Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease (STAR Extension)
August 9, 2018 updated by: H. Lundbeck A/S
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).
Study Overview
Detailed Description
This is an interventional, multi-national, multi-site, open-label extension study in patients with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or 14862A (NCT02006641).
Patients received 28-weeks of open-label treatment with idalopirdine 60 mg/day (option to reduce to 30 mg/day) as adjunctive treatment to donepezil. Approximately 100 patients, who had completed the initial 28-week period (OLEX), were included in a 24 week open-label treatment period with memantine (OLEX-MEM) that evaluated the safety and tolerability of concomitant memantine therapy in patients who were already on a stable treatment with idalopirdine and donepezil and for whom memantine treatment was clinically indicated.
Study Type
Interventional
Enrollment (Actual)
1463
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Banfield, Argentina
- AR303
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Buenos Aires, Argentina
- AR007
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Ciudad Autonoma Buenos Aires, Argentina
- AR003
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Ciudad Autonoma Buenos Aires, Argentina
- AR304
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Ciudad Autonoma Buenos Aires, Argentina
- AR308
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Ciudad Autonoma Buenos Aires, Argentina
- AR311
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Ciudad Autonoma Buenos Aires, Argentina
- AR313
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Ciudad Autonoma Buenos Aires, Argentina
- AR314
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Ciudad Autonoma de Buenos Aires, Argentina
- AR312
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Cordoba, Argentina
- AR009
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Cordoba, Argentina
- AR307
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Cordoba, Argentina
- AR309
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Godoy Cruz, Argentina
- AR305
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Mar del Plata, Argentina
- AR004
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Mendoza, Argentina
- AR005
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Mendoza, Argentina
- AR008
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Mendoza, Argentina
- AR310
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Rosario, Argentina
- AR010
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Santa Fe, Argentina
- AR302
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Santiago del Estero, Argentina
- AR306
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Brugge, Belgium
- BE003
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Brussels, Belgium
- BE002
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Bruxelles, Belgium
- BE004
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Leuven, Belgium
- BE005
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Roeselare, Belgium
- BE001
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Curitiba, Brazil
- BR307
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Curitiba, Brazil
- BR309
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Porto Alegre, Brazil
- BR303
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Rio de Janeiro, Brazil
- BR301
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Rio de Janeiro, Brazil
- BR306
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Sao Paulo, Brazil
- BR302
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São Paulo, Brazil
- BR304
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São Paulo, Brazil
- BR308
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Plovdiv, Bulgaria
- BG005
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Sofia, Bulgaria
- BG001
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Sofia, Bulgaria
- BG002
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Sofia, Bulgaria
- BG003
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Sofia, Bulgaria
- BG004
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Sofia, Bulgaria
- BG006
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Gatineau, Canada
- CA002
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Gatineau, Canada
- CA309
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Halifax, Canada
- CA301
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Kelowna, Canada
- CA302
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London, Canada
- CA006
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Montreal, Canada
- CA306
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Newmarket, Canada
- CA008
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Qubec, Canada
- CA304
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Toronto, Canada
- CA001
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Toronto, Canada
- CA305
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Toronto, Canada
- CA308
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Verdun, Canada
- CA307
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Antofagasta, Chile
- CL004
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Santiago, Chile
- CL002
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Santiago, Chile
- CL003
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Santiago, Chile
- CL005
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Valdivia, Chile
- CL001
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Zabok, Croatia
- HR304
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Zagreb, Croatia
- HR301
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Zagreb, Croatia
- HR302
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Brno, Czechia
- CZ006
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Chocen, Czechia
- CZ309
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Hradec Kralove, Czechia
- CZ306
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Kutna Hora, Czechia
- CZ007
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Pardubice, Czechia
- CZ004
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Praha 10, Czechia
- CZ003
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Praha 10, Czechia
- CZ304
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Praha 10 - Strasnice, Czechia
- CZ310
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Praha 2, Czechia
- CZ001
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Praha 6, Czechia
- CZ002
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Praha 6, Czechia
- CZ301
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Praha 6, Czechia
- CZ303
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Rychnov nad Kneznou, Czechia
- CZ005
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Aarhus N, Denmark
- DK003
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Copenhagen, Denmark
- DK001
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Tallin, Estonia
- EE303
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Tallinn, Estonia
- EE301
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Tartu, Estonia
- EE302
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Kuopio, Finland
- FI302
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Oulu, Finland
- FI303
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Turku, Finland
- FI301
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Besancon Cedex, France
- FR006
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Bordeaux, France
- FR301
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Bron cedex, France
- FR308
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Elancourt, France
- FR309
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Limoges, France
- FR008
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Marseille cedex 5, France
- FR302
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Nantes, France
- FR312
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Nantes Cedex, France
- FR003
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Nice, France
- FR303
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Paris, France
- FR001
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Paris, France
- FR311
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Paris cedex 10, France
- FR005
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Reims, France
- FR306
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Rouen, France
- FR305
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Saint Priest en Jarez, France
- FR004
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Saint Priest en Jarez, France
- FR313
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Toulouse, France
- FR002
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Berlin, Germany
- DE002
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Ellwangen, Germany
- DE006
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Hannover, Germany
- DE005
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Heidelberg, Germany
- DE007
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Munchen, Germany
- DE009
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Ulm, Germany
- DE008
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Unterhaching, Germany
- DE004
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Budapest, Hungary
- HU304
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Budapest, Hungary
- HU305
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Esztergom, Hungary
- HU301
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Szeged, Hungary
- HU302
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Haifa, Israel
- IL302
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Holon, Israel
- IL303
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Ramat Gan, Israel
- IL304
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Ancona, Italy
- IT004
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Brescia, Italy
- IT006
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Brescia, Italy
- IT306
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Brescia, Italy
- IT309
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Cefalù, Italy
- IT313
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Firenze, Italy
- IT002
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Genova, Italy
- IT311
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Lamezia Terme, Italy
- IT003
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Milano, Italy
- IT001
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Monza, Italy
- IT312
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Palermo, Italy
- IT005
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Palermo, Italy
- IT007
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Perugia, Italy
- IT307
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Pisa, Italy
- IT301
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Roma, Italy
- IT305
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Roma, Italy
- IT308
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Torino, Italy
- IT304
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Torrette, Italy
- IT310
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Busan, Korea, Republic of
- KR303
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Incheon, Korea, Republic of
- KR301
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Seongnam-si, Korea, Republic of
- KR308
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Seoul, Korea, Republic of
- KR302
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Seoul, Korea, Republic of
- KR304
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Seoul, Korea, Republic of
- KR305
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Seoul, Korea, Republic of
- KR306
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Seoul, Korea, Republic of
- KR307
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Seoul, Korea, Republic of
- KR309
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Kaunas, Lithuania
- LT302
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Kaunas, Lithuania
- LT303
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Vilnius, Lithuania
- LT301
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Vilnius, Lithuania
- LT304
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Bialystok, Poland
- PL301
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Bydgoszcz, Poland
- PL304
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Gdynia, Poland
- PL308
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Gliwice, Poland
- PL004
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Katowice, Poland
- PL007
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Krakow, Poland
- PL309
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Lodz, Poland
- PL302
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Lubin, Poland
- PL310
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Lublin, Poland
- PL306
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Oswiecim, Poland
- PL307
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Pozna, Poland
- PL005
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Poznan, Poland
- PL303
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Sopot, Poland
- PL006
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Szczecin, Poland
- PL002
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Szczecin, Poland
- PL311
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Warszawa, Poland
- PL003
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Wroclaw, Poland
- PL008
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Amadora, Portugal
- PT301
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Coimbra, Portugal
- PT302
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Bucharest, Romania
- RO002
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Târgu-Mureş, Romania
- RO001
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Bloemfontein, South Africa
- ZA003
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Cape Town, South Africa
- ZA006
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Cape Town, South Africa
- ZA007
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George, South Africa
- ZA004
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Pretoria, South Africa
- ZA001
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Rosebank, South Africa
- ZA002
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Barcelona, Spain
- ES006
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Manresa, Spain
- ES005
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Salamanca, Spain
- ES004
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San Sebastian, Spain
- ES001
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San Vicente del Raspeig, Spain
- ES002
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Santiago de Compostela, Spain
- ES003
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Kaohsiung, Taiwan
- TW301
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Kaohsiung, Taiwan
- TW302
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Tainan, Taiwan
- TW303
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Dnipropetrovsk, Ukraine
- UA008
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Kherson, Ukraine
- UA006
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Kyiv, Ukraine
- UA005
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Kyiv, Ukraine
- UA007
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Lviv, Ukraine
- UA001
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Amersham, United Kingdom
- GB307
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Glasgow, United Kingdom
- GB301
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London, United Kingdom
- GB303
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London, United Kingdom
- GB308
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London, United Kingdom
- GB310
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Plymouth, United Kingdom
- GB306
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Plymouth, United Kingdom
- GB311
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Prescot, United Kingdom
- GB309
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Preston, United Kingdom
- GB305
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Southampton, United Kingdom
- GB304
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Swindon, United Kingdom
- GB302
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Alabama
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Birmingham, Alabama, United States
- US027
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Arizona
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Phoenix, Arizona, United States
- US012
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Phoenix, Arizona, United States
- US338
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Arkansas
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Little Rock, Arkansas, United States
- US024
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California
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Carlsbad, California, United States
- US351
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Costa Mesa, California, United States
- US346
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Fullerton, California, United States
- US327
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Imperial, California, United States
- US023
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Long Beach, California, United States
- US045
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Redlands, California, United States
- US307
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San Francisco, California, United States
- US058
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Santa Ana, California, United States
- US018
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Santa Rosa, California, United States
- US301
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Florida
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Bradenton, Florida, United States
- US021
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Brooksville, Florida, United States
- US050
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Delray Beach, Florida, United States
- US308
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Hallandale Beach, Florida, United States
- US320
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Hialeah, Florida, United States
- US347
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Lake Worth, Florida, United States
- US340
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Miami, Florida, United States
- US303
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Miami, Florida, United States
- US313
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Orange City, Florida, United States
- US345
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Orlando, Florida, United States
- US019
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Palm Beach Gardens, Florida, United States
- US309
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Port Charlotte, Florida, United States
- US038
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Sunrise, Florida, United States
- US302
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Georgia
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Atlanta, Georgia, United States
- US304
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Augusta, Georgia, United States
- US360
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Hawaii
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Kailua, Hawaii, United States
- US048
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Illinois
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Chicago, Illinois, United States
- US030
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Indiana
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Indianapolis, Indiana, United States
- US040
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Louisiana
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Lake Charles, Louisiana, United States
- US334
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Maine
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Freeport, Maine, United States
- US036
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Massachusetts
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Boston, Massachusetts, United States
- US344
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Michigan
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Kalamazoo, Michigan, United States
- US035
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Minnesota
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Saint Paul, Minnesota, United States
- US310
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Mississippi
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Flowood, Mississippi, United States
- US041
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Hattiesburg, Mississippi, United States
- US321
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New Jersey
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Manchester, New Jersey, United States
- US339
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Princeton, New Jersey, United States
- US046
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Toms River, New Jersey, United States
- US028
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Toms River, New Jersey, United States
- US044
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New York
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Manhasset, New York, United States, 11030
- US014
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New York, New York, United States
- US029
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Staten Island, New York, United States
- US312
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North Carolina
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Charlotte, North Carolina, United States
- US316
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Winston-Salem, North Carolina, United States
- US336
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Ohio
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Centerville, Ohio, United States
- US007
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Cincinnati, Ohio, United States
- US323
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Columbus, Ohio, United States
- US006
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Columbus, Ohio, United States
- US306
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Lakewood, Ohio, United States
- US352
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Oklahoma
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Oklahoma City, Oklahoma, United States
- US333
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Oregon
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Portland, Oregon, United States
- US026
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Pennsylvania
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Jenkintown, Pennsylvania, United States
- US057
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Pittsburgh, Pennsylvania, United States
- US324
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Pittsburgh, Pennsylvania, United States
- US341
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South Carolina
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Port Royal, South Carolina, United States
- US319
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Tennessee
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Cordova, Tennessee, United States
- US356
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Texas
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Fort Worth, Texas, United States
- US343
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Houston, Texas, United States
- US354
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Virginia
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Arlington, Virginia, United States
- US047
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Wisconsin
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Madison, Wisconsin, United States
- US025
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Milwaukee, Wisconsin, United States
- US004
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
46 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641
For patients in the OLEX-MEM:
- The patient has completed Visit 6 (Week 28) of the OLEX.
- The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/SmPC/treatment guidelines.
Exclusion Criteria:
- The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator.
- The patient has experienced seizures before Completion Visit in the lead-in study.
- The patient has evidence of clinically significant disease.
- The patient's donepezil treatment is likely to be interrupted or discontinued during the study.
- The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).
Other protocol-defined inclusion and exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Idalopirdine (Lu AE58054) 60 mg
Idalopirdine 60 mg adjunct to 10 mg donepezil.
The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated.
The dose of donepezil was to be maintained throughout the study.
|
once daily, encapsulated tablets, orally
|
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Experimental: Idalopirdine 60 mg + memantine
Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose).
Memantine was administered to approximately 100 patients included in the OLEX-MEM.
The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated.
The dose of donepezil was to be maintained throughout the study.
The dose of memantine could be changed at any time throughout the study.
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once daily, encapsulated tablets, orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX
Time Frame: Baseline II (start of OLEX, week 0) to end of OLEX (week 28)
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A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.
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Baseline II (start of OLEX, week 0) to end of OLEX (week 28)
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Number of TEAEs in the OLEX-MEM
Time Frame: From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)
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A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM).
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From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cognition
Time Frame: Baseline II (start of OLEX, Week 0) to Week 28
|
Change from Baseline II to Week 28 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score.
The ADAS-cog is a 11-item neuropsychological test that assess the severity of cognitive impairment.
The items determine the patient's orientation, memory, language, and praxis.
Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).
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Baseline II (start of OLEX, Week 0) to Week 28
|
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Clinical Global Impression Score
Time Frame: Week 28
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Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 28.
The ADCS-CGIC is a semi-structured interview to assess clinically relevant changes in patients with AD.
The items determine cognition, behavior, social and daily functioning.
Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients).
The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening).
|
Week 28
|
|
Change in Daily Functioning
Time Frame: Baseline II (start of OLEX, Week 0) to Week 28
|
Change from Baseline II to Week 28 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.
The ADCS-ADL23 is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant).
Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity.
Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability).
|
Baseline II (start of OLEX, Week 0) to Week 28
|
|
Change in Behavioural Disturbance
Time Frame: Baseline II (start of OLEX, Week 0) to Week 28
|
Change from Baseline II to Week 28 in Neuropsychiatric Inventory (NPI) total score.
The NPI is a 12-item structured interview with a caregiver to assess behavioural disturbances.
The NPI comprises 10 behavioural and 2 neurovegetative items.
Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present).
Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]).
The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome).
|
Baseline II (start of OLEX, Week 0) to Week 28
|
|
Change in Cognitive Aspects of Mental Function
Time Frame: Baseline II (start of OLEX, Week 0) to Week 28
|
Change from Baseline II to Week 28 in Mini Mental State Examination (MMSE).
The MMSE is an 11-item test to assess the cognitive aspects of mental function.
The subtests assess orientation, memory, attention, language, and visual construction.
The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect).
Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).
|
Baseline II (start of OLEX, Week 0) to Week 28
|
|
Change in Cognitive Aspects of Mental Function
Time Frame: Baseline III (start of OLEX-MEM, Week 28) to Week 52
|
Change from Baseline III to Week 52 in Mini Mental State Examination (MMSE).
The MMSE is an 11-item test to assess the cognitive aspects of mental function.
The subtests assess orientation, memory, attention, language, and visual construction.
The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect).
Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).
|
Baseline III (start of OLEX-MEM, Week 28) to Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2014
Primary Completion (Actual)
July 6, 2017
Study Completion (Actual)
July 6, 2017
Study Registration Dates
First Submitted
February 28, 2014
First Submitted That Met QC Criteria
March 4, 2014
First Posted (Estimate)
March 5, 2014
Study Record Updates
Last Update Posted (Actual)
August 10, 2018
Last Update Submitted That Met QC Criteria
August 9, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14861B
- 2013-000001-23 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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