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

October 16, 2020 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

611

Phase

  • 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
      • Graz, Austria, 8036
        • LKH-Univ. Hospital Graz
      • Innsbruck, Austria, 6020
        • Medical University of Innsbruck
      • Salzburg, Austria, 5020
        • SALK Christian-Doppler-Klinik,Paracel.Med.Privatuni.f.Neurol
      • Vienna, Austria, 1130
        • Private Practice for Psychiatry and Neurology
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 4N7
        • The Medical Arts Health Research Group
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1M7
        • True North Clinical Research Halifax, Inc.
      • Kentville, Nova Scotia, Canada, B4N 4K9
        • True North Clinical Research Kentville, Inc.
    • Ontario
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 1W2
        • Clinique Neuro-Outaouais
      • Sherbrooke, Quebec, Canada, J1H 0H8
        • Diex Recherche
  • Finland
      • Helsinki, Finland, FI-00280
        • Orton
      • Kuopio, Finland, 70210
        • University of Eastern Finland, Brain Research Unit
      • Lahti, Finland, 15110
        • Terveystalo Lahti
      • Oulu, Finland, 90220
        • OYS, Neurologian tutkimusyksikkö
      • Turku, Finland, 20520
        • CRST - Clinical Research Services Turku
  • France
      • Bordeaux, France, 33076
        • HOP Pellegrin
      • Bron, France, 69677
        • HOP Pierre Wertheimer
      • Lille, France, 59037
        • HOP Roger Salengro
      • Montpellier, France, 34295
        • HOP Gui de Chauliac
      • Nantes, France, 44093
        • HOP Nord Laennec
      • Paris, France, 75651
        • HOP La Pitié Salpêtrière
      • Toulouse, France, 31052
        • CHU La Grave-Casselardit - Cité de la Santé
      • Vandoeuvre les Nancy, France, 54500
        • HOP Brabois
      • Villeurbanne, France, 69100
        • HOP des Charpennes
  • Germany
      • Bad Homburg, Germany, 61348
        • Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen
      • Berlin, Germany, 12200
        • Charite - Universitatsmedizin Berlin
      • Berlin, Germany, 10245
        • Praxis Dr. med. Volker Schumann
      • Berlin, Germany, 13125
        • Charite - Universitatsmedizin Berlin
      • Gera, Germany, 07551
        • Praxis Dr. Oehlwein
      • Köln, Germany, 50937
        • Universitätsklinikum Köln (AöR)
      • Mittweida, Germany, 09648
        • Pharmakologisches Studienzentrum Chemnitz
      • Nürnberg, Germany, 90408
        • Institut fur Psychogerontologie
      • Unterhaching, Germany, 82008
        • Neuropraxis München Süd, Unterhaching
  • Greece
      • Athens, Greece, 15125
        • Athens Medical Center
      • Athens, Greece, 11521
        • Naval Hospital of Athens
      • Athens, Greece, 124 62
        • University General Hospital Attikon
      • Athens, Greece, 11528
        • Eginition Hospital
      • Thessaloniki, Greece, 54636
        • University General Hospital of Thessaloniki AHEPA
      • Thessaloniki, Greece, 54621
        • University General Hospital of Thessaloniki AHEPA
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis University
      • Miskolc, Hungary, 3526
        • CRU Ltd, Neurology Dept., Miskolc
      • Szeged, Hungary, 6725
        • University of Szeged
  • Italy
      • Milano, Italy, 20122
        • IRCCS Fondazione Ospedale Maggiore
      • Monza (MB), Italy, 20900
        • A.O. San Gerardo di Monza
      • Padova, Italy, 35128
        • Azienda Ospedaliera Universitaria di Padova
      • Pisa, Italy, 56126
        • Azienda Ospedaliera Universitaria Pisana
  • Japan
      • Aichi, Toyoake, Japan, 470-1192
        • Fujita Health University Hospital
      • Chiba, Chiba, Japan, 263-0043
        • Inage Neurology and Memory Clinic
      • Hokkaido, Sapporo, Japan, 060-8543
        • Sapporo Medical University Hospital
      • Kagawa, Kita-gun, Japan, 761-0793
        • Kagawa University Hospital
      • Kanagawa, Fujisawa, Japan, 251-0038
        • Kawashima Neurology Clinic
      • Kyoto, Kyoto, Japan, 606-0851
        • Ishikawa Clinic
      • Nara, Kashihara, Japan, 634-8522
        • Nara Medical University Hospital
      • Okayama, Kurashiki, Japan, 710-0813
        • Katayama Medical Clinic
      • Saga, Kanzaki-gun, Japan, 842-0192
        • National Hospital Organization Hizen Psychiatric Center
      • Tokyo, Kodaira, Japan, 187-8551
        • National Center Neurology and Psychiatry
      • Tokyo, Mitaka, Japan, 181-0013
        • Nozomi Memory Clinic
      • Tokyo, Shinagawa, Japan, 142-0054
        • Showa University East Hospital
  • Norway
      • Oslo, Norway, N-0450
        • Oslo Universitetssykehus HF, Hukommelsesklinikken
      • Trondheim, Norway, N-7030
        • St. Olavs Hospital, Universitetssykehuset i Trondheim
  • Poland
      • Bialystok, Poland, 15-732
        • Podlassian Center of Psychogeriatry, Bialystok
      • Bydgoszcz, Poland, 85-023
        • Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o
      • Poznan, Poland, 61-853
        • Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
      • Szczecin, Poland, 70-111
        • EUROMEDIS Sp. z o.o., Szczecin
      • Torun, Poland, 87-100
        • Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Manresa, Spain, 08423
        • Hospital Sant Joan de Déu de Manresa
      • Sant Cugat del Vallès, Spain, 08190
        • Hospital Universitari General de Catalunya
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Zaragoza, Spain, 50012
        • Hospital Viamed Montecanal
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZH
        • Royal Cornhill Hospital
      • Cambridge, United Kingdom, CB21 5EF
        • Fulbourn Hospital
      • Dundee, United Kingdom, DD2 1SY
        • Ninewells Hospital & Medical School
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
      • Oxford, United Kingdom, OX3 7JX
        • Warneford Hospital
      • Sheffield, United Kingdom, S10 3TH
        • Sheffield Memory Service
  • United States
    • California
      • Colton, California, United States, 92324
        • Axiom Research LLC
      • Long Beach, California, United States, 90807
        • Alliance for Wellness
      • Redlands, California, United States, 92374
        • Anderson Clinical Research
      • Santa Ana, California, United States, 92705
        • CiTrials
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Miami, Florida, United States, 33122
        • Premier Clinical Research Institute
      • Miami, Florida, United States, 33016
        • Galiz Research
      • Miami, Florida, United States, 33137
        • Miami Jewish Health System
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • The Villages, Florida, United States, 32162
        • Bioclinica Research
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Neuro Trials Research Incorporated
    • Missouri
      • Saint Louis, Missouri, United States, 63132
        • Millennium Psychiatric Associates LLC
    • 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
    • Pennsylvania
      • Plains, Pennsylvania, United States, 18705
        • Northeastern Pennsylvania Memory and Alzheimer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper St. Francis Healthcare
    • 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

Ages Eligible for Study

53 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
  • 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

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
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: BI 425809 dose 1
Drug: Placebo
Drug: BI 425809 dose 1
Experimental: BI 425809 dose 2
Drug: Placebo
Drug: BI 425809 dose 2
Experimental: BI 425809 dose 3
Drug: Placebo
Drug: BI 425809 dose 3
Experimental: BI 425809 dose 4
Drug: Placebo
Drug: BI 425809 dose 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 Item (ADAS-Cog11) Total Score After 12 Weeks of Treatment
Time Frame: On day 1 (visit 2, baseline) and day 85 (end of trial)

The 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, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline.

Multiple comparison procedures and modelling (MCPmod) in combination with mixed model repeated measures (MMRM) is used for primary analysis of the primary endpoint.

MMRM included fixed, categorical covariates of treatment, visit, baseline Mini Mental State Examination MMSE (>=20, <20) and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. Patient was considered as random effect. The unstructured covariance structure was used to model the within patient measurements. The same MMRM model used in the primary analysis is used for the secondary analysis of the primary endpoint.
On day 1 (visit 2, baseline) and day 85 (end of trial)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Score After 12 Weeks of Treatment
Time Frame: On day 1 (visit 2, baseline) and day 85 (end of trial)

Change from baseline in the ADCS-ADL score after 12 weeks of treatment is presented.

The 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 could range from 0 to 78, with higher scores indicating less severe impairment. A positive change indicates an improvement from baseline.

Abbreviation: MMSE = Mini Mental State Examination
On day 1 (visit 2, baseline) and day 85 (end of trial)
Clinician's Interview-Based Impression of Change (CIBIC+) Score After 12 Weeks of Treatment
Time Frame: On day 1 (visit 2, baseline) and day 85 (end of trial)

Clinician's Interview-Based Impression of Change (CIBIC+) score is based on semi-structured interview covering domains of function and cognition. It additionally requires the assessment of psychiatric signs and symptoms. The patient and their caregiver are interviewed and questioned by the clinician. Change rate is based on an unanchored 7-point scale (with 0 being not assessed, 1-3 being very much improved to minimally improved, 4 being no change, and 5-7 being minimally worse to very much worse).

For the ANCOVA model, the baseline value for CIBIC+ is represented by CIBIS which is clinician's interview-based impression of severity score (scores range from 0-7, with 0 being not assessed, 1 being normal, and 7 being most extremely ill) in order to adjust for potential baseline heterogeneity.

Abbreviation: MMSE = Mini Mental State Examination
On day 1 (visit 2, baseline) and day 85 (end of trial)

Collaborators and Investigators

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

Sponsor

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.

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)

August 11, 2016

Primary Completion (Actual)

September 12, 2019

Study Completion (Actual)

October 11, 2019

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1346.23
  • 2015-005438-24 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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