A multi-centre, double-blind, parallel-group, randomized controlled study to investigate the efficacy, safety and tolerability of orally administred BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer's disease.

Alzheimer*s disease (AD), a chronic progressive mental disorder, is the most
common cause of dementia and accounts for 50 to 70 % of all cases. AD is mainly
a disorder of the elderly; The age-specific prevalence of AD almost doubles
every 5 years after age 65. Among developed nations,
approximately 1 in 10 elderly people (65+ years) is affected by dementia to
some degree, In the prodromal stage of the disease, clinical symptoms may
include impairment of episodic memory and/or other cognitive domains, like
executive function, orientation and judgment.
Patients with these prodromal clinical symptoms showed an increased risk of
developing Alzheimer*s dementia with progressive decline in the ability to
perform activities of daily living and the appearance of behavioral changes
and/or psychiatric symptoms (mood
disturbances, hallucinations, personality changes). Subsequently and in
accordance with the further progression of the disease there is an increasing
utilization of resources and medical care finally leading to the need for
full-time assisted living . The median time from onset of symptoms to death is
estimated to be around 10 years.Currently approved AD treatment is purely
symptomatic and only approved for Mild to Moderate AD This treatment isn*t
approved for prodromal stages of the disease.
Patients with prodromal AD have an increased risk of eventually developing
Alzheimer's dementia. Therefore, a symptomatic treatment that
delays the progress of these first symptoms cause by the underlying pathology
might provide a substantial benefit to such patients.
A symptomatic treatment that proves to be more efficacious than the currently
available compounds (AChEIs,
memantine) in improving both existing cognition deficits and the ability to
better perform activities of daily living would provide a substantial benefit
to patients.

The primary objective of this study is to assess efficacy and safety of BI
409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily
compared to placebo over a 12-week treatment period in male and female patients
at least 55 years of age with prodromal AD.

This is a 12-week, multi-center, randomized, double-blind, double dummy placebo
controlled, parallel group study in patients with AD.
In total, 288 patients with prodromal AD who meet the entry criteria are
planned to be randomized in this trial.
After obtaining informed consent, patients will undergo a screening period of a
maximum of 5 weeks. All patients who successfully complete the screening period
and are eligible for the study, then enter a minimum of 2 weeks of single
blinded placebo run-in before
randomization. Patients who successfully complete the single-blinded phase and
who fulfil both the inclusion and exclusion criteria will be randomized to the
12-week double blind treatment period at visit3 and will be assigned to one of
the 5 treatment groups namely: once daily (QD) 10 mg, 25 mg, or 50 mg BI
409306, or 25 mg BI 409306 twice daily (BID), or placebo.

See table 4.1.1. of the clinical trial protocol

5 week screening period, 2 week run-in periode (v 1 and 2), 12 week treatment
period with 5 visits and 2 phone calls, 1 follow up visit

Physical examination
Heart rate, breathing rate, and blood pressure
Questions for patient and study partner to complete
Blood taken for routine tests, PK, vitamin B12 and folate levels
Blood taken for testing of Syphilis and HIV
Urine taken for a pregnancy test and a drug screening test (if applicable).
Optional blood samples will be collected for additional biomarkers
Liver Function Tests (from safety lab sample)
Urine taken for routine tests
ECG (electrocardiogram)
1 x MRI (Magnetic Resonance Imaging)- if applicable
1 x CSF sampling. Not necessary if a useful past CSF sample or PET scan result
are available