PLLC, dba Alzheimer's Memory Center
🇺🇸Charlotte, North Carolina, United States
AZ Sint-Blasius
🇧🇪Dendermonde, Belgium
Mons - UNIV Ambroise Paré
🇧🇪Mons, Belgium
UNIV UZ Gent
🇧🇪Gent, Belgium
University of Calgary
🇨🇦Calgary, Alberta, Canada
Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
HOP Timone
🇫🇷Marseille, France
HOP Nord Laënnec
🇫🇷Nantes, France
Podlassian Center of Psychogeriatry, Bialystok
🇵🇱Bialystok, Poland
Jeroen Bosch Ziekenhuis-Hertogenbosch
🇳🇱's-HERTOGENBOSCH, Netherlands
Mental Health Center Biomed
🇵🇱Kielce, Poland
West Devon (Tavistock) CMHT & Memory Clinic (EDI)
🇬🇧Ivybridge, United Kingdom
Tulsa Clinical Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
California Neuroscience Research
🇺🇸Sherman Oaks, California, United States
Memory Enhancement Center of America, Inc.
🇺🇸Eatontown, New Jersey, United States
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Neurologie und Psychiatrie / Psychotherapie
🇩🇪Westerstede, Germany
Hospital Fernando Fonseca, EPE
🇵🇹Amadora, Portugal
Hospital de Braga-Escala Braga
🇵🇹Braga, Portugal
Inst. of Rural Health, Spec. Outp. Clin. & Rural Occup. Dis.
🇵🇱Lublin, Poland
Reg. Specialist Hospital Wroclaw, Research & Develop. Center
🇵🇱Wroclaw, Poland
Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
🇵🇱Poznan, Poland
CHLO, EPE - Hospital Egas Moniz
🇵🇹Lisboa, Portugal
EUROMEDIS Sp. z o.o., Szczecin
🇵🇱Szczecin, Poland
Hospital Beatriz Ângelo
🇵🇹Loures, Portugal
Dr. Alexander McIntyre Inc.
🇨🇦Penticton, British Columbia, Canada
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
🇵🇹Coimbra, Portugal
ULSM, EPE - Hospital Pedro Hispano
🇵🇹Matosinhos, Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
🇵🇹Santa Maria da Feira, Portugal