Early Alzheimer´s Disease Clinical Trial
Official title:
A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE Plus)
| Verified date | April 2024 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken. Participants must have a study partner, who is willing to take part in the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period. A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.
| Status | Active, not recruiting |
| Enrollment | 1840 |
| Est. completion date | October 23, 2026 |
| Est. primary completion date | September 19, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 55 Years to 85 Years |
| Eligibility | Inclusion Criteria: - Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent. - MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria. - CDR (Clinical Dementia Rating) global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home & hobbies, community affairs) Or CDR global score of 1.0 - RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed memory index score of below or equal to 85 - MMSE (Mini-Mental State Examination) greater than or equal to 22 - Amyloid positivity established with either amyloid PET (positron emission tomography), CSF (cerebrospinal fluid) Aß1-42 or CSF Aß1-42/Aß1-40. - If receiving an approved Alzheimer's disease treatment (such as acetylcholinesterase inhibitors, memantine or aducanumab) the dose must have been stable for at least 3 months prior to screening and should not be changed during the trial unless medically necessary. Exclusion Criteria: - Brain MRI (or CT) scan suggestive of clinically significant structural CNS (central nervous system) disease confirmed by central read (e.g. cerebral large-vessel disease [large vessel (cortical) infarcts greater than10 mm in diameter], prior macro-haemorrhage [greater than1 cm^3], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus). - Brain MRI (magnetic resonance imaging) (or CT) scan suggestive of strategic infarcts defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic infarcts confirmed by central read. - Evidence of a relevant neurological disorder other than MCI or mild dementia of the Alzheimer's type at screening, including but not limited to Parkinson's disease, Lewy body disease, frontotemporal dementia of any type, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive supranuclear palsy, neurosyphilis, HIV (human immunodeficiency virus), learning disability, intellectual disability, hypoxic cerebral damage, or significant head trauma with loss of consciousness that led to persistent cognitive deficits. - Evidence of a clinically relevant or unstable psychiatric disorder, based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, including schizophrenia or other psychotic disorder, or bipolar disorder. A subject with a history of major depression who has not had an episode in the last 24 months before the day of screening and is considered in remission or whose depression is controlled with treatment can be included in the trial per investigator's judgement. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Italiano | Buenos Aires | |
| Argentina | Instituto de Investigaciones Metabolicas (IDIM) | Buenos Aires | |
| Argentina | Clínica Nuestra Señora de las Nieves | Caba | |
| Argentina | FLENI | Caba | |
| Argentina | Neurosite | Caba | |
| Argentina | Instituto Privado Kremer | Córdoba | |
| Argentina | Fundación Scherbovsky | Mendoza | |
| Australia | The Prince Charles Hospital | Chermside | Queensland |
| Australia | St Vincent's Hospital | Darlinghurst | New South Wales |
| Australia | Medical and Cognitive Research Unit - Austin Health | Ivanhoe | Victoria |
| Australia | Southern Neurology | Kogarah | New South Wales |
| Australia | KaRa Institute of Neurological Disease Pty Ltd | Macquarie Park | New South Wales |
| Australia | HammondCare | Malvern | Victoria |
| Australia | Alzheimer's Research Australia | Nedlands | Western Australia |
| Australia | Hunter New England Local Health District - Neuropsychiatry | Waratah | New South Wales |
| Austria | LKH-Univ. Kliniken Innsbruck | Innsbruck | |
| Austria | Medizinische Univ. Innsbruck | Innsbruck | |
| Austria | Univ. Klinik für Neurologie | Salzburg | |
| Austria | Medizinische Universität Wien | Wien | |
| Belgium | UZA - UZ Antwerpen - Department of Neurology | Edegem | |
| Belgium | UZ Gent - Neurologie | Gent | |
| Belgium | AZ Groeninge - Kortrijk - Neurologie | Kortrijk | |
| Belgium | UZ Leuven - Geheugenkliniek | Leuven | |
| Belgium | Clinique CHC MontLégia - Service Neurologie | Liège | |
| Brazil | Hospital das Clínicas - Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais |
| Brazil | L2 IP Instituto de Pesquisas Clinicas Ltda | Brasília | Distrito Federal |
| Brazil | Instituto de Neurologia de Curitiba | Curitiba | Parana |
| Brazil | Clinica Clinilive Ltda | Maringa | Parana |
| Brazil | Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. | Porto Alegre | Rio Grande Do Sul |
| Brazil | Centro de Psiquiatria Sandra Rushel | Rio de Janeiro | |
| Brazil | BR Trials - Ensaios Clínicos e Consultoria Ltda. | São Paulo | Sao Paulo |
| Brazil | CPQuali Pesquisa Clínica Ltda | São Paulo | Sao Paulo |
| Bulgaria | "MHATNP "Sv. Naum"" EAD | Sofia | |
| Bulgaria | "UMHAT "Aleksandrovska", Neurology clinic | Sofia | |
| Bulgaria | DCC Sv. Vrach and Sv. Sv. Kuzma and Damyan | Sofia | |
| Bulgaria | MMA, MHAT-Sofia, Neurology clinic | Sofia | |
| Canada | Recherchs Neuro-Hippocampe Inc | Gatineau | Quebec |
| Canada | MoCA Research Innovation Inc | Greenfield-Park | Quebec |
| Canada | True North Clinical Research - Halifax | Halifax | Nova Scotia |
| Canada | OCT Research ULC (dba Okanagan Clinical Trials) | Kelowna | British Columbia |
| Canada | Douglas Hosp Res Ctr | Montréal | Quebec |
| Canada | True North Clinical Research - New Minas | New Minas | Nova Scotia |
| Canada | Kawartha Centre Redefining Healthy Aging | Peterborough | Ontario |
| Canada | CHU de Quebec-Universite Laval | Québec | Quebec |
| Canada | Diex Recherche Sherbrooke Inc. | Sherbrooke | Quebec |
| Canada | Centricity Research LMC | Toronto | Ontario |
| Canada | Memory Program | Toronto | Ontario |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Canada | University Health Network | Toronto | Ontario |
| Canada | Island Health (Research and Capacity Building) | Victoria | British Columbia |
| Canada | Medical Arts Health Research Group | West Vancouver | British Columbia |
| China | Baogang Hospital of Inner Mongolia-Neurology | Baotou | Inner Mongolia |
| China | Beijing An Ding Hospital Capital Medical University | Beijing | Beijing |
| China | Beijing Chao-Yang Hospital, Capital Medical University-Neuro | Beijing | Beijing |
| China | Beijing Friendship Hospital, Capital Medical University-Neur | Beijing | Beijing |
| China | Beijing Hospital-Neurology | Beijing | Beijing |
| China | Beijing Huilongguan Hospital | Beijing | Beijing |
| China | Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing |
| China | Peking Union Medical College Hospital-Neurology | Beijing | Beijing |
| China | Peking University Sixth Hospital | Beijing | Beijing |
| China | Xuanwu Hospital Capital Medical University-Neurology | Beijing | Beijing |
| China | The first Bethune Hospital of Jilin University, Neurology | Changchun | Jilin |
| China | Xiangya Hospital Central South University-Neurology | Changsha | Hunan |
| China | West China Hospital,Sichuan University-Mental health center | Chengdu | Sichuan |
| China | The First Affiliated Hosp of Chongqing Medical Univer. | Chongqing | Chongqing |
| China | Fujian Medical University Union Hospital-Neurology | Fuzhou | Fujian |
| China | 2nd affiliated hospital of Guangzhou Medical University | Guangzhou | Guangdong |
| China | Guangzhou First People's Hospital-Neurology | Guangzhou | Guangdong |
| China | Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Neurol | Guangzhou | Guangdong |
| China | The first Hospital of Zhejiang University-Neurology | Hangzhou | Zhejiang |
| China | The Second Affiliated Hospital of Nanchang University-Neurol | Nanchang | Jiangxi |
| China | Nanjing Brain Hospital | Nanjing | Jiangsu |
| China | Nanjing Drum Tower Hospital-Neurology | Nanjing | Jiangsu |
| China | Zhongda Hospital Southeast University-Neurology | Nanjing | Jiangsu |
| China | Huashan Hospital Affiliated Fudan University | Shanghai | Shanghai |
| China | Shanghai 6th People's Hosp. Affili. to SHJT Univer-Neurology | Shanghai | Shanghai |
| China | Shanghai Dongfang Hospital | Shanghai | Shanghai |
| China | General Hospital of Tianjin Medical University-Neurology | Tianjin | Tianjin |
| China | Tianjin Huanhu Hospital | Tianjin | Tianjin |
| China | Wuxi Mental Health Center | Wuxi | Jiangsu |
| China | Qinghai Provincial People's Hospital-Geriatrics | Xining | Qinghai |
| China | Northern Jiangsu People's Hospital-Neurology | Yangzhou | Jiangsu |
| China | Henan Provincial People's Hospital-Neurology | Zhengzhou | Henan |
| Croatia | KBC Zagreb, Klinika za neurologiju | Zagreb | |
| Croatia | Poliklinika Bonifarm | Zagreb | |
| Croatia | Poliklinika Solmed | Zagreb | Grad Zagreb |
| Czechia | Neuro Health Centrum s.r.o. | Brno-Lisen | |
| Czechia | AGE Centrum | Olomouc | |
| Czechia | AD71 s.r.o. | Praha 10 | |
| Czechia | Neuropsychiatrie | Praha 6 Dejvice | |
| Czechia | Vestra Clinics s.r.o. | Rychnov nad Kneznou | |
| Denmark | Aarhus Universitetshospital | Aarhus N | |
| Denmark | Rigshospitalet - afsnit 8015 | København Ø | |
| Denmark | Sjællands Universitetshospital_Roskilde | Roskilde | |
| Finland | CRST Helsinki | Helsinki | |
| Finland | Aivotutkimusyksikkö | Kuopio | |
| Finland | CRST Turku | Turku | |
| France | Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin | Bordeaux | |
| France | Hospices Civils de Lyon-Hopital Pierre Wertheimer | Bron | |
| France | Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage | Dijon | |
| France | Assistance Publique Hopitaux de Marseille-Hopital de La Timone-1 | Marseille | |
| France | Centre Hospitalier Universitaire de Nice-Institut Claude Pompidou | Nice | |
| France | Aphp-Hopital La Pitie Salpetriere-3 | Paris | |
| France | Aphp-Hopital Lariboisiere-1 | Paris | |
| France | Centre Hospitalier Universitaire Reims-Hopital Maison Blanche | Reims cedex | |
| France | Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-2 | Saint Herblain | |
| France | Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre-2 | Strasbourg cedex 2 | |
| France | Centre Hospitalier Universitaire de Toulouse-Hopital La Grave | Toulouse | |
| France | Hospices Civils de Lyon-Hopital Des Charpennes | Villeurbanne | |
| Germany | Universitätsklinikum Köln | Köln | |
| Germany | Universitätsklinikum Münster, Neurologie | Münster | |
| Greece | "Hygeia" General Hospital of Athens, Memory clinic | Athens | |
| Greece | Aiginitio Hospital, 1st Neurology Clinic | Athens | |
| Greece | Henry Dunant Hospital Center,2nd Neurological Department | Athens | |
| Greece | Naval Hospital of Athens | Athens | |
| Greece | University General Hospital of Athens "Attiko" | Chaidari, Athens | |
| Greece | AHEPA General University Hospital | Thessaloniki | |
| Greece | EUROMEDICA General Clinic of Thessaloniki,Neurology Dpt | Thessaloniki | |
| Hungary | Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft. | Budapest | |
| Hungary | Semmelweis Egyetem ÁOK | Budapest | |
| Hungary | DE Gyógyszerfejlesztési Koordinációs Központ Pszichiátria | Debrecen | |
| Hungary | DE Kenézy Gyula Campus, Pszichiátriai és Pszichoterápiai Klinika | Debrecen | |
| Hungary | Bugát Pál Kórház | Gyöngyös | |
| Hungary | Petz Aladar Megyei Korhaz | Gyor | |
| Hungary | Petz Aladar Megyei Oktato Korhaz | Gyor | |
| Hungary | Somogy Megyei Kaposi Mór Oktató Kórház | Kaposvár | |
| Hungary | Psychotech Kft. | Pécs | |
| Hungary | Belvárosi Egészségház Kft. | Zalaegerszeg | |
| Ireland | Mercer's Institute for Successful Aging | Dublin | |
| Ireland | St Vincent's University Hospital | Dublin | |
| Ireland | Tallaght University Hospital | Dublin | |
| Israel | The Stroke and Cognition Institute Rambam Medical Center | Haifa | |
| Israel | Cognitive Neurology Clinic, Rabin Campus, Beilinson Hospital | Petach Tikva | |
| Israel | Cognitive Neurology Sourasky Medical Center | Tel Aviv | |
| Israel | Chaim Sheba Medical Center, Geriatric Rehabilitation Center | Tel Hashomer, Ramat Gan | |
| Italy | AOU Ospedali Riuniti S.O.D | Ancona | |
| Italy | Azienda Ospedaliera Spedali Civili di Brescia | Brescia | |
| Italy | Università degli studi Gabriele D'Annunzio Chieti-Pescara | Chieti | |
| Italy | AOU Careggi Firenze | Firenze | |
| Italy | Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico | Milano | |
| Italy | IRCCS Ospedale San Raffaele Milano | Milano | |
| Italy | ASST Monza e Brianza Ospedale San Gerardo | Monza | |
| Italy | Ospedale Santa Maria della Misericordia | Perugia | |
| Italy | Fondazione Santa Lucia IRCCS | Roma | |
| Italy | Pol. Uni. Campus Biomedico UOC Neurologia | Roma | |
| Italy | Policlinico Tor Vergata | Roma | |
| Italy | Policlinico Universitario A.Gemelli Servizio Neuropsicologia | Roma | |
| Italy | AOU Città della Salute e della Scienza di Torino | Torino | |
| Japan | Iwaki Clinic_Psychosomatic medicine | Anan, Tokushima | |
| Japan | Yachiyo Hospital | Anjo-shi, Aichi | |
| Japan | Memory Clinic Ochanomizu | Bunkyo-ku, Tokyo | |
| Japan | Tokyo Medical And Dental University Hospital | Bunkyo-ku,Tokyo | |
| Japan | Kashiwado Hospital | Chib-shi, Chiba | |
| Japan | Enomoto Internal Medicine Clinic | Chofu-shi,Tokyo | |
| Japan | Shinozuka Hospital | Fujioka-Shi, Gunma | |
| Japan | P-one Clinic | Hachioji-shi, Tokyo | |
| Japan | National Hospital Organization Tenryu Hospital | Hamamatsu-shi, Shizuoka | |
| Japan | Hyogo Brain and Heart Center | Himeji-city, Hyogo | |
| Japan | Himeji Central Hospital Clinic | Himeji-shi, Hyogo | |
| Japan | Tsukazaki Hospital | Himeji-shi, Hyogo | |
| Japan | Hatsuta Neurology Clinic | Hirakata-Shi,Osaka | |
| Japan | Hiroshima Neurology Clinic | Hiroshima-shi, Hiroshima | |
| Japan | Imon Yukari Neurology Clinic | Hiroshima-shi, Hiroshima | |
| Japan | Nagamitsu Clinic | Hofu-shi, Yamaguchi | |
| Japan | Ina Central Hospital | Ina-shi, Nagano | |
| Japan | Kawasaki Saiwai Clinic_Internal Medicine | Kanagawa | |
| Japan | Kishiro Mental Clinic | Kawasaki-shi , Kanagawa | |
| Japan | Koukan Clinic | Kawasaki-shi, Kanagawa | |
| Japan | Teikyo University Hospital, Mizonokuchi_Kawasaki-shi, Kanagawa | Kawasaki-shi, Kanagawa | |
| Japan | Kobe University Hospital | Kobe-shi, Hyogo | |
| Japan | Kobe University Hospital_Kobe-shi, Hyogo | Kobe-shi, Hyogo | |
| Japan | National Center of Neurology and Psychiatry | Kodaira-shi, Tokyo | |
| Japan | Southern Tohoku Medical Clinic | Koriyama-shi, Fukushima | |
| Japan | Katayama Medical Clinic | Kurashiki-shi, Okayama | |
| Japan | Nozomi Memory Clinic | Mitaka-shi,Tokyo | |
| Japan | Kikukawa clinic | Nerima-ku, Tokyo | |
| Japan | General Rehabilitation Center · Midori Hospital | Niigata-shi, Niigata | |
| Japan | National Center for Geriatrics and Gerontology | Obu-shi, Aichi | |
| Japan | Okayama Kyokuto Hospital | Okayama-shi, Okayama | |
| Japan | Jichiidai Station Brain Clinic | Shimotsuke-shi, Tochigi | |
| Japan | Keio University Hospital | Shinjuku-ku, Tokyo | |
| Japan | Shizuoka City Shimizu Hospital_Neurology | Shizuoka-shi, Shizuoka | |
| Japan | Kagawa Prefectural Central Hospital_Takamatsu-shi, Kagawa | Takamatsu-shi, Kagawa | |
| Japan | Takatsuki General Hospital | Takatsuki-Shi, Osaka | |
| Japan | Saino Clinic | Tokorozawa-shi,Saitama | |
| Japan | Itsuki Hospital | Tokushima-shi, Tokushima | |
| Japan | Alzclinic Tokyo | Tokyo | |
| Japan | Juntendo Tokyo Koto Geriatric Medical Center | Tokyo | |
| Japan | Kurumi CLINIC | Tokyo | |
| Japan | Tokyo Center Clinic | Tokyo | |
| Japan | Tokyo Medical Univ. Hospital | Tokyo | |
| Japan | Memory Clinic Toride | Toride-shi, Ibaraki | |
| Japan | MI Clinic | Toyonaka-shi, Osaka | |
| Japan | Medical Corporation Midorikai Wako Hospital | Wako-shi, Saitama | |
| Korea, Republic of | Dong-A University Medical Center | Busan | |
| Korea, Republic of | Chungnam National University Hospital | Daejeon | |
| Korea, Republic of | Chonnam National University Hospital | Gwangju | |
| Korea, Republic of | Seoul National University Bundang Hospital | Gyeonggi-do | |
| Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
| Korea, Republic of | Inha University Hospital | Incheon | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Ewha Womans University Seoul Hospital | Seoul | |
| Korea, Republic of | Hanyang University Medical Center | Seoul | |
| Korea, Republic of | Konkuk University Medical Center | Seoul | |
| Korea, Republic of | Samsung Medical Center_Seoul | Seoul | |
| Netherlands | Amphia Ziekenhuis | Breda | |
| Netherlands | Brain Research Center | Den Bosch | |
| Netherlands | Radboudumc | Nijmegen | |
| Poland | Centrum Medyczne Neuromed | Bydgoszcz | |
| Poland | Centrum Zdrowia Psychicznego Biomed | Kielce | |
| Poland | Centrum Neurologii Klinicznej | Kraków | |
| Poland | Linden sp. z o.o. sp. k. | Kraków | Malopolskie |
| Poland | Szpital Uniwersytecki w Krakowie od. Neurologii | Kraków | |
| Poland | Nzoz Neuromed | Lublin | |
| Poland | INSTYTUT ZDROWIA DR BOCZARSKA-JEDYNAKSp. z o.o. Sp. k. | Oswiecim | |
| Poland | NZOZ NEURO - KARD Ilkowski i Partnerzy Sp. Part. Lekarzy | Poznan | |
| Poland | Osrodek Alzheimerowski Sp. z o.o. | Scinawa | |
| Poland | Centrum Medyczne SENIOR | Sopot | |
| Poland | Centrum Medyczne Neuro Protect | Warszawa | |
| Poland | NZOZ Wroclawskie Centrum Alzheimerowskie | Wroclaw | |
| Portugal | Hospital de Braga | Braga | |
| Portugal | Centro Hospitalar e Universitário de Coimbra | Coimbra | |
| Portugal | Hospital da Senhora da Oliveira - Guimarães | Guimarães | |
| Portugal | Centro Hospitalar Lisboa Ocidental | Lisboa | |
| Portugal | Hospital Beatriz Ângelo | Loures | |
| Portugal | Unidade Local de Saúde de Matosinhos | Matosinhos | |
| Portugal | Centro Hospitalar do Porto, E.P.E | Porto | |
| Portugal | Campus Neurologico Senior | Torres Vedras | |
| Romania | Spitalul Clinic Cai Ferate Constanta | Constanta | |
| Romania | Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta | Constanta | |
| Romania | Aria Clinic SRL | Sibiu | |
| Russian Federation | Joint Stock Company "Medical technologies" | Ekaterinburg | |
| Russian Federation | SAHI SR "Sverdlovsk Regional Clinical Psychiatric Hospital" | Ekaterinburg | |
| Russian Federation | FSAEI 1st Moscow Federal Med University na Sechenov | Moscow | |
| Russian Federation | Pirogov Russian National Research Medical University MoH | Moscow | |
| Russian Federation | RMAPE | Moscow | |
| Russian Federation | Ezramed Clinic Llc | Omsk | |
| Russian Federation | Research Center for Treatment and Rehabilitation "Phoenix" | Rostov-on-Don | |
| Russian Federation | N.-E. State Medical University n.a. Mechnikov | Saint Petersburg | |
| Russian Federation | Psychiatric hospital of st. Nicholas the wonderworker | Saint Petersburg | |
| Russian Federation | Center of Clinica Trials "Nebbiolo" | Tomsk | |
| Russian Federation | LLC "Clinic Stolet" | Tomsk | |
| Russian Federation | National medical holdiNational medical holding "Medstandard" | Ufa | |
| Serbia | Neurology clinic, University Clinical Center of Serbia | Belgrade | |
| Serbia | Special Hospital for Psychiatric Disorders "Kovin" | Kovin | |
| Serbia | University clinical center of Vojvodina, Neurology clinic | Novi Sad | |
| Slovakia | I. neurologicka klinika LF UK a UNB | Bratislava | |
| Slovakia | Psychiatricka klinika LF UK a UNB | Bratislava | |
| Slovakia | Neurologicka klinika UPJS LF a UNLP | Kosice | |
| Slovakia | NEURES, neurologicka ambulancia | Krompachy | |
| Slovakia | Crystal Comfort s.r.o. | Vranov nad Toplou | |
| Slovenia | UKC Ljubljana, Department of Neurology | Ljubljana | |
| Slovenia | UKC Maribor - neurology | Maribor | |
| South Africa | IATROS International | Bloemfontein | Free State |
| South Africa | ACF Neurological service | Cape Town | Western Cape |
| South Africa | Cape Trial Centre | Cape Town | Western Cape |
| South Africa | Flexivest Fourteen Research Centre | Cape Town | Western Cape |
| South Africa | Excellentis Clinical Trial Consultants | George | Eastern Cape |
| South Africa | Dr Stanley Lipschitz Clinic Inc | Johannesburg | Gauteng |
| South Africa | Denmar Psychiatric Hospital | Pretoria | Gauteng |
| Spain | Fundación ACE | Barcelona | |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital 12 de Octubre | Madrid | |
| Spain | Hospital Quirón | Pozuelo de Alarcon | |
| Spain | Hospital Universitari General de Catalunya | Sant Cugat del Vallès | |
| Spain | Hospital Universitario Doctor Peset | Valencia | |
| Sweden | Minnesmottagning specialiserad Malmö | Malmö | |
| Sweden | Karolinska Universitetssjukhuset, Huddinge | Stockholm | |
| Sweden | Geriatriskt centrum, Umeå | Umeå | |
| Switzerland | Spitalzentrum Biel | Biel-Bienne | |
| Switzerland | Centre de la Mémoire | Genève | |
| Switzerland | Centre Leenaards de la mémoire CHUV | Lausanne | |
| Switzerland | Klinik für Neurologie Kantonsspital St.Gallen | St. Gallen | |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
| Taiwan | Chang Gung Memorial Hospital - Kaoshiung Branch | Kaohsiung City | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | National Cheng Kung University Hospital | Tainan City | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| Taiwan | Taipei Veteran General Hospital | Taipei | |
| Taiwan | Chang Gung Memorial Hospital Linkou | Taoyuan City | |
| Turkey | Hacettepe University Medical Faculty Hospital | Altindag/Ankara | |
| Turkey | Eskisehir Osmangazi University Saglik Uygulama ve Arastirma | Eskisehir | |
| Turkey | Istanbul University Medical Faculty Neurology Department | Istanbul | |
| Turkey | Izmir Economics University Medical Point Hospital Neurology D | Izmir | |
| Turkey | Ondokuz Mayis University Saglik Uygulama ve Arastirma Merkez | Samsun | |
| Ukraine | Medical Center 'Neiron' | Kharkiv | |
| Ukraine | Odesa Regional Medical Center for Mental Health | Odesa | |
| United Kingdom | Royal Cornhill Hospital | Aberdeen | |
| United Kingdom | RICE - The Research Institute for the Care of Older People | Bath | |
| United Kingdom | Dementia Research Unit, | Crowborough | |
| United Kingdom | Ninewells Hospital | Dundee | |
| United Kingdom | Western General Hospital | Edinburgh | |
| United Kingdom | Fritchie Centre | Gloucestershire | |
| United Kingdom | Imperial College London | London | |
| United Kingdom | St George's Hospital | London | |
| United Kingdom | St Pancras Clinical Research | London | |
| United Kingdom | Greater Manchester Mental Health NHS Foundation Trust | Manchester | |
| United Kingdom | Glasgow Memory Clinic | Motherwell | |
| United Kingdom | Newcastle University | Newcastle Upon Tyne | |
| United Kingdom | Warneford Hospital | Oxford | |
| United Kingdom | Moorgreen Hospital | Southampton | |
| United Kingdom | Kings Hill Research Centre | Swindon | |
| United States | Advanced Research Center, Inc. | Anaheim | California |
| United States | JEM Research Institute | Atlantis | Florida |
| United States | Texas Diabetes & Endocrinology | Austin | Texas |
| United States | Visionary Investigators Network | Aventura | Florida |
| United States | Northern Light Eastern Maine Medical Center | Bangor | Maine |
| United States | Mountain Neurological Research Center, Inc. | Basalt | Colorado |
| United States | Insight Clinical Trials LLC | Beachwood | Ohio |
| United States | Memory Clinic, Inc | Bennington | Vermont |
| United States | NeuroScience Research Center, LLC | Canton | Ohio |
| United States | New Hope Clinical Research | Charlotte | North Carolina |
| United States | Nuvance Health, Associtd Neuro | Danbury | Connecticut |
| United States | iResearch Atlanta, LLC | Decatur | Georgia |
| United States | Brain Matters Research | Delray Beach | Florida |
| United States | Denver Neurological Research | Denver | Colorado |
| United States | Mile High Research Center | Denver | Colorado |
| United States | Integrated Neurology Services | Falls Church | Virginia |
| United States | Neuropsychiatric Research Cent | Fort Myers | Florida |
| United States | Finlay Medical Research Group | Greenacres City | Florida |
| United States | Hattiesburg Clinic | Hattiesburg | Mississippi |
| United States | Galiz Research | Hialeah | Florida |
| United States | Indago Research & Health Center Inc. | Hialeah | Florida |
| United States | Hawaii Neuroscience, Memory Disorders Center | Honolulu | Hawaii |
| United States | Balyor College of Medicine | Houston | Texas |
| United States | Univ Of Texas Hlth Science Cntr | Houston | Texas |
| United States | Josephson Wallack Munshower | Indianapolis | Indiana |
| United States | Mt. Olympus Medical Research | Katy | Texas |
| United States | Booth Gardner Parkinson's Cre | Kirkland | Washington |
| United States | Genesis Neuroscience Clinic | Knoxville | Tennessee |
| United States | Neurological Assoc Long Island | Lake Success | New York |
| United States | Cleveland Clinic_Lakewood | Lakewood | Ohio |
| United States | Wr-Crcn, Llc | Las Vegas | Nevada |
| United States | University of Kentucky_Lexington_0 | Lexington | Kentucky |
| United States | Torrance Clin Res Inst, Inc. | Lomita | California |
| United States | ASCLEPES Research Centers, | Long Beach | California |
| United States | K2 Medical Research, Maitland | Maitland | Florida |
| United States | Feinstein Institute for Medical Research | Manhasset | New York |
| United States | AMC Research, LLC | Matthews | North Carolina |
| United States | Velocity Clinical Research | Meridian | Idaho |
| United States | Velocity Clinical Research, Meridian | Meridian | Idaho |
| United States | Central Miami Medical Institute | Miami | Florida |
| United States | Hlth Cr Family Rehab & Res Ctr | Miami | Florida |
| United States | IMIC, Inc- Medical Research | Miami | Florida |
| United States | Novel Clinical Research Center, LLC | Miami | Florida |
| United States | Premier Clin Res Inst, Inc. | Miami | Florida |
| United States | Premier Clinical Research Institute, Inc. | Miami | Florida |
| United States | The Neurology Research Group | Miami | Florida |
| United States | Visionary Inv Ntwrk_Miami | Miami | Florida |
| United States | Patient First MD,clinical Trials | Middletown | New Jersey |
| United States | Aqualane Clinical Research | Naples | Florida |
| United States | Vanderbilt Medical Center | Nashville | Tennessee |
| United States | Suncoast Clinical Research, Inc._New Port Richey | New Port Richey | Florida |
| United States | Research Center for Clinical Studies, Inc | Norwalk | Connecticut |
| United States | K2 Medical Research - Winter Garden | Ocoee | Florida |
| United States | Advanced Research Consultants, Inc. | Palm Beach Gardens | Florida |
| United States | Well Care Medical Center | Panorama City | California |
| United States | Cedars-Sinai Medical Center | Pasadena | California |
| United States | Banner Alzheimer's Institute | Phoenix | Arizona |
| United States | Coastal Neurology | Port Royal | South Carolina |
| United States | Neural Net Research, LLC | Portland | Oregon |
| United States | Summit Research Network Oregon Inc. | Portland | Oregon |
| United States | HealthPartners Center for Memory and Aging | Saint Paul | Minnesota |
| United States | Glenn Biggs Inst-Alzhm Neuro | San Antonio | Texas |
| United States | Sharp Neurocog Res Ctr | San Diego | California |
| United States | Syrentis Clinical Research | Santa Ana | California |
| United States | Intercoastal Medical Group | Sarasota | Florida |
| United States | Harborview Medical Center | Seattle | Washington |
| United States | Calfornia Neurosc Resrch Med | Sherman Oaks | California |
| United States | Richmond Behavioral Associates | Staten Island | New York |
| United States | Brain Matters Resrch Kane Cntr | Stuart | Florida |
| United States | Shirzadi Shahin, MD | Sugar Land | Texas |
| United States | Palmetto Clinical Research | Summerville | South Carolina |
| United States | Banner Sun Health Research Institute | Sun City | Arizona |
| United States | SUNY Upstate Medical University_Syracuse | Syracuse | New York |
| United States | Axiom Clinical Research of Florida | Tampa | Florida |
| United States | Stedman Clinical Trials LLC | Tampa | Florida |
| United States | Advanced Memory Research Institute of NJ | Toms River | New Jersey |
| United States | Cotton-O'Neil Clinical Research Center | Topeka | Kansas |
| United States | Central States Research, LLC | Tulsa | Oklahoma |
| United States | Conquest Research | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score | Score on scale (0 to 18) Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease: Cognitive domains: memory, orientation, and judgement and problem solving Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of the six domains. The CDR-Sum of Boxes (CDR-SB) score will be derived by adding the individual scores of the six domains at a given time point. The total CDR-SB score ranges from 0 to 18 with higher scores representing greater impairment. |
From baseline (week 0) to week 104 | |
| Secondary | Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for MCI (ADCS-ADLMCI) score | Score on scale (0 to 53). An interview-based assessment of information provided by the study partner (informant). The total scores based on 18 items on the scale range from 0 to 53 with lower scores representing greater impairment. | From baseline (week 0) to week 104 | |
| Secondary | Time to progression to dementia (CDR global greater than or equal to 1.0) among subjects with MCI (CDR global equal to 0.5) at baseline | Week(s) | From baseline (week 0) to week 104 | |
| Secondary | Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score | Score on scale (0 to 85) Measures the severity of cognitive impairment in various domains including memory, language, orientation, praxis and executive function. The total scores on the scale range from 0 to 85 with higher scores representing greater impairment. | From baseline (week 0) to week 104 | |
| Secondary | Change in the Montreal Cognitive Assessment (MoCA) score | Score on scale (0 to 30) The assessment includes 8 domains of cognitive function with total scores ranging from 0 to 30 and lower scores indicating greater impairment. | From baseline (week 0) to week 104 | |
| Secondary | Change in the Alzheimer's Disease Composite Score (ADCOMS) | Score on scale (0 to 1.97) The ADCOMS is a composite clinical outcome comprising 4 items from the ADAS-Cog-13, 2 items from the MMSE and all 6 items from the CDR-SB.32 The total scores on the scale range from 0 to 1.97 with higher scores indicating greater impairment. | From baseline (week 0) to week 104 | |
| Secondary | Change in the Mini-Mental State Examination (MMSE) score | Score on scale (0 to 30) The MMSE measures orientation, attention, memory, language and visuo-spatial function. The total scores on the scale range from 0 to 30 with lower scores indicating greater impairment. | From baseline (week 0) to week 104 | |
| Secondary | Change in the 10-item Neuropsychiatric Inventory (NPI) score | 104 Score on scale (0 to 120) The 10-item scale assesses symptoms including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability and aberrant motor activity. For each domain the frequency (4-point scale) and severity (3-point scale) of symptoms is reported. The score for each domain is calculated by multiplying the frequency and severity score. The total 10-item NPI score is 0 to 120 with higher scores indicating a greater symptomatology. | From baseline (week 0) to week 104 | |
| Secondary | Time to progression in disease stage based on global CDR score | Week(s) | From baseline (week 0) to week 104 | |
| Secondary | Number of treatment emergent adverse events (TEAEs) | Number of events | From baseline (week 0) to week 104 | |
| Secondary | Change in high sensitivity C-reactive protein level | Ratio | From baseline (week 0) to week 104 | |
| Secondary | Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and allcause death | Week(s) | From baseline (week 0) to week 104 | |
| Secondary | Time to first occurrence of stroke | Weeks | From baseline (week 0) to week 104 | |
| Secondary | Change in the EQ-5D-5L proxy score | Score The EQ-5D-5L descriptive system comprises mobility, self-care, usual activities, pain/discomfort and anxiety/depression with five response levels each (no problems, slight problems, moderate problems, severe problems, unable to /extreme problems). The EQ-5D-5L proxy version 1 (the study partner is asked to rate how he/she [the proxy] would rate the subject´s health) will be used in this trial. | From baseline (week 0) to week 104 | |
| Secondary | Extension phase: Change in the CDR-SB score | Score on scale (0 to 18) Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease: Cognitive domains: memory, orientation, and judgement and problem solving Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of the six domains. The CDR-Sum of Boxes (CDR-SB) score will be derived by adding the individual scores of the six domains at a given time point. The total CDR-SB score ranges from 0 to 18 with higher scores representing greater impairment. |
From baseline (week 0) to week 156 | |
| Secondary | Extension phase: Change in the ADCS-ADL-MCI score | Score on scale (0 to 53) An interview-based assessment of information provided by the study partner (informant). The total scores based on 18 items on the scale range from 0 to 53 with lower scores representing greater impairment. | From baseline (week 0) to week 156 | |
| Secondary | Extension phase: Time to progression to dementia (CDR global greater than or equal to 1.0) among subjects with MCI (CDR global equal to 0.5) at baseline | Week(s) | From baseline (week 0) to week 156 |