Clinical trial NCT01955161: Study of 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: 2013-10-07
Enrollment: 933
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 30 mg/day or 60 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 to Week 24
Secondary outcomes:
measure: Change in Daily Functioning
timeFrame: Baseline to Week 24
measure: Change in Global Impression
timeFrame: Baseline to Week 24
measure: Change in Behavioural Disturbance
timeFrame: Baseline to Week 24
measure: Change in Individual Behavioural Disturbance Items
timeFrame: Baseline to 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 to Week 24
measure: Clinical Improvement
timeFrame: Week 24
measure: Clinical Worsening
timeFrame: Week 24
measure: Change in Cognitive Aspects of Mental Function
timeFrame: Baseline to Week 24
measure: Change in Health-related Quality of Life (EQ-5D) Utility Score
timeFrame: Baseline to Week 24
measure: Change in Health-related Quality of Life (EQ-5D VAS)
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: US027
state: Alabama
city: Phoenix
country: United States
facility: US012
state: Arizona
city: Little Rock
country: United States
facility: US024
state: Arkansas
city: Glendale
country: United States
facility: US053
state: California
city: Imperial
country: United States
facility: US023
state: California
city: La Jolla
country: United States
facility: US015
state: California
city: Long Beach
country: United States
facility: US045
state: California
city: Los Angeles
country: United States
facility: US002
state: California
city: San Francisco
country: United States
facility: US058
state: California
city: Santa Ana
country: United States
facility: US018
state: California
city: Denver
country: United States
facility: US060
state: Colorado
city: Boca Raton
country: United States
facility: US042
state: Florida
city: Bradenton
country: United States
facility: US021
state: Florida
city: Brooksville
country: United States
facility: US050
state: Florida
city: Orlando
country: United States
facility: US019
state: Florida
city: Port Charlotte
country: United States
facility: US038
state: Florida
city: West Palm Beach
country: United States
facility: US001
state: Florida
city: Atlanta
country: United States
facility: US020
state: Georgia
city: Kailua
country: United States
facility: US048
state: Hawaii
city: Chicago
country: United States
facility: US030
state: Illinois
city: Joliet
country: United States
facility: US051
state: Illinois
city: Indianapolis
country: United States
facility: US040
state: Indiana
city: Freeport
country: United States
facility: US036
state: Maine
city: Newton
country: United States
facility: US032
state: Massachusetts
city: Kalamazoo
country: United States
facility: US035
state: Michigan
city: Flowood
country: United States
facility: US041
state: Mississippi
city: Saint Louis
country: United States
facility: US054
state: Missouri
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: Albany
country: United States
facility: US049
state: New York
city: Amherst
country: United States
facility: US010
state: New York
city: Manhasset
country: United States
facility: US014
state: New York
city: New York
country: United States
facility: US008
state: New York
city: New York
country: United States
facility: US029
state: New York
city: New York
country: United States
facility: US056
state: New York
city: Orangeburg
country: United States
facility: US037
state: New York
city: Staten Island
country: United States
facility: US043
state: New York
city: Centerville
country: United States
facility: US007
state: Ohio
city: Columbus
country: United States
facility: US006
state: Ohio
city: Edmond
country: United States
facility: US052
state: Oklahoma
city: Portland
country: United States
facility: US026
state: Oregon
city: Jenkintown
country: United States
facility: US057
state: Pennsylvania
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: Buenos Aires
country: Argentina
facility: AR002
city: Buenos Aires
country: Argentina
facility: AR003
city: Buenos Aires
country: Argentina
facility: AR006
city: Buenos Aires
country: Argentina
facility: AR007
city: Cordoba
country: Argentina
facility: AR009
city: Mar del Plata
country: Argentina
facility: AR004
city: Mendoza
country: Argentina
facility: AR005
city: Mendoza
country: Argentina
facility: AR008
city: Rosario
country: Argentina
facility: AR010
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: Thuin
country: Belgium
facility: BE006
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: Varna
country: Bulgaria
facility: BG007
city: Gatineau
country: Canada
facility: CA002
city: London
country: Canada
facility: CA006
city: Newmarket
country: Canada
facility: CA008
city: Toronto
country: Canada
facility: CA001
city: Toronto
country: Canada
facility: CA004
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: Brno
country: Czechia
facility: CZ006
city: Kutna Hora
country: Czechia
facility: CZ007
city: Pardubice
country: Czechia
facility: CZ004
city: Praha 10
country: Czechia
facility: CZ003
city: Praha 2
country: Czechia
facility: CZ001
city: Praha 6
country: Czechia
facility: CZ002
city: Rychnov nad Kneznou
country: Czechia
facility: CZ005
city: Aarhus N
country: Denmark
facility: DK003
city: Copenhagen
country: Denmark
facility: DK001
city: Odense C
country: Denmark
facility: DK002
city: Besancon Cedex
country: France
facility: FR006
city: Limoges Cedex1
country: France
facility: FR008
city: Nantes Cedex
country: France
facility: FR003
city: Paris cedex 10
country: France
facility: FR005
city: Paris
country: France
facility: FR001
city: Saint Etienne Cedex 2
country: France
facility: FR004
city: Toulouse
country: France
facility: FR002
city: Berlin
country: Germany
facility: DE002
city: Ellwangen
country: Germany
facility: DE006
city: Günzburg
country: Germany
facility: DE010
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: Ancona
country: Italy
facility: IT004
city: Brescia
country: Italy
facility: IT006
city: Firenze
country: Italy
facility: IT002
city: Genoa
country: Italy
facility: IT005
city: Lamezia Terme
country: Italy
facility: IT003
city: Milano
country: Italy
facility: IT001
city: Palermo
country: Italy
facility: IT007
city: Gliwice
country: Poland
facility: PL004
city: Katowice
country: Poland
facility: PL007
city: Poznan
country: Poland
facility: PL005
city: Sopot
country: Poland
facility: PL006
city: Szczecin
country: Poland
facility: PL002
city: Warszawa
country: Poland
facility: PL003
city: Wroclaw
country: Poland
facility: PL008
city: Bucharest
country: Romania
facility: RO002
city: Tirgu Mures
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: Port Elizabeth
country: South Africa
facility: ZA005
city: Pretoria
country: South Africa
facility: ZA001
city: Rosebank
country: South Africa
facility: ZA002
city: Alicante
country: Spain
facility: ES002
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: Santiago de Compostela
country: Spain
facility: ES003
city: Dnipropetrovsk
country: Ukraine
facility: UA008
city: Kherson,Vil. Stepanivka
country: Ukraine
facility: UA006
city: Kyiv
country: Ukraine
facility: UA005
city: Kyiv
country: Ukraine
facility: UA007
city: Lviv
country: Ukraine
facility: UA001
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.