BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: BI 425809 dose 1; BI 425809 dose 2; BI 425809 dose 3; BI 425809 dose 4; Placebo
Intervention MeSH terms: BI 425809
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 611.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

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.
    

Eligibility 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