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

October 18, 2018 updated by: Boehringer Ingelheim

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
329

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1130
        • Private Practice for Psychiatry and Neurology
  • Belgium
      • Brussel, Belgium, 1020
        • Brussels-UNIV Brugmann -Horta
      • Dendermonde, Belgium, 9200
        • AZ Sint-Blasius
      • Gent, Belgium, 9000
        • UNIV UZ Gent
      • Mons, Belgium, 7000
        • Mons - UNIV Ambroise Paré
  • Canada
      • Quebec, Canada, J1J 3H5
        • Institut universitaire de geriatrie Sherbrooke
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University Of Calgary
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 4M4
        • Dr. Alexander McIntyre Inc.
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
        • Pasqua Hospital
  • France
      • Bordeaux, France, 33076
        • HOP Pellegrin
      • Dijon, France, 21079
        • HOP Bocage
      • Marseille, France, 13385
        • HOP Timone
      • Montpellier, France, 34295
        • HOP Gui de Chauliac
      • Nantes, France, 44093
        • HOP Nord Laennec
      • Paris, France, 75651
        • HOP La Pitié Salpêtrière
      • Poitiers, France, 86021
        • HOP Jean Bernard, Géria, Poitiers
  • Germany
      • Berlin, Germany, 10629
        • Emovis GmbH
      • Berlin, Germany, 10245
        • Praxis Dr. med. Volker Schumann
      • Bochum, Germany, 44791
        • St. Josef- und St. Elisabeth-Hospital gGmbH
      • Erbach, Germany, 64711
        • Neuro Centrum Science GmbH
      • Leipzig, Germany, 04107
        • AFL Arzneimittelforschung Leipzig GmbH
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Mannheim, Germany, 68159
        • Zentralinstitut für Seelische Gesundheit
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm
      • Westerstede, Germany, 26655
        • Neurologie und Psychiatrie / Psychotherapie
  • Italy
      • Bologna, Italy, 40139
        • P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Careggi
      • Parma, Italy, 43126
        • Azienda Ospedaliera di Parma
  • Netherlands
      • 's-HERTOGENBOSCH, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis-Hertogenbosch
      • Amsterdam, Netherlands, 1081 GN
        • Brain Research Center
  • Poland
      • Bialystok, Poland, 15-756
        • Podlassian Center of Psychogeriatry, Bialystok
      • Kielce, Poland, 25-411
        • Mental Health Center Biomed
      • Lublin, Poland, 20-064
        • Non-Public Outpatient Clinic Neuromed M. i M. Nastaj
      • Lublin, Poland, 20-090
        • Inst. of Rural Health, Spec. Outp. Clin. & Rural Occup. Dis.
      • Poznan, Poland, 61-853
        • Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
      • Sopot, Poland, 81-855
        • Medical Center Senior
      • Szczecin, Poland, 70-111
        • EUROMEDIS Sp. z o.o., Szczecin
      • Wroclaw, Poland, 51-124
        • Reg. Specialist Hospital Wroclaw, Research & Develop. Center
  • Portugal
      • Amadora, Portugal, 2700-276
        • Hospital Fernando Fonseca, EPE
      • Braga, Portugal, 4710-243
        • Hospital de Braga-Escala Braga
      • Coimbra, Portugal, 3000-075
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
      • Guimarães, Portugal, 4835-044
        • Hospital Senhora Oliveira Guimarães,EPE
      • Lisboa, Portugal, 1349-019
        • CHLO, EPE - Hospital Egas Moniz
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Ângelo
      • Matosinhos, Portugal, 4454-509
        • ULSM, EPE - Hospital Pedro Hispano
      • Santa Maria da Feira, Portugal, 4520-211
        • Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Dundee, Scotland, United Kingdom, DD19SY
        • Ninewells Hospital & Medical School
      • Ivybridge, United Kingdom, PL219AB
        • West Devon (Tavistock) CMHT & Memory Clinic (EDI)
      • Plymouth, United Kingdom, PL6 8BT
        • Re-Cognition Health
  • United States
    • California
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research
    • Florida
      • Orlando, Florida, United States, 32806
        • Bioclinica Research
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Memory Enhancement Center of America, Inc.
    • New York
      • Rochester, New York, United States, 14623
        • Psychiatry and Alzheimer's Care of Rochester, PLLC
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • North Carolina
      • Charlotte, North Carolina, United States, 28270
        • ANI Neurology, PLLC, dba Alzheimer's Memory Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Tulsa Clinical Research, LLC
    • Vermont
      • Bennington, Vermont, United States, 05201
        • The Memory Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo comparator
Drug: Placebo
Drug: Placebo
for blinding purposes
Experimental: BI 409306 dose 1
Drug: Placebo
Drug: BI 409306
Drug: Placebo
for blinding purposes
Experimental: BI 409306 dose 2
Drug: Placebo
Drug: BI 409306
Drug: Placebo
for blinding purposes
Experimental: BI 409306 dose 3
Drug: Placebo
Drug: BI 409306
Drug: Placebo
for blinding purposes
Experimental: BI 409306 dose 4
Drug: Placebo
Drug: BI 409306
Drug: Placebo
for blinding purposes
Active Comparator: Active Comparator Donepezil
Drug: Placebo
Drug: Donepezil
Drug: Placebo
for blinding purposes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment.
Time Frame: Baseline and 12 weeks
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Least Squares Mean is actually an adjusted mean change from baseline.
Baseline and 12 weeks
Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment From Two Sister Trials, Present 1289.5 (NCT02240693) and 1289.7 (NCT02337907)
Time Frame: Baseline and 12 weeks
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. The number of low test scores decreased with higher levels of intellectual abilities. Least Squares Mean is actually an adjusted mean change from baseline.
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11) Total Score After 12-week Treatment
Time Frame: Baseline and 12 weeks
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog11) is an 11-item cognitive subscale that objectively measures memory, language, orientation, and praxis with a total score range of 0 to 70. The greater the dysfunction, the greater the score. Least Squares Mean is actually an adjusted mean change from baseline.
Baseline and 12 weeks
Change From Baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Total Score After 12-week Treatment
Time Frame: Baseline and 12 weeks
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) is a rating scale used to assess basic and instrumental activities of daily living. In the full version of the scale, 23 items are rated by the investigator using information supplied by the caregiver. Each item has a score range varying from 0-3 to 0-5. The sum score can range from 0 to 78. Higher scores indicate better function. Least Squares Mean is actually an adjusted mean change from baseline.
Baseline and 12 weeks
Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Total Score After 12-week Treatment
Time Frame: Baseline and 12 weeks
The CDR-SB is obtained through semi-structured interviews of patients and informants, and cognitive functioning was rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Each domain was rated on a 5-point scale of functioning as follows: 0-no impairment; 0.5-questionable impairment; 1-mild impairment; 2-moderate impairment and 3-severe impairment. Only personal care was scored on a 4-point scale without a 0.5 rating available. The higher the score, the greater the severity of dementia. Least Squares Mean is actually an adjusted mean change from baseline.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1289.7
  • 2013-005040-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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