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

Alzheimer Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788513
• Other study ID #: 1346.23
• Secondary ID: 2015-005438-24
• Status: Completed
• Phase: Phase 2
• Start date: August 11, 2016
• Est. completion date: October 11, 2019

Study information

• Verified date: October 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: October 11, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction

Intervention

Drug:
• BI 425809 dose 1

• BI 425809 dose 2

• BI 425809 dose 3

• BI 425809 dose 4

• Placebo

Locations

Country	Name	City	State
Austria	LKH-Univ. Hospital Graz	Graz
Austria	Medical University of Innsbruck	Innsbruck
Austria	SALK Christian-Doppler-Klinik,Paracel.Med.Privatuni.f.Neurol	Salzburg
Austria	Private Practice for Psychiatry and Neurology	Vienna
Canada	Clinique Neuro-Outaouais	Gatineau	Quebec
Canada	True North Clinical Research Halifax, Inc.	Halifax	Nova Scotia
Canada	The Medical Arts Health Research Group	Kelowna	British Columbia
Canada	True North Clinical Research Kentville, Inc.	Kentville	Nova Scotia
Canada	Bluewater Clinical Research	Sarnia	Ontario
Canada	Diex Recherche	Sherbrooke	Quebec
Finland	Orton	Helsinki
Finland	University of Eastern Finland, Brain Research Unit	Kuopio
Finland	Terveystalo Lahti	Lahti
Finland	OYS, Neurologian tutkimusyksikkö	Oulu
Finland	CRST - Clinical Research Services Turku	Turku
France	HOP Pellegrin	Bordeaux
France	HOP Pierre Wertheimer	Bron
France	HOP Roger Salengro	Lille
France	HOP Gui de Chauliac	Montpellier
France	HOP Nord Laënnec	Nantes
France	HOP La Pitié Salpêtrière	Paris
France	CHU La Grave-Casselardit - Cité de la Santé	Toulouse
France	HOP Brabois	Vandoeuvre les Nancy
France	HOP des Charpennes	Villeurbanne
Germany	Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen	Bad Homburg
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Praxis Dr. med. Volker Schumann	Berlin
Germany	Praxis Dr. Oehlwein	Gera
Germany	Universitätsklinikum Köln (AöR)	Köln
Germany	Pharmakologisches Studienzentrum Chemnitz	Mittweida
Germany	Institut für Psychogerontologie	Nürnberg
Germany	Neuropraxis München Süd, Unterhaching	Unterhaching
Greece	Athens Medical Center	Athens
Greece	Eginition Hospital	Athens
Greece	Naval Hospital of Athens	Athens
Greece	University General Hospital Attikon	Athens
Greece	University General Hospital of Thessaloniki AHEPA	Thessaloniki
Greece	University General Hospital of Thessaloniki AHEPA	Thessaloniki
Hungary	Semmelweis University	Budapest
Hungary	CRU Ltd, Neurology Dept., Miskolc	Miskolc
Hungary	University of Szeged	Szeged
Italy	IRCCS Fondazione Ospedale Maggiore	Milano
Italy	A.O. San Gerardo di Monza	Monza (MB)
Italy	Azienda Ospedaliera Universitaria di Padova	Padova
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Japan	Fujita Health University Hospital	Aichi, Toyoake
Japan	Inage Neurology and Memory Clinic	Chiba, Chiba
Japan	Sapporo Medical University Hospital	Hokkaido, Sapporo
Japan	Kagawa University Hospital	Kagawa, Kita-gun
Japan	Kawashima Neurology Clinic	Kanagawa, Fujisawa
Japan	Ishikawa Clinic	Kyoto, Kyoto
Japan	Nara Medical University Hospital	Nara, Kashihara
Japan	Katayama Medical Clinic	Okayama, Kurashiki
Japan	National Hospital Organization Hizen Psychiatric Center	Saga, Kanzaki-gun
Japan	National Center Neurology and Psychiatry	Tokyo, Kodaira
Japan	Nozomi Memory Clinic	Tokyo, Mitaka
Japan	Showa University East Hospital	Tokyo, Shinagawa
Norway	Oslo Universitetssykehus HF, Hukommelsesklinikken	Oslo
Norway	St. Olavs Hospital, Universitetssykehuset i Trondheim	Trondheim
Poland	Podlassian Center of Psychogeriatry, Bialystok	Bialystok
Poland	Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o	Bydgoszcz
Poland	Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners	Poznan
Poland	EUROMEDIS Sp. z o.o., Szczecin	Szczecin
Poland	Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun	Torun
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Sant Joan de Deu de Manresa	Manresa
Spain	Hospital Universitari General de Catalunya	Sant Cugat del Vallès
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Viamed Montecanal	Zaragoza
United Kingdom	Royal Cornhill Hospital	Aberdeen
United Kingdom	Fulbourn Hospital	Cambridge
United Kingdom	Ninewells Hospital & Medical School	Dundee
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Warneford Hospital	Oxford
United Kingdom	Sheffield Memory Service	Sheffield
United States	Neuro Trials Research Incorporated	Atlanta	Georgia
United States	The Memory Clinic	Bennington	Vermont
United States	Roper St. Francis Healthcare	Charleston	South Carolina
United States	ANI Neurology, PLLC, dba Alzheimer's Memory Center	Charlotte	North Carolina
United States	Axiom Research LLC	Colton	California
United States	MD Clinical	Hallandale Beach	Florida
United States	Alliance for Wellness	Long Beach	California
United States	Galiz Research	Miami	Florida
United States	Miami Jewish Health System	Miami	Florida
United States	Premier Clinical Research Institute	Miami	Florida
United States	Northeastern Pennsylvania Memory and Alzheimer Center	Plains	Pennsylvania
United States	Anderson Clinical Research	Redlands	California
United States	Millennium Psychiatric Associates LLC	Saint Louis	Missouri
United States	CITrials	Santa Ana	California
United States	Stedman Clinical Trials	Tampa	Florida
United States	Bioclinica Research	The Villages	Florida
United States	Tulsa Clinical Research, LLC	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Norway,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 Item (ADAS-Cog11) Total Score After 12 Weeks of Treatment	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	Change From Baseline in the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Score After 12 Weeks of Treatment	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)
Secondary	Clinician's Interview-Based Impression of Change (CIBIC+) Score After 12 Weeks of Treatment	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)

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