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



Status:Recruiting
Conditions:Alzheimer Disease, Cognitive Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:55 - Any
Updated:4/4/2019
Start Date:August 11, 2016
End Date:October 18, 2019
Contact:Boehringer Ingelheim Call Center
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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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.

The study is designed to compare the effects of BI 425809 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

- 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
We found this trial at
21
sites
Long Beach, California 90807
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
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3212 Cove Bend Drive
Tampa, Florida 33613
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Atlanta, Georgia 30342
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Atlanta, GA
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Bennington, Vermont 05201
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Bennington, VT
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Buffalo, NY
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Charleston, South Carolina 29401
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Charleston, SC
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Charlotte, North Carolina 28211
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Charlotte, NC
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Colton, California 92324
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Colton, CA
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Graz,
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Jupiter, Florida 33458
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Jupiter, FL
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Miami, Florida 33016
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Miami, FL
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Oklahoma City, Oklahoma 73116
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Oklahoma City, OK
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Plains, PA
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Redlands, California 92374
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Redlands, CA
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Saint Louis, Missouri 63132
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Saint Louis, MO
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Santa Ana, California 92705
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Santa Ana, CA
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3201 Wedgewood Lane
The Villages, Florida 32162
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The Villages, FL
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Tulsa, Oklahoma 74104
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Tulsa, OK
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