Dyslipidemia Clinical Trial
— EBBINGHAUSOfficial title:
A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients With Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial
Verified date | December 2017 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.
Status | Completed |
Enrollment | 1974 |
Est. completion date | November 11, 2016 |
Est. primary completion date | November 11, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Randomized into Study 20110118 (FOURIER; NCT01764633) Exclusion Criteria: - Current or known past diagnosis of dementia or mild cognitive impairment (MCI) |
Country | Name | City | State |
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Australia | Research Site | Adelaide | South Australia |
Australia | Research Site | Ashford | South Australia |
Australia | Research Site | Auchenflower | Queensland |
Australia | Research Site | Box Hill | Victoria |
Australia | Research Site | Epping | Victoria |
Australia | Research Site | Fullarton | South Australia |
Australia | Research Site | Geelong | Victoria |
Australia | Research Site | Hobart | Tasmania |
Australia | Research Site | Woden | Australian Capital Territory |
Belgium | Research Site | Aalst | |
Belgium | Research Site | Bonheiden | |
Belgium | Research Site | Brussels | |
Belgium | Research Site | Brussels | |
Belgium | Research Site | Gozee | |
Belgium | Research Site | Ieper | |
Belgium | Research Site | La Louvière | |
Belgium | Research Site | Liege | |
Belgium | Research Site | Liège | |
Canada | Research Site | Chicoutimi | Quebec |
Canada | Research Site | Gatineau | Quebec |
Canada | Research Site | London | Ontario |
Canada | Research Site | Newmarket | Ontario |
Canada | Research Site | Newmarket | Ontario |
Canada | Research Site | Peterborough | Ontario |
Canada | Research Site | Pointe-Claire | Quebec |
Canada | Research Site | Quebec | |
Canada | Research Site | Sarnia | Ontario |
Canada | Research Site | St Jean sur Richelieu | Quebec |
Canada | Research Site | St-Jérôme | Quebec |
Canada | Research Site | St. Johns | Newfoundland and Labrador |
Czechia | Research Site | Beroun | |
Czechia | Research Site | Bilovec | |
Czechia | Research Site | Brandys nad Labem | |
Czechia | Research Site | Brno | |
Czechia | Research Site | Brno | |
Czechia | Research Site | Brno | |
Czechia | Research Site | Chomutov | |
Czechia | Research Site | Havlickuv Brod | |
Czechia | Research Site | Hodonin | |
Czechia | Research Site | Klatovy IV | |
Czechia | Research Site | Liberec | |
Czechia | Research Site | Litomysl | |
Czechia | Research Site | Mohelnice | |
Czechia | Research Site | Olomouc | |
Czechia | Research Site | Ostrava - Vitkovice | |
Czechia | Research Site | Pardubice | |
Czechia | Research Site | Praha 10 | |
Czechia | Research Site | Praha 2 | |
Czechia | Research Site | Praha 3 | |
Czechia | Research Site | Praha 4 | |
Czechia | Research Site | Praha 5 - Smichov | |
Czechia | Research Site | Prerov | |
Czechia | Research Site | Uherske Hradiste | |
Denmark | Research Site | Aalborg | |
Denmark | Research Site | Ballerup | |
Denmark | Research Site | Esbjerg | |
Denmark | Research Site | Hvidovre | |
Denmark | Research Site | København S | |
Denmark | Research Site | Køge | |
Denmark | Research Site | Vejle | |
Estonia | Research Site | Paide | |
Estonia | Research Site | Tallinn | |
Estonia | Research Site | Tallinn | |
Estonia | Research Site | Tallinn | |
Finland | Research Site | Helsinki | |
Finland | Research Site | Helsinki | |
Finland | Research Site | Jyväskylä | |
Finland | Research Site | Kuopio | |
Finland | Research Site | Oulu | |
Finland | Research Site | OYS | |
Finland | Research Site | Tampere | |
Finland | Research Site | Turku | |
France | Research Site | Besançon Cedex | |
France | Research Site | Le Coudray | |
France | Research Site | Montepellier Cedex | |
France | Research Site | Nantes Cedex 1 | |
France | Research Site | Paris | |
France | Research Site | Pessac Cedex | |
France | Research Site | Toulouse Cedex 9 | |
Germany | Research Site | Bad Krozingen | |
Germany | Research Site | Berlin | |
Germany | Research Site | Berlin | |
Germany | Research Site | Berlin | |
Germany | Research Site | Bochum | |
Germany | Research Site | Dresden | |
Germany | Research Site | Frankfurt am Main | |
Germany | Research Site | Hamburg | |
Germany | Research Site | Hannover | |
Germany | Research Site | Köln | |
Germany | Research Site | Leipzig | |
Germany | Research Site | Stuttgart | |
Germany | Research Site | Witten | |
Germany | Research Site | Wuppertal | |
Greece | Research Site | Alexandroupoli | |
Greece | Research Site | Athens | |
Greece | Research Site | Athens | |
Greece | Research Site | Athens | |
Greece | Research Site | Ioannina | |
Greece | Research Site | Larissa | |
Greece | Research Site | Piraeus | |
Hong Kong | Research Site | Hong Kong | |
Hungary | Research Site | Bekescsaba | |
Hungary | Research Site | Berettyoujfalu | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Nyiregyhaza | |
Hungary | Research Site | Pecs | |
Hungary | Research Site | Szeged | |
Hungary | Research Site | Szekszard | |
Hungary | Research Site | Szikszo | |
Hungary | Research Site | Zalaegerszeg | |
Italy | Research Site | Pavia | |
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Japan | Research Site | Osaka-shi | Osaka |
Japan | Research Site | Osaka-shi | Osaka |
Japan | Research Site | Saga-shi | Saga |
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Japan | Research Site | Sapporo-shi | Hokkaido |
Japan | Research Site | Shimajiri-gun | Okinawa |
Japan | Research Site | Toride-shi | Ibaraki |
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Japan | Research Site | Tsukuba-city | Ibaraki |
Japan | Research Site | Urasoe-shi | Okinawa |
Latvia | Research Site | Daugavpils | |
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Latvia | Research Site | Ogre | |
Latvia | Research Site | Ogre | |
Latvia | Research Site | Riga | |
Latvia | Research Site | Riga | |
Lithuania | Research Site | Vilnius | |
Malaysia | Research Site | Kuala Lumpur | Wilayah Persekutuan |
Malaysia | Research Site | Kuala Lumpur | |
Netherlands | Research Site | Arnhem | |
Netherlands | Research Site | Ede | |
Netherlands | Research Site | Eindhoven | |
Netherlands | Research Site | Hoorn | |
Netherlands | Research Site | Uden | |
New Zealand | Research Site | Christchurch | |
New Zealand | Research Site | Tauranga | |
Norway | Research Site | Ålesund | |
Norway | Research Site | Hamar | |
Norway | Research Site | Lierskogen | |
Norway | Research Site | Oslo | |
Norway | Research Site | Skedsmokorset | |
Norway | Research Site | Skien | |
Norway | Research Site | Stavanger | |
Poland | Research Site | Gdansk | |
Poland | Research Site | Gdynia | |
Poland | Research Site | Gdynia | |
Poland | Research Site | Katowice | |
Poland | Research Site | Katowice | |
Poland | Research Site | Katowice | |
Poland | Research Site | Kielce | |
Poland | Research Site | Krakow | |
Poland | Research Site | Krakow | |
Poland | Research Site | Lodz | |
Poland | Research Site | Lodz | |
Poland | Research Site | Lublin | |
Poland | Research Site | Olsztyn | |
Poland | Research Site | Poznan | |
Poland | Research Site | Pulawy | |
Poland | Research Site | Ruda Slaska | |
Poland | Research Site | Staszow | |
Poland | Research Site | Swidnik | |
Poland | Research Site | Tarnow | |
Poland | Research Site | Torun | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Wloclawek | |
Poland | Research Site | Wroclaw | |
Poland | Research Site | Wroclaw | |
Poland | Research Site | Wroclaw | |
Poland | Research Site | Zamosc | |
Portugal | Research Site | Almada | |
Portugal | Research Site | Carnaxide | |
Portugal | Research Site | Coimbra | |
Portugal | Research Site | Covilha | |
Russian Federation | Research Site | Ekaterinburg | |
Russian Federation | Research Site | Ivanovo | |
Russian Federation | Research Site | Izhevsk | |
Russian Federation | Research Site | Kemerovo | |
Russian Federation | Research Site | Kemerovo | |
Russian Federation | Research Site | Kirov | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Nizhniy Novgorod | |
Russian Federation | Research Site | Novosibirsk | |
Russian Federation | Research Site | Omsk | |
Russian Federation | Research Site | Pushkin | |
Russian Federation | Research Site | Saint Petersburg | |
Russian Federation | Research Site | Saint Petersburg | |
Russian Federation | Research Site | Saint-Petersburg | |
Russian Federation | Research Site | Saratov | |
Russian Federation | Research Site | St. Petersburg | |
Russian Federation | Research Site | Tomsk | |
Slovakia | Research Site | Bardejov | |
Slovakia | Research Site | Brezno | |
Slovakia | Research Site | Kosice | |
Slovakia | Research Site | Lucenec | |
Slovakia | Research Site | Moldava nad Bodvou | |
Slovakia | Research Site | Nove Zamky | |
Slovakia | Research Site | Rimavska Sobota | |
Slovakia | Research Site | Roznava | |
Slovakia | Research Site | Snina | |
Slovakia | Research Site | Svidnik | |
Slovakia | Research Site | Trencin | |
Slovakia | Research Site | Trnava | |
South Africa | Research Site | Cape Town | |
South Africa | Research Site | Centurion | Gauteng |
South Africa | Research Site | Johannesburg | Gauteng |
South Africa | Research Site | Johannesburg | Gauteng |
South Africa | Research Site | Kempton Park | |
South Africa | Research Site | Paarl | Western Cape |
South Africa | Research Site | Parow | Western Cape |
South Africa | Research Site | Pretoria | Gauteng |
South Africa | Research Site | Pretoria west | Gauteng |
South Africa | Research Site | Somerset West | Western Cape |
South Africa | Research Site | Worcester | Western Cape |
Spain | Research Site | Galdakao | País Vasco |
Spain | Research Site | L'Hospitalet de Llobregat | Cataluña |
Spain | Research Site | Madrid | |
Spain | Research Site | Santiago de Compostela | Galicia |
Spain | Research Site | Valencia | Comunidad Valenciana |
Spain | Research Site | Vigo | Galicia |
Spain | Research Site | Zaragoza | Aragón |
Sweden | Research Site | Helsingborg | |
Sweden | Research Site | Linköping | |
Sweden | Research Site | Lund | |
Sweden | Research Site | Stockholm | |
Sweden | Research Site | Stockholm | |
Sweden | Research Site | Uddevalla | |
Sweden | Research Site | Västerås | |
Turkey | Research Site | Adana | |
Turkey | Research Site | Ankara | |
Turkey | Research Site | Gaziantep | |
Turkey | Research Site | Istanbul | |
Turkey | Research Site | Istanbul | |
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United Kingdom | Research Site | Belfast | |
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Lead Sponsor | Collaborator |
---|---|
Amgen |
United States, Australia, Belgium, Canada, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, United Kingdom,
Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Cognitive Function in a Randomized Trial of Evolocumab. N Engl J Med. 2017 Aug 17;377(7):633-643. doi: 10.1056/NEJMoa1701131. — View Citation
Giugliano RP, Mach F, Zavitz K, Kurtz C, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Design and rationale of the EBBINGHAUS trial: A phase 3, double-blind, placebo-controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid-lowering therapy-A cognitive study of patients enrolled in the FOURIER trial. Clin Cardiol. 2017 Feb;40(2):59-65. doi: 10.1002/clc.22678. Epub 2017 Feb 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score | Assessments were performed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) test assesses the cognitive domain of executive function (high-level thinking and decision making). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found. The SWM strategy index of executive function represented the number of times a subject began a search with a different box. The Z score represents the standardized measure of how far an individual subject deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported. |
Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | |
Secondary | Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score | Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) between-errors test assesses the cognitive domain of working memory (holding material in mind while that material is being actively processed). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found. The SWM between-errors score is the number of times that a patient revisited a box in which a token had previously been found. The Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported. |
Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | |
Secondary | Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score | The CANTAB PAL test assesses visuospatial episodic memory (storing/retrieving information by associating an event with a time and place). Boxes on the screen opened up one at a time to reveal a number of patterns. Participants were asked to remember the location of each pattern. After all the boxes had been opened, each pattern was then shown in the center of the screen in a randomized order, and the patient should touch the box where they think each pattern was hidden. The PAL total errors adjusted comprised the number of errors committed by a patient plus an adjustment for the estimated number of errors the patient would have made on any stages that were not reached. Z score represents the standardized measure of how far an individual patient deviates from the study cohort average at baseline. A higher Z score indicated better performance. The mean change from baseline averaged across all the visits is reported. |
Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | |
Secondary | Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score | Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Reaction Time (RTI) test assessed the cognitive domain of psychomotor speed (detecting and responding to a stimulus). Participants held down a button until a spot appeared in 1 of 5 circles on the screen. As soon as possible after the spot flashed up, the patient lifted their finger from the button and touched the circle in which the spot appeared. The RTI median 5-choice reaction time was the median duration between the onset of the stimulus and the release of the button. Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported. | Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). |
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Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
|
Phase 3 |