Alzheimer DiseasePhase 2NCT02788513
BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
A Phase 2 study testing BI 425809 dose 1, BI 425809 dose 2 and BI 425809 dose 3 in people with Alzheimer Disease, run by Boehringer Ingelheim at 95 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- BI 425809 dose 1, BI 425809 dose 2 and BI 425809 dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 611 participants
- Where
- 95 sitesin 14 countries
- Study dates
- 11 Aug 2016to 11 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
95 sites in 14 countries.
95 sites in 14 countries
United States17 sites
Neuro Trials Research Incorporated
Atlanta, Georgia, 30342
The Memory Clinic
Bennington, Vermont, 05201
Roper St. Francis Healthcare
Charleston, South Carolina, 29401
ANI Neurology, PLLC, dba Alzheimer's Memory Center
Charlotte, North Carolina, 28270
Axiom Research LLC
Colton, California, 92324
MD Clinical
Hallandale, Florida, 33009
Alliance for Wellness
Long Beach, California, 90807
Galiz Research
Miami, Florida, 33016
Premier Clinical Research Institute
Miami, Florida, 33122
Miami Jewish Health System
Miami, Florida, 33137
Northeastern Pennsylvania Memory and Alzheimer Center
Plains, Pennsylvania, 18705
Anderson Clinical Research
Redlands, California, 92374
CITrials
Santa Ana, California, 92705
Millennium Psychiatric Associates LLC
St Louis, Missouri, 63132
Stedman Clinical Trials
Tampa, Florida, 33613
Bioclinica Research
The Villages, Florida, 32162
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104
Japan12 sites
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Inage Neurology and Memory Clinic
Chiba, Chiba, 263-0043
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793
Kawashima Neurology Clinic
Kanagawa, Fujisawa, 251-0038
Ishikawa Clinic
Kyoto, Kyoto, 606-0851
Nara Medical University Hospital
Nara, Kashihara, 634-8522
Katayama Medical Clinic
Okayama, Kurashiki, 710-0813
National Hospital Organization Hizen Psychiatric Center
Saga, Kanzaki-gun, 842-0192
National Center Neurology and Psychiatry
Tokyo, Kodaira, 187-8551
Nozomi Memory Clinic
Tokyo, Mitaka, 181-0013
Showa University East Hospital
Tokyo, Shinagawa, 142-0054
France9 sites
HOP Pellegrin
Bordeaux, 33076
HOP Pierre Wertheimer
Bron, 69677
HOP Roger Salengro
Lille, 59037
HOP Gui de Chauliac
Montpellier, 34295
HOP Nord Laënnec
Nantes, 44093
HOP La Pitié Salpêtrière
Paris, 75651
CHU La Grave-Casselardit - Cité de la Santé
Toulouse, 31052
HOP Brabois
Vandœuvre-lès-Nancy, 54500
HOP des Charpennes
Villeurbanne, 69100
Germany9 sites
Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen
Bad Homburg, 61348
Praxis Dr. med. Volker Schumann
Berlin, 10245
Charité - Universitätsmedizin Berlin
Berlin, 12200
Charité - Universitätsmedizin Berlin
Berlin, 13125
Universitätsklinikum Köln (AöR)
Cologne, 50937
Praxis Dr. Oehlwein
Gera, 07551
Pharmakologisches Studienzentrum Chemnitz
Mittweida, 09648
Institut für Psychogerontologie
Nuremberg, 90408
Neuropraxis München Süd, Unterhaching
Unterhaching, 82008
United Kingdom7 sites
Royal Cornhill Hospital
Aberdeen, AB25 2ZH
Fulbourn Hospital
Cambridge, CB21 5EF
Ninewells Hospital & Medical School
Dundee, DD2 1SY
Western General Hospital
Edinburgh, EH4 2XU
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Warneford Hospital
Oxford, OX3 7JX
Sheffield Memory Service
Sheffield, S10 3TH
Canada6 sites
Clinique Neuro-Outaouais
Gatineau, Quebec, J8Y 1W2
True North Clinical Research Halifax, Inc.
Halifax, Nova Scotia, B3S 1M7
The Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 4N7
True North Clinical Research Kentville, Inc.
Kentville, Nova Scotia, B4N 4K9
Bluewater Clinical Research
Sarnia, Ontario, N7T 4X3
Diex Recherche
Sherbrooke, Quebec, J1H 0H8
Greece6 sites
Naval Hospital of Athens
Athens, 11521
Eginition Hospital
Athens, 11528
University General Hospital Attikon
Athens, 124 62
Athens Medical Center
Athens, 15125
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54621
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54636
Spain6 sites
Hospital del Mar
Barcelona, 08003
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Sant Joan de Deu de Manresa
Manresa, 08423
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, 08190
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Viamed Montecanal
Zaragoza, 50012
Finland5 sites
Orton
Helsinki, FI-00280
University of Eastern Finland, Brain Research Unit
Kuopio, 70210
Terveystalo Lahti
Lahti, 15110
OYS, Neurologian tutkimusyksikkö
Oulu, 90220
CRST - Clinical Research Services Turku
Turku, 20520
Poland5 sites
Podlassian Center of Psychogeriatry, Bialystok
Bialystok, 15-732
Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o
Bydgoszcz, 85-023
Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
Poznan, 61-853
EUROMEDIS Sp. z o.o., Szczecin
Szczecin, 70-111
Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
Torun, 87-100
Austria4 sites
LKH-Univ. Hospital Graz
Graz, 8036
Medical University of Innsbruck
Innsbruck, 6020
SALK Christian-Doppler-Klinik,Paracel.Med.Privatuni.f.Neurol
Salzburg, 5020
Private Practice for Psychiatry and Neurology
Vienna, 1130
Italy4 sites
IRCCS Fondazione Ospedale Maggiore
Milan, 20122
A.O. San Gerardo di Monza
Monza (MB), 20900
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Hungary3 sites
Semmelweis University
Budapest, 1083
CRU Ltd, Neurology Dept., Miskolc
Miskolc, 3526
University of Szeged
Szeged, 6725
Norway2 sites
Oslo Universitetssykehus HF, Hukommelsesklinikken
Oslo, N-0450
St. Olavs Hospital, Universitetssykehuset i Trondheim
Trondheim, N-7030
About this study
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.
The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.
- Conditions
- Alzheimer Disease
- Being tested
- BI 425809 dose 1, BI 425809 dose 2, BI 425809 dose 3, BI 425809 dose 4, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 425809 dose 1Drug
BI 425809 dose 2Drug
BI 425809 dose 3Drug
BI 425809 dose 4Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 425809 dose 1 | Experimental | Not described Receives: Drug: BI 425809 dose 1; Drug: Placebo |
| BI 425809 dose 2 | Experimental | Not described Receives: Drug: BI 425809 dose 2; Drug: Placebo |
| BI 425809 dose 3 | Experimental | Not described Receives: Drug: BI 425809 dose 3; Drug: Placebo |
| BI 425809 dose 4 | Experimental | Not described Receives: Drug: BI 425809 dose 4; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On day 1 (visit 2, baseline) and day 85 (end of trial)
Secondary outcomes (2)
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
Measured: 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
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
Measured: On day 1 (visit 2, baseline) and day 85 (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start11 Aug 2016
- Primary completion12 Sep 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788513
- Sponsor's protocol ID
- 1346.23
- Other IDs
- 2015-005438-24, 2015
- Status last verified
- Oct 2020
- First submitted
- 27 May 2016
- Last updated
- 6 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wunderlich G, Blahova Z, Garcia M, Jessen F. Efficacy and safety of the novel GlyT1 inhibitor BI 425809 in Alzheimer's dementia: a randomized controlled trial. Alzheimers Res Ther. 2023 Jan 28;15(1):24. doi: 10.1186/s13195-023-01163-3.
PubMed 36709275
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02788513
- Acronym / sponsor ID
- 1346.23
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Posted 6 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BI 425809 dose 1 | Experimental | Drug: BI 425809 dose 1, Drug: Placebo |
| BI 425809 dose 2 | Experimental | Drug: BI 425809 dose 2, Drug: Placebo |
| BI 425809 dose 3 | Experimental | Drug: BI 425809 dose 3, Drug: Placebo |
| BI 425809 dose 4 | Experimental | Drug: BI 425809 dose 4, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 425809 dose 1 | Drug | BI 425809 dose 1 |
| BI 425809 dose 2 | Drug | BI 425809 dose 2 |
| BI 425809 dose 3 | Drug | BI 425809 dose 3 |
| BI 425809 dose 4 | Drug | BI 425809 dose 4 |
| Placebo | Drug | BI 425809 dose 1, BI 425809 dose 2, BI 425809 dose 3, BI 425809 dose 4, Placebo |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36709275Wunderlich G, Blahova Z, Garcia M, Jessen F. Efficacy and safety of the novel GlyT1 inhibitor BI 425809 in Alzheimer's dementia: a randomized controlled trial. Alzheimers Res Ther. 2023 Jan 28;15(1):24. doi: 10.1186/s13195-023-01163-3.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
95 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 425809 dose 1, BI 425809 dose 2 and BI 425809 dose 3 in people with Alzheimer Disease, run by Boehringer Ingelheim at 95 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States, Japan, France, Germany, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.