BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.



Status:Completed
Conditions:Alzheimer Disease, Cognitive Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:55 - Any
Updated:11/16/2018
Start Date:January 21, 2015
End Date:October 10, 2017

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A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy, Safety and Tolerability of Orally Administered BI 409306 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer's Disease

The study is designed to compare the effects of BI 409306 compared to placebo in patients
with cognitive impairment due to Alzheimer's Disease


Inclusion criteria:

- Patients with early signs of dementia of Alzheimer Type

- Male and female patients with an age of at least 55 years

- Previous use of Alzheimer's Disease (AD) medications (AChEIs, memantine) is allowed up
3 month prior to screening. 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 currently taking memantine
are excluded.

- 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 or, if applicable, a legal representative)

Exclusion criteria:

- Cognitive impairment or dementia with any etiology other than Alzheimer's Disease (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

- Any other psychiatric disorders such as schizophrenia, or mental retardation

- Previous participation in investigational drug studies of mild cognitive
impairment/Dementia of Alzheimer Type (DAT) within three months prior to screening.
Having received active treatment in any other study targeting disease modification of
AD like Aß immunization and tau therapies. 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.
We found this trial at
11
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Bennington, Vermont 05201
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Charlotte, North Carolina 28211
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Eatontown, New Jersey 07724
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100 West Gore Street
Orlando, Florida 32806
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1200 Jefferson Road
Rochester, New York 14623
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Sherman Oaks, California 91403
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Staten Island, New York 10312
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Tulsa, Oklahoma 74104
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West Palm Beach, Florida 33407
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20 Lainzer Straße
Wien, 1130
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