Alzheimer Disease Proof of Concept Study With BI 409306 Versus Placebo
- Conditions
- Alzheimer Disease
- Interventions
- Drug: BI 409306Drug: Placebo
- Registration Number
- NCT02240693
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The study is designed to compare the effects of 4 different doses of orally administered BI 409306 to placebo in patients with Alzheimers Disease
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 409306 dose 1 BI 409306 - BI 409306 dose 1 Placebo - BI 409306 dose 2 Placebo - BI 409306 dose 2 BI 409306 - BI 409306 dose 3 BI 409306 - BI 409306 dose 3 Placebo - BI 409306 dose 4 BI 409306 - BI 409306 dose 4 Placebo - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment From Two Twin 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 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. Change from baseline will be calculated as the post-baseline composite z-score minus the pre-treatment z-score, such that a positive change indicates an improvement from baseline
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 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. Change from baseline will be calculated as the post-baseline composite z-score minus the pre-treatment z-score, such that a positive change indicates an improvement from baseline
- Secondary Outcome Measures
Name Time Method Change From Baseline in ADCS-MCI-ADL (Alzheimer's Disease Cooperative Study/Activities of Daily Living for Patients With Mild Cognitive Impairment) 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 (52)
emovis GmbH
🇩🇪Berlin, Germany
HOP Jean Bernard, Géria, Poitiers
🇫🇷Poitiers, France
Praxis Dr. med. Volker Schumann
🇩🇪Berlin, Germany
HOP Nord Laënnec
🇫🇷Nantes, France
HOP La Pitié Salpêtrière
🇫🇷Paris, France
Podlassian Center of Psychogeriatry, Bialystok
🇵🇱Bialystok, Poland
Brain Research Center
🇳🇱Amsterdam, Netherlands
AFL Arzneimittelforschung Leipzig GmbH
🇩🇪Leipzig, Germany
HOP Pierre Wertheimer
🇫🇷Bron, France
HOP Gui de Chauliac
🇫🇷Montpellier, France
Institut universitaire de geriatrie Sherbrooke
🇨🇦Quebec, Canada
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcon (Madrid), Spain
Hospital ClÃnic de Barcelona
🇪🇸Barcelona, Spain
CHLO, EPE - Hospital Egas Moniz
🇵🇹Lisboa, Portugal
Osp. S. Giovanni di Dio
🇮🇹Firenze, Italy
Zentralinstitut für seelische Gesundheit
🇩🇪Mannheim, Germany
A.O. Spedali Civili di Brescia
🇮🇹Brescia, Italy
Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
Non-Public Outpatient Clinic "Synapsa" Pawel Polrola, Kielce
🇵🇱Kielce, Poland
University of Calgary
🇨🇦Calgary, Alberta, Canada
California Neuroscience Research
🇺🇸Sherman Oaks, California, United States
Memory Enhancement Center of America, Inc.
🇺🇸Eatontown, New Jersey, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Tulsa Clinical Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Private Practice for Psychiatry and Neurology
🇦🇹Wien, Austria
Landeskrankenhaus Hall, Abt.f. Psychatrie & Psychotherapie A
🇦🇹Hall in Tirol, Austria
Brussels-UNIV Brugmann -Horta
🇧🇪Brussel, Belgium
Royal Jubilee Hospital
🇨🇦Victoria, British Columbia, Canada
True North Clinical Research Kentville, Inc.
🇨🇦Kentville, Nova Scotia, Canada
True North Clinical Research Halifax, Inc.
🇨🇦Halifax, Nova Scotia, Canada
Policlinico Gemelli
🇮🇹Roma, Italy
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Neurologie und Psychiatrie / Psychotherapie
🇩🇪Westerstede, Germany
Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o
🇵🇱Bydgoszcz, Poland
Mental Health Center Biomed
🇵🇱Kielce, Poland
Re-Cognition Health
🇬🇧Plymouth, United Kingdom
Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
🇵🇱Poznan, Poland
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
🇵🇹Coimbra, Portugal
EUROMEDIS Sp. z o.o., Szczecin
🇵🇱Szczecin, Poland
Hospital Fernando Fonseca, EPE
🇵🇹Amadora, Portugal
Reg. Specialist Hospital Wroclaw, Research & Develop. Center
🇵🇱Wroclaw, Poland
CHLN, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Hospital Universitario Virgen de la Arrixaca
🇪🇸El Palmar (murcia), Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitari General de Catalunya
🇪🇸Sant Cugat del Vallès, Spain
Hospital Mútua Terrassa
🇪🇸Terrasa (Barcelona), Spain
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Royal United Hospital
🇬🇧Bath, United Kingdom
Medical Center Senior
🇵🇱Sopot, Poland
ANI Neurology, PLLC, dba Alzheimer's Memory Center
🇺🇸Charlotte, North Carolina, United States
Orange County Neuropsychiatric Research Center LLC
🇺🇸Orange, California, United States