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BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

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ClinicalTrials.gov Identifier: NCT02788513
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: BI 425809 dose 1 Drug: BI 425809 dose 2 Drug: BI 425809 dose 3 Drug: BI 425809 dose 4 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : August 11, 2016
Estimated Primary Completion Date : February 4, 2020
Estimated Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 425809 dose 1 Drug: BI 425809 dose 1
Drug: Placebo
Experimental: BI 425809 dose 2 Drug: BI 425809 dose 2
Drug: Placebo
Experimental: BI 425809 dose 3 Drug: BI 425809 dose 3
Drug: Placebo
Experimental: BI 425809 dose 4 Drug: BI 425809 dose 4
Drug: Placebo
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. The change from baseline in ADAS-Cog11 (Alzheimer's Disease Assessment Scale-Cognitive subscale 11 item) total score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in the ADCS-ADL (Alzheimer's Disease Cooperative Study/Activities of Daily Living) score [ Time Frame: 12 weeks ]
  2. CIBIC+ (Clinician's Interview-Based Impression of Change) score [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788513


Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02788513     History of Changes
Other Study ID Numbers: 1346.23
2015-005438-24 ( EudraCT Number )
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders