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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005031-24 | EudraCT Number |
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The study is designed to compare the effects of 4 different doses of orally administered BI 409306 to placebo in patients with Alzheimers Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 409306 dose 1 | Experimental |
| |
| BI 409306 dose 2 | Experimental |
| |
| BI 409306 dose 3 | Experimental |
| |
| BI 409306 dose 4 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 409306 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 | Baseline and 12 weeks |
| 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) | 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 | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
Not provided
Inclusion criteria:
Mini-Mental State Examination (MMSE) score: greater or equal 24 and a global Clinical Dementia Rating (CDR)-score of 0 or 0.5 and
Free and Cued Selective Recall Reminding Test (FCSRT) score:
free recall test: lower or equal 20 (out of 48) and total recall test: lower or equal 42 (out of 48)
Patients who do not reach the required score in FCSRT will additionally perform the Wechsler Memory Visual Paired Associates test. If the Wechsler Memory Visual Paired Associates test shows a cognitive deficit worse than 1 standard deviation to the mean (compared to the reference values of age and educational norms for inclusion), then the patients can be considered to be eligible for the study.
Confirmation of abnormal markers of AD pathology either via a), or alternatively b) mentioned below:
Presence in cerebrospinal fluid of (samples taken within past 4 months may be eligible,:
low Aß1-42 concentrations (< 640 pg/mL) and increased total tau concentrations (> 375 pg/ml), or / and low Aß1-42 concentrations (< 640 pg/mL) and increased phospho-tau concentrations (> 52 pg/mL in cerebrospinal fluid), or
Abnormal amyloid deposition in a cerebral Positron Emission Tomography (PET) scan. Scans performed in the past according to the recommendation in the protocol are acceptable
Patients who have not received prescribed drugs for treatment of AD (including acetyl cholinesterase inhibitors (donepezil, galantamine, rivastigmine, tacrine, phenserine) and Memantine within three months prior to screening
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 given written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to any study procedures. All patients must be able to give informed consent personally and have capacity for such consent. An informed consent given by a legal representative will not be accepted.
Patients must have a reliable study partner (per investigator judgement, for instance a family member, partner, guardian etc.)
Exclusion criteria:
Mild cognitive impairment with any etiology other than prodromal AD (for example: neurosyphilis, craniocerebral trauma, small vessel disease) based on clinical data and/or current laboratory findings and/or a pre-existing MRI or CT of the brain (CCT). If previous cranial imaging is not available or older than 12 months prior to screening then a CCT or MRI needs to be performed at screening
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 of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
Medical history or diagnosis of any of symptomatic and unstable/uncontrolled conditions per investigator judgement
Severe renal impairment defined with a glomerular filtration rate (GFR) < 30ml/min/1.73m2 in the screening central lab report
Any other psychiatric disorders such as schizophrenia, or mental retardation
Any suicidal actions in the past 2 years (per investigator judgement i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
Previous participation in investigational drug studies of mild cognitive impairment within three months prior to screening. Having received active treatment in any other study targeting disease modification like Aß immunization and tau therapies. Previous participation in studies with non-prescription medications, vitamins or other nutritional formulations is allowed.
Significant history of drug dependence or abuse (including alcohol, as defined in Diagnostic and Statistical Manual of Mental Disorders [DSM-V] or in the opinion of the investigator) within the last two years, or a positive urine drug screen for cocaine, heroin, or marijuana.
Known history of HIV infection
Any planned surgeries requiring general anaesthesia, or hospitalisation for more than 1 day during the study period
Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control
For male patients: Men who are able to father a child, unwilling to be abstinent or to use an adequate form of effective contraception for the duration of study participation and for at least 28 days after treatment has ended.
Use of any investigational drug or procedure for other indications within 3 months or 6 half-lives (whichever is longer) prior to randomization.
Intake of the following medications within 3 months prior to randomization and intended to be initiated during the duration of the trial:
The following drugs may be given as needed if the total daily dose was stable 8 weeks prior to randomisation and is expected to be for the duration of the trial:
neuroleptics listed in the protocol
benzodiazepines and sedatives listed in the protocol
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Neuropsychiatric Research Center LLC | Orange | California | 92868 | United States | ||
| California Neuroscience Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30755255 | Derived | 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. |
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For this trial, patients were randomised at 36 sites in 11 countries. Following an initial Screening Visit and a single blinded 2-week placebo run-in period, patients who qualified according to the in- and exclusion criteria were randomised to one of the five treatment groups
A multi-centre, double-blind, parallel-group, randomized controlled study to investigate the efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer's Disease
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BI 409306 10 Milligram (mg) Once Daily (QD) | Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks. |
| FG001 | BI 409306 25 mg QD | Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2017 | Sep 11, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BI 409306 | Drug |
|
| Placebo | Drug |
|
| Placebo | Drug |
|
| BI 409306 | Drug |
|
| BI 409306 | Drug |
|
| Placebo | Drug |
|
| Placebo | Drug |
|
| Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| Sherman Oaks |
| California |
| 91403 |
| United States |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | United States |
| Memory Enhancement Center of America, Inc. | Eatontown | New Jersey | 07724 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| ANI Neurology, PLLC, dba Alzheimer's Memory Center | Charlotte | North Carolina | 28270 | United States |
| Tulsa Clinical Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| Landeskrankenhaus Hall, Abt.f. Psychatrie & Psychotherapie A | Hall in Tirol | 6060 | Austria |
| Private Practice for Psychiatry and Neurology | Vienna | 1130 | Austria |
| Brussels-UNIV Brugmann -Horta | Brussels | 1020 | Belgium |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Royal Jubilee Hospital | Victoria | British Columbia | V8R 1J8 | Canada |
| True North Clinical Research Halifax, Inc. | Halifax | Nova Scotia | B3S 1M7 | Canada |
| True North Clinical Research Kentville, Inc. | Kentville | Nova Scotia | B4B 4K9 | Canada |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| Institut universitaire de geriatrie Sherbrooke | Québec | J1J 3H5 | Canada |
| HOP Pierre Wertheimer | Bron | 69677 | France |
| HOP Gui de Chauliac | Montpellier | 34295 | France |
| HOP Nord Laënnec | Nantes | 44093 | France |
| HOP La Pitié Salpêtrière | Paris | 75651 | France |
| HOP Jean Bernard, Géria, Poitiers | Poitiers | 86021 | France |
| Praxis Dr. med. Volker Schumann | Berlin | 10245 | Germany |
| emovis GmbH | Berlin | 10629 | Germany |
| AFL Arzneimittelforschung Leipzig GmbH | Leipzig | 04107 | Germany |
| Zentralinstitut für seelische Gesundheit | Mannheim | 68159 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Neurologie und Psychiatrie / Psychotherapie | Westerstede | 26655 | Germany |
| A.O. Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Osp. S. Giovanni di Dio | Florence | 50143 | Italy |
| Policlinico Gemelli | Roma | 00168 | Italy |
| Brain Research Center | Amsterdam | 1081 GN | Netherlands |
| Podlassian Center of Psychogeriatry, Bialystok | Bialystok | 15-732 | Poland |
| Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o | Bydgoszcz | 85-796 | Poland |
| Non-Public Outpatient Clinic "Synapsa" Pawel Polrola, Kielce | Kielce | 25-103 | Poland |
| Mental Health Center Biomed | Kielce | 25-411 | Poland |
| Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners | Poznan | 61-853 | Poland |
| Medical Center Senior | Sopot | 81-855 | Poland |
| EUROMEDIS Sp. z o.o., Szczecin | Szczecin | 70-111 | Poland |
| Reg. Specialist Hospital Wroclaw, Research & Develop. Center | Wroclaw | 51-124 | Poland |
| Hospital Fernando Fonseca, EPE | Amadora | 2700-276 | Portugal |
| CHUC - Centro Hospitalar e Universitário de Coimbra, EPE | Coimbra | 3000-075 | Portugal |
| CHLO, EPE - Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| CHLN, EPE - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Hospital Universitario Fundación Alcorcón | Alcorcon (Madrid) | 28922 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario Virgen de la Arrixaca | El Palmar (murcia) | 30120 | Spain |
| Hospital Universitari General de Catalunya | Sant Cugat del Vallès | 08190 | Spain |
| Hospital Mútua Terrassa | Terrasa (Barcelona) | 08221 | Spain |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Derriford Hospital | Plymouth | PL21 9AB | United Kingdom |
| Re-Cognition Health | Plymouth | PL6 8BT | United Kingdom |
| FG002 | BI 409306 50 mg QD | Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks. |
| FG003 | BI 409306 25 mg Twice Daily (BID) | Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks. |
| FG004 | Placebo Matching BI 409306 | Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set:
The treated set (TS) included all patients who were randomised and treated with at least one dose of trial medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BI 409306 10 Milligram (mg) Once Daily (QD) | Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks. |
| BG001 | BI 409306 25 mg QD | Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks. |
| BG002 | BI 409306 50 mg QD | Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks. |
| BG003 | BI 409306 25 mg Twice Daily (BID) | Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks. |
| BG004 | Placebo Matching BI 409306 | Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Race data is presented below; Ethnicity was not reported in this trial | Count of Participants | Participants |
| |||||||||||||||
| Neuropsychological Test Battery (NTB) Total | Baseline cognitive assessment data- NTB total z-score. 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. Higher values indicate a better Outcome | Mean | Standard Deviation | z-score |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 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 | The full analysis set (FAS) included all randomised patients who were treated with at least one dose of trial medication and had a baseline and at least one post-baseline on-treatment efficacy assessment. Observed cases (OC) | Posted | Least Squares Mean | Standard Error | z-score | Baseline and 12 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | FAS- Observed cases | Posted | Least Squares Mean | Standard Error | Unit on scale | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS- Observed cases | Posted | Least Squares Mean | Standard Error | Unit on scale | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS- Observed cases | Posted | Least Squares Mean | Standard Error | Unit on scale | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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) | 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 | FAS observed cases for pooled groups of these twin trials | Posted | Least Squares Mean | Standard Error | z-score | Baseline and 12 weeks |
|
From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 409306 10 Milligram (mg) Once Daily (QD) | Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks. | 0 | 22 | 0 | 22 | 5 | 22 |
| EG001 | BI 409306 25 mg QD | Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks. | 0 | 21 | 0 | 21 | 8 | 21 |
| EG002 | BI 409306 50 mg QD | Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks. | 0 | 21 | 0 | 21 | 11 | 21 |
| EG003 | BI 409306 25 mg Twice Daily (BID) | Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks. | 0 | 21 | 1 | 21 | 3 | 21 |
| EG004 | Placebo Matching BI 409306 | Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks. | 0 | 43 | 1 | 43 | 6 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2017 | Sep 11, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630656 | BI 409306 |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo. |
The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. |
| Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. | Mixed Model Repeated Measurement (MMRM) | Kenward-Roger was used to model degrees of freedom. | 0.3694 | p-value was nominal and not adjusted. | Mean Difference (Final Values) | -0.07 | Standard Error of the Mean | 0.076 | 2-Sided | 95 | -0.220 | 0.082 | Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306) | Superiority | H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo. | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences. |
| Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. | Mixed Model Repeated Measurement (MMRM) | Kenward-Roger was used to model degrees of freedom. | 0.8374 | p-value was nominal and not adjusted. | Mean Difference (Final Values) | -0.02 | Standard Error of the Mean | 0.078 | 2-Sided | 95 | -0.171 | 0.139 | Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306) | Superiority | H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo. | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences |
| Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. | Mixed Model Repeated Measurement (MMRM) | Kenward-Roger was used to model degrees of freedom. | 0.5484 | p-value was nominal and not adjusted. | Mean Difference (Final Values) | 0.05 | Standard Error of the Mean | 0.077 | 2-Sided | 95 | -0.106 | 0.199 | Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306) | Superiority | H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo. | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences |
| Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. | Mixed Model Repeated Measurement (MMRM) | Kenward-Roger was used to model degrees of freedom. | 0.7905 | p-value was nominal and not adjusted. | Mean Difference (Final Values) | 0.01 | Standard Error of the Mean | 0.054 | 2-Sided | 95 | -0.092 | 0.121 | Mean difference (Pooled BI 409306 minus Placebo matching BI 409306) | Superiority | H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo. | The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences |
| OG003 | BI 409306 25 mg Twice Daily (BID) | Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks. |
| OG004 | Placebo Matching BI 409306 | Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks |
|
|
|
| OG003 | BI 409306 25 mg Twice Daily (BID) | Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks. |
| OG004 | Placebo Matching BI 409306 | Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks |
|
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Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
| OG004 | Placebo Matching BI 409306 | Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks |
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| OG003 | BI 409306 25 mg Twice Daily (BID) | Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks. |
| OG004 | Pooled BI 409306 | Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks. |
| OG005 | Placebo Matching BI 409306 | Patients were administered orally Placebo matching 10 mg/25 mg/ 50 mg BI 409306 for 12 weeks |
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