BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
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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
Actual Study Start Date :
January 21, 2015
Actual Primary Completion Date :
September 15, 2017
Actual Study Completion Date :
October 10, 2017
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Ages Eligible for Study:
55 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with early signs of dementia of Alzheimer Type
Male and female patients with an age of at least 55 years
Previous use of 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)
Cognitive impairment or dementia with any etiology other than 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/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.