Clinical trial NCT02079246: Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 1463
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX
timeFrame: Baseline II (start of OLEX, week 0) to end of OLEX (week 28)
measure: Number of TEAEs in the OLEX-MEM
timeFrame: From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)
Secondary outcomes:
measure: Change in Cognition
timeFrame: Baseline II (start of OLEX, Week 0) to Week 28
measure: Clinical Global Impression Score
timeFrame: Week 28
measure: Change in Daily Functioning
timeFrame: Baseline II (start of OLEX, Week 0) to Week 28
measure: Change in Behavioural Disturbance
timeFrame: Baseline II (start of OLEX, Week 0) to Week 28
measure: Change in Cognitive Aspects of Mental Function
timeFrame: Baseline II (start of OLEX, Week 0) to Week 28
measure: Change in Cognitive Aspects of Mental Function
timeFrame: Baseline III (start of OLEX-MEM, Week 28) to Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: US027
state: Alabama
city: Phoenix
country: United States
facility: US012
state: Arizona
city: Phoenix
country: United States
facility: US338
state: Arizona
city: Little Rock
country: United States
facility: US024
state: Arkansas
city: Carlsbad
country: United States
facility: US351
state: California
city: Costa Mesa
country: United States
facility: US346
state: California
city: Fullerton
country: United States
facility: US327
state: California
city: Imperial
country: United States
facility: US023
state: California
city: Long Beach
country: United States
facility: US045
state: California
city: Redlands
country: United States
facility: US307
state: California
city: San Francisco
country: United States
facility: US058
state: California
city: Santa Ana
country: United States
facility: US018
state: California
city: Santa Rosa
country: United States
facility: US301
state: California
city: Bradenton
country: United States
facility: US021
state: Florida
city: Brooksville
country: United States
facility: US050
state: Florida
city: Delray Beach
country: United States
facility: US308
state: Florida
city: Hallandale Beach
country: United States
facility: US320
state: Florida
city: Hialeah
country: United States
facility: US347
state: Florida
city: Lake Worth
country: United States
facility: US340
state: Florida
city: Miami
country: United States
facility: US303
state: Florida
city: Miami
country: United States
facility: US313
state: Florida
city: Orange City
country: United States
facility: US345
state: Florida
city: Orlando
country: United States
facility: US019
state: Florida
city: Palm Beach Gardens
country: United States
facility: US309
state: Florida
city: Port Charlotte
country: United States
facility: US038
state: Florida
city: Sunrise
country: United States
facility: US302
state: Florida
city: Atlanta
country: United States
facility: US304
state: Georgia
city: Augusta
country: United States
facility: US360
state: Georgia
city: Kailua
country: United States
facility: US048
state: Hawaii
city: Chicago
country: United States
facility: US030
state: Illinois
city: Indianapolis
country: United States
facility: US040
state: Indiana
city: Lake Charles
country: United States
facility: US334
state: Louisiana
city: Freeport
country: United States
facility: US036
state: Maine
city: Boston
country: United States
facility: US344
state: Massachusetts
city: Kalamazoo
country: United States
facility: US035
state: Michigan
city: Saint Paul
country: United States
facility: US310
state: Minnesota
city: Flowood
country: United States
facility: US041
state: Mississippi
city: Hattiesburg
country: United States
facility: US321
state: Mississippi
city: Manchester
country: United States
facility: US339
state: New Jersey
city: Princeton
country: United States
facility: US046
state: New Jersey
city: Toms River
country: United States
facility: US028
state: New Jersey
city: Toms River
country: United States
facility: US044
state: New Jersey
city: Manhasset
country: United States
facility: US014
state: New York
city: New York
country: United States
facility: US029
state: New York
city: Staten Island
country: United States
facility: US312
state: New York
city: Charlotte
country: United States
facility: US316
state: North Carolina
city: Winston-Salem
country: United States
facility: US336
state: North Carolina
city: Centerville
country: United States
facility: US007
state: Ohio
city: Cincinnati
country: United States
facility: US323
state: Ohio
city: Columbus
country: United States
facility: US006
state: Ohio
city: Columbus
country: United States
facility: US306
state: Ohio
city: Lakewood
country: United States
facility: US352
state: Ohio
city: Oklahoma City
country: United States
facility: US333
state: Oklahoma
city: Portland
country: United States
facility: US026
state: Oregon
city: Jenkintown
country: United States
facility: US057
state: Pennsylvania
city: Pittsburgh
country: United States
facility: US324
state: Pennsylvania
city: Pittsburgh
country: United States
facility: US341
state: Pennsylvania
city: Port Royal
country: United States
facility: US319
state: South Carolina
city: Cordova
country: United States
facility: US356
state: Tennessee
city: Fort Worth
country: United States
facility: US343
state: Texas
city: Houston
country: United States
facility: US354
state: Texas
city: Arlington
country: United States
facility: US047
state: Virginia
city: Madison
country: United States
facility: US025
state: Wisconsin
city: Milwaukee
country: United States
facility: US004
state: Wisconsin
city: Banfield
country: Argentina
facility: AR303
city: Buenos Aires
country: Argentina
facility: AR007
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: AR003
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: AR304
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: AR308
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: AR311
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: AR313
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: AR314
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: AR312
city: Cordoba
country: Argentina
facility: AR009
city: Cordoba
country: Argentina
facility: AR307
city: Cordoba
country: Argentina
facility: AR309
city: Godoy Cruz
country: Argentina
facility: AR305
city: Mar del Plata
country: Argentina
facility: AR004
city: Mendoza
country: Argentina
facility: AR005
city: Mendoza
country: Argentina
facility: AR008
city: Mendoza
country: Argentina
facility: AR310
city: Rosario
country: Argentina
facility: AR010
city: Santa Fe
country: Argentina
facility: AR302
city: Santiago del Estero
country: Argentina
facility: AR306
city: Brugge
country: Belgium
facility: BE003
city: Brussels
country: Belgium
facility: BE002
city: Bruxelles
country: Belgium
facility: BE004
city: Leuven
country: Belgium
facility: BE005
city: Roeselare
country: Belgium
facility: BE001
city: Curitiba
country: Brazil
facility: BR307
city: Curitiba
country: Brazil
facility: BR309
city: Porto Alegre
country: Brazil
facility: BR303
city: Rio de Janeiro
country: Brazil
facility: BR301
city: Rio de Janeiro
country: Brazil
facility: BR306
city: Sao Paulo
country: Brazil
facility: BR302
city: São Paulo
country: Brazil
facility: BR304
city: São Paulo
country: Brazil
facility: BR308
city: Plovdiv
country: Bulgaria
facility: BG005
city: Sofia
country: Bulgaria
facility: BG001
city: Sofia
country: Bulgaria
facility: BG002
city: Sofia
country: Bulgaria
facility: BG003
city: Sofia
country: Bulgaria
facility: BG004
city: Sofia
country: Bulgaria
facility: BG006
city: Gatineau
country: Canada
facility: CA002
city: Gatineau
country: Canada
facility: CA309
city: Halifax
country: Canada
facility: CA301
city: Kelowna
country: Canada
facility: CA302
city: London
country: Canada
facility: CA006
city: Montreal
country: Canada
facility: CA306
city: Newmarket
country: Canada
facility: CA008
city: Qubec
country: Canada
facility: CA304
city: Toronto
country: Canada
facility: CA001
city: Toronto
country: Canada
facility: CA305
city: Toronto
country: Canada
facility: CA308
city: Verdun
country: Canada
facility: CA307
city: Antofagasta
country: Chile
facility: CL004
city: Santiago
country: Chile
facility: CL002
city: Santiago
country: Chile
facility: CL003
city: Santiago
country: Chile
facility: CL005
city: Valdivia
country: Chile
facility: CL001
city: Zabok
country: Croatia
facility: HR304
city: Zagreb
country: Croatia
facility: HR301
city: Zagreb
country: Croatia
facility: HR302
city: Brno
country: Czechia
facility: CZ006
city: Chocen
country: Czechia
facility: CZ309
city: Hradec Kralove
country: Czechia
facility: CZ306
city: Kutna Hora
country: Czechia
facility: CZ007
city: Pardubice
country: Czechia
facility: CZ004
city: Praha 10 - Strasnice
country: Czechia
facility: CZ310
city: Praha 10
country: Czechia
facility: CZ003
city: Praha 10
country: Czechia
facility: CZ304
city: Praha 2
country: Czechia
facility: CZ001
city: Praha 6
country: Czechia
facility: CZ002
city: Praha 6
country: Czechia
facility: CZ301
city: Praha 6
country: Czechia
facility: CZ303
city: Rychnov nad Kneznou
country: Czechia
facility: CZ005
city: Aarhus N
country: Denmark
facility: DK003
city: Copenhagen
country: Denmark
facility: DK001
city: Tallinn
country: Estonia
facility: EE301
city: Tallin
country: Estonia
facility: EE303
city: Tartu
country: Estonia
facility: EE302
city: Kuopio
country: Finland
facility: FI302
city: Oulu
country: Finland
facility: FI303
city: Turku
country: Finland
facility: FI301
city: Besancon Cedex
country: France
facility: FR006
city: Bordeaux
country: France
facility: FR301
city: Bron cedex
country: France
facility: FR308
city: Elancourt
country: France
facility: FR309
city: Limoges
country: France
facility: FR008
city: Marseille cedex 5
country: France
facility: FR302
city: Nantes Cedex
country: France
facility: FR003
city: Nantes
country: France
facility: FR312
city: Nice
country: France
facility: FR303
city: Paris cedex 10
country: France
facility: FR005
city: Paris
country: France
facility: FR001
city: Paris
country: France
facility: FR311
city: Reims
country: France
facility: FR306
city: Rouen
country: France
facility: FR305
city: Saint Priest en Jarez
country: France
facility: FR004
city: Saint Priest en Jarez
country: France
facility: FR313
city: Toulouse
country: France
facility: FR002
city: Berlin
country: Germany
facility: DE002
city: Ellwangen
country: Germany
facility: DE006
city: Hannover
country: Germany
facility: DE005
city: Heidelberg
country: Germany
facility: DE007
city: Munchen
country: Germany
facility: DE009
city: Ulm
country: Germany
facility: DE008
city: Unterhaching
country: Germany
facility: DE004
city: Budapest
country: Hungary
facility: HU304
city: Budapest
country: Hungary
facility: HU305
city: Esztergom
country: Hungary
facility: HU301
city: Szeged
country: Hungary
facility: HU302
city: Haifa
country: Israel
facility: IL302
city: Holon
country: Israel
facility: IL303
city: Ramat Gan
country: Israel
facility: IL304
city: Ancona
country: Italy
facility: IT004
city: Brescia
country: Italy
facility: IT006
city: Brescia
country: Italy
facility: IT306
city: Brescia
country: Italy
facility: IT309
city: Cefalù
country: Italy
facility: IT313
city: Firenze
country: Italy
facility: IT002
city: Genova
country: Italy
facility: IT311
city: Lamezia Terme
country: Italy
facility: IT003
city: Milano
country: Italy
facility: IT001
city: Monza
country: Italy
facility: IT312
city: Palermo
country: Italy
facility: IT005
city: Palermo
country: Italy
facility: IT007
city: Perugia
country: Italy
facility: IT307
city: Pisa
country: Italy
facility: IT301
city: Roma
country: Italy
facility: IT305
city: Roma
country: Italy
facility: IT308
city: Torino
country: Italy
facility: IT304
city: Torrette
country: Italy
facility: IT310
city: Busan
country: Korea, Republic of
facility: KR303
city: Incheon
country: Korea, Republic of
facility: KR301
city: Seongnam-si
country: Korea, Republic of
facility: KR308
city: Seoul
country: Korea, Republic of
facility: KR302
city: Seoul
country: Korea, Republic of
facility: KR304
city: Seoul
country: Korea, Republic of
facility: KR305
city: Seoul
country: Korea, Republic of
facility: KR306
city: Seoul
country: Korea, Republic of
facility: KR307
city: Seoul
country: Korea, Republic of
facility: KR309
city: Kaunas
country: Lithuania
facility: LT302
city: Kaunas
country: Lithuania
facility: LT303
city: Vilnius
country: Lithuania
facility: LT301
city: Vilnius
country: Lithuania
facility: LT304
city: Bialystok
country: Poland
facility: PL301
city: Bydgoszcz
country: Poland
facility: PL304
city: Gdynia
country: Poland
facility: PL308
city: Gliwice
country: Poland
facility: PL004
city: Katowice
country: Poland
facility: PL007
city: Krakow
country: Poland
facility: PL309
city: Lodz
country: Poland
facility: PL302
city: Lubin
country: Poland
facility: PL310
city: Lublin
country: Poland
facility: PL306
city: Oswiecim
country: Poland
facility: PL307
city: Poznan
country: Poland
facility: PL303
city: Pozna
country: Poland
facility: PL005
city: Sopot
country: Poland
facility: PL006
city: Szczecin
country: Poland
facility: PL002
city: Szczecin
country: Poland
facility: PL311
city: Warszawa
country: Poland
facility: PL003
city: Wroclaw
country: Poland
facility: PL008
city: Amadora
country: Portugal
facility: PT301
city: Coimbra
country: Portugal
facility: PT302
city: Bucharest
country: Romania
facility: RO002
city: Târgu-Mureş
country: Romania
facility: RO001
city: Bloemfontein
country: South Africa
facility: ZA003
city: Cape Town
country: South Africa
facility: ZA006
city: Cape Town
country: South Africa
facility: ZA007
city: George
country: South Africa
facility: ZA004
city: Pretoria
country: South Africa
facility: ZA001
city: Rosebank
country: South Africa
facility: ZA002
city: Barcelona
country: Spain
facility: ES006
city: Manresa
country: Spain
facility: ES005
city: Salamanca
country: Spain
facility: ES004
city: San Sebastian
country: Spain
facility: ES001
city: San Vicente del Raspeig
country: Spain
facility: ES002
city: Santiago de Compostela
country: Spain
facility: ES003
city: Kaohsiung
country: Taiwan
facility: TW301
city: Kaohsiung
country: Taiwan
facility: TW302
city: Tainan
country: Taiwan
facility: TW303
city: Dnipropetrovsk
country: Ukraine
facility: UA008
city: Kherson
country: Ukraine
facility: UA006
city: Kyiv
country: Ukraine
facility: UA005
city: Kyiv
country: Ukraine
facility: UA007
city: Lviv
country: Ukraine
facility: UA001
city: Amersham
country: United Kingdom
facility: GB307
city: Glasgow
country: United Kingdom
facility: GB301
city: London
country: United Kingdom
facility: GB303
city: London
country: United Kingdom
facility: GB308
city: London
country: United Kingdom
facility: GB310
city: Plymouth
country: United Kingdom
facility: GB306
city: Plymouth
country: United Kingdom
facility: GB311
city: Prescot
country: United Kingdom
facility: GB309
city: Preston
country: United Kingdom
facility: GB305
city: Southampton
country: United Kingdom
facility: GB304
city: Swindon
country: United Kingdom
facility: GB302
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: