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

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ClinicalTrials.gov Identifier: NCT02337907
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Placebo Drug: BI 409306 Drug: Donepezil Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Primary Completion Date : September 15, 2017
Study Completion Date : October 10, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo comparator Drug: Placebo
for blinding purposes
Drug: Placebo
Experimental: BI 409306 dose 1 Drug: Placebo
for blinding purposes
Drug: BI 409306
Experimental: BI 409306 dose 2 Drug: Placebo
for blinding purposes
Drug: BI 409306
Experimental: BI 409306 dose 3 Drug: Placebo
for blinding purposes
Drug: BI 409306
Active Comparator: Active Comparator Donepezil Drug: Placebo
for blinding purposes
Drug: Donepezil
Experimental: BI 409306 dose 4 Drug: Placebo
for blinding purposes
Drug: BI 409306

Primary Outcome Measures :
  1. Cognition as measured by change from baseline in Neuropsychological Test Battery (NTB) in total z-score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) total score [ Time Frame: 12 weeks ]
  2. Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale 11 item (ADAS-cog11) [ Time Frame: 12 weeks ]
  3. Change from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) total score [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337907

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02337907     History of Changes
Other Study ID Numbers: 1289.7
2013-005040-28 ( EudraCT Number )
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents