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.
Verified date | October 2020 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States, Austria, Canada, Finland, France, Germany, Greece, Hungary, Italy, Japan, Norway, Poland, Spain, United Kingdom,
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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