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Trial record 1 of 1 for:    1346.23
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BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02788513
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE May 27, 2016
First Posted Date  ICMJE June 2, 2016
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE August 11, 2016
Actual Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
The change from baseline in ADAS-Cog11 (Alzheimer's Disease Assessment Scale-Cognitive subscale 11 item) total score [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
The change from baseline in ADAS-Cog13 (Alzheimer's Disease Assessment Scale - cognitive 13 item subscale) total score [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Change from baseline in the ADCS-ADL (Alzheimer's Disease Cooperative Study/Activities of Daily Living) score [ Time Frame: 12 weeks ]
  • CIBIC+ (Clinician's Interview-Based Impression of Change) score [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
  • Change from baseline in the ADCS-ADL (Alzheimer's Disease Cooperative Study/Activities of Daily Living) score [ Time Frame: 12 weeks ]
  • Change from baseline CDR-SB (Clinical Dementia Rating / Sum of Boxes) [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
Official Title  ICMJE A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy and Safety of Orally Administered BI 425809 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer's Disease.
Brief Summary The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: BI 425809 dose 1
  • Drug: BI 425809 dose 2
  • Drug: BI 425809 dose 3
  • Drug: BI 425809 dose 4
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: BI 425809 dose 1
    Interventions:
    • Drug: BI 425809 dose 1
    • Drug: Placebo
  • Experimental: BI 425809 dose 2
    Interventions:
    • Drug: BI 425809 dose 2
    • Drug: Placebo
  • Experimental: BI 425809 dose 3
    Interventions:
    • Drug: BI 425809 dose 3
    • Drug: Placebo
  • Experimental: BI 425809 dose 4
    Interventions:
    • Drug: BI 425809 dose 4
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2019)
611
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2016)
585
Actual Study Completion Date  ICMJE October 11, 2019
Actual Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Patients with early signs of dementia of Alzheimer Type
  • Male and female patients with an age of at least 55 years
  • Concomitant use of acetylcholinesterase inhibitors (AChEIs) is allowed but not required. 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 who are not currently taking AChEIs but have taken them in the past are also eligible if AChEIs were stopped at least 3 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 a reliable study partner (per investigator judgement, for instance a family member, partner etc., guardian)
  • Further inclusion criteria apply

Exclusion criteria:

  • Cognitive impairment or dementia with any etiology other than Alzheimer's Dementia (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
  • Patients receiving prescribed drugs for treatment of dementia of Alzheimer Type (other than Acetylcholine Esterase Inhibitors) at screening or within 3 months prior to screening
  • Previous participation in investigational drug studies of dementia of Alzheimer's Type within three months prior to screening. Patients having received any active treatment in studies targeting disease modification of AD are excluded. 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.
  • Further exclusion criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Japan,   Norway,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02788513
Other Study ID Numbers  ICMJE 1346.23
2015-005438-24 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP