Clinical trial NCT02006641: Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-12-10
Enrollment: 858
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

Detailed description: The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 10 mg/day or 30 mg/day as adjunctive therapy to donepezil 10 mg/day, and a 4-week safety follow-up period following study completion or withdrawal from treatment.

Eligibility criteria: Inclusion Criteria:

* The patient has a knowledgeable and reliable caregiver.
* The patient is an outpatient.
* The patient has probable AD.
* The patient has mild to moderate AD.
* Stable treatment with donepezil.
* The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.
* The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.

Exclusion Criteria:

* The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.
* The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.
* The patient has evidence of clinically significant disease.
* The patient's donepezil therapy is likely to be interrupted or discontinued during the study.
* The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change in Cognition
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change in Daily Functioning
timeFrame: Baseline and Week 24
measure: Change in Global Impression
timeFrame: Baseline and Week 24
measure: Change in Behavioural Disturbance
timeFrame: Baseline and Week 24
measure: Change in Individual Behavioural Disturbance Items
timeFrame: Baseline and Week 24
measure: Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline
timeFrame: Baseline and Week 24
measure: Number of Participants With Clinical Improvement
timeFrame: Week 24
measure: Number of Participants With Clinical Worsening
timeFrame: Week 24
measure: Change in Cognitive Aspects of Mental Function
timeFrame: Baseline and Week 24
measure: Change in Health-related Quality of Life (EQ-5D) Utility Score
timeFrame: Baseline and Week 24
measure: Change in Health-related Quality of Life (EQ-5D VAS)
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: US338
state: Arizona
city: Fayetteville
country: United States
facility: US342
state: Arkansas
city: Anaheim
country: United States
facility: US322
state: California
city: Carson
country: United States
facility: US305
state: California
city: Costa Mesa
country: United States
facility: US346
state: California
city: Fullerton
country: United States
facility: US327
state: California
city: Lomita
country: United States
facility: US315
state: California
city: Oceanside
country: United States
facility: US351
state: California
city: Redlands
country: United States
facility: US307
state: California
city: Santa Rosa
country: United States
facility: US301
state: California
city: New London
country: United States
facility: US337
state: Connecticut
city: Stamford
country: United States
facility: US332
state: Connecticut
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: Naples
country: United States
facility: US335
state: Florida
city: Orange City
country: United States
facility: US345
state: Florida
city: Palm Beach Gardens
country: United States
facility: US309
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: Decatur
country: United States
facility: US318
state: Georgia
city: Lake Charles
country: United States
facility: US334
state: Louisiana
city: Belmont
country: United States
facility: US350
state: Massachusetts
city: Boston
country: United States
facility: US344
state: Massachusetts
city: Saint Paul
country: United States
facility: US310
state: Minnesota
city: Hattiesburg
country: United States
facility: US321
state: Mississippi
city: Creve Coeur
country: United States
facility: US330
state: Missouri
city: Manchester
country: United States
facility: US339
state: New Jersey
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: Cincinnati
country: United States
facility: US323
state: Ohio
city: Cleveland
country: United States
facility: US349
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: Allentown
country: United States
facility: US314
state: Pennsylvania
city: Pittsburgh
country: United States
facility: US324
state: Pennsylvania
city: Pittsburgh
country: United States
facility: US341
state: Pennsylvania
city: Reading
country: United States
facility: US325
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: Banfield
country: Argentina
facility: AR303
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: AR301
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 Buenos Aires
country: Argentina
facility: AR315
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: AR312
city: Cordoba
country: Argentina
facility: AR309
city: Córdoba
country: Argentina
facility: AR307
city: Godoy Cruz
country: Argentina
facility: AR305
city: Mendoza
country: Argentina
facility: AR310
city: Santa Fe
country: Argentina
facility: AR302
city: Santiago del Estero
country: Argentina
facility: AR306
city: Curitiba
country: Brazil
facility: BR307
city: Curitiba
country: Brazil
facility: BR309
city: Rio de Janeiro
country: Brazil
facility: BR301
city: Rio de Janeiro
country: Brazil
facility: BR306
city: San Paolo
country: Brazil
facility: BR308
city: Halifax
country: Canada
facility: CA301
city: Kelowna
country: Canada
facility: CA302
city: Montreal
country: Canada
facility: CA306
city: Qubec
country: Canada
facility: CA304
city: Sherbrooke
country: Canada
facility: CA303
city: Toronto
country: Canada
facility: CA305
city: Zabok
country: Croatia
facility: HR304
city: Zagreb
country: Croatia
facility: HR301
city: Zagreb
country: Croatia
facility: HR302
city: Zagreb
country: Croatia
facility: HR303
city: Brno
country: Czechia
facility: CZ305
city: Chocen
country: Czechia
facility: CZ306
city: Chocen
country: Czechia
facility: CZ309
city: Pardubice
country: Czechia
facility: CZ308
city: Praha 10 - Strasnice
country: Czechia
facility: CZ310
city: Praha 10
country: Czechia
facility: CZ304
city: Praha 2
country: Czechia
facility: CZ307
city: Praha 6
country: Czechia
facility: CZ301
city: Praha 6
country: Czechia
facility: CZ303
city: Rychnov nad Kneznou
country: Czechia
facility: CZ302
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: Bordeaux
country: France
facility: FR301
city: Bron
country: France
facility: FR308
city: Colmar cedex
country: France
facility: FR307
city: Dijon
country: France
facility: FR304
city: Elancourt
country: France
facility: FR309
city: Marseille cedex 5
country: France
facility: FR302
city: Nice Cedex 1
country: France
facility: FR303
city: Reims
country: France
facility: FR306
city: Rouen
country: France
facility: FR305
city: Budapest
country: Hungary
facility: HU304
city: Budapest
country: Hungary
facility: HU305
city: Esztergom
country: Hungary
facility: HU301
city: Gyor
country: Hungary
facility: HU303
city: Szeged
country: Hungary
facility: HU302
city: Cork
country: Ireland
facility: IE301
city: Haifa
country: Israel
facility: IL302
city: Holon
country: Israel
facility: IL303
city: Ramat Gan
country: Israel
facility: IL304
city: Brescia
country: Italy
facility: IT306
city: Brescia
country: Italy
facility: IT309
city: Genova
country: Italy
facility: IT311
city: Monza
country: Italy
facility: IT312
city: Naples
country: Italy
facility: IT302
city: Palermo
country: Italy
facility: IT313
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: 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: Amadora
country: Portugal
facility: PT301
city: Coimbra
country: Portugal
facility: PT302
city: Kaohsiung
country: Taiwan
facility: TW301
city: Kaohsiung
country: Taiwan
facility: TW302
city: Taichung
country: Taiwan
facility: TW303
city: Taipei
country: Taiwan
facility: TW304
city: Taipei
country: Taiwan
facility: TW305
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: Plymouth
country: United Kingdom
facility: GB306
city: Preston
country: United Kingdom
facility: GB305
city: Southampton
country: United Kingdom
facility: GB304
city: Swindon
country: United Kingdom
facility: GB302
city: Warrington
country: United Kingdom
facility: GB309
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Ballard C, Atri A, Boneva N, Cummings JL, Frolich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.
citation: Cummings JL, Atri A, Ballard C, Boneva N, Frolich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2.
citation: Atri A, Frolich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.