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Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease (STAR Extension)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Idalopirdine 60 mg
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • US027
  • US012
  • US338
  • US024
  • US351
  • US346
  • US327
  • US023
  • US045
  • US307
  • US058
  • US018
  • US301
  • US021
  • US050
  • US308
  • US320
  • US347
  • US340
  • US303
  • US313
  • US345
  • US019
  • US309
  • US038
  • US302
  • US304
  • US360
  • US048
  • US030
  • US040
  • US334
  • US036
  • US344
  • US035
  • US310
  • US041
  • US321
  • US339
  • US046
  • US028
  • US044
  • US014
  • US029
  • US312
  • US316
  • US336
  • US007
  • US323
  • US006
  • US306
  • US352
  • US333
  • US026
  • US057
  • US324
  • US341
  • US319
  • US356
  • US343
  • US354
  • US047
  • US025
  • US004
  • AR303
  • AR007
  • AR003
  • AR304
  • AR308
  • AR311
  • AR313
  • AR314
  • AR312
  • AR009
  • AR307
  • AR309
  • AR305
  • AR004
  • AR005
  • AR008
  • AR310
  • AR010
  • AR302
  • AR306
  • BE003
  • BE002
  • BE004
  • BE005
  • BE001
  • BR307
  • BR309
  • BR303
  • BR301
  • BR306
  • BR302
  • BR304
  • BR308
  • BG005
  • BG001
  • BG002
  • BG003
  • BG004
  • BG006
  • CA002
  • CA309
  • CA301
  • CA302
  • CA006
  • CA306
  • CA008
  • CA304
  • CA001
  • CA305
  • CA308
  • CA307
  • CL004
  • CL002
  • CL003
  • CL005
  • CL001
  • HR304
  • HR301
  • HR302
  • CZ006
  • CZ309
  • CZ306
  • CZ007
  • CZ004
  • CZ310
  • CZ003
  • CZ304
  • CZ001
  • CZ002
  • CZ301
  • CZ303
  • CZ005
  • DK003
  • DK001
  • EE301
  • EE303
  • EE302
  • FI302
  • FI303
  • FI301
  • FR006
  • FR301
  • FR308
  • FR309
  • FR008
  • FR302
  • FR003
  • FR312
  • FR303
  • FR005
  • FR001
  • FR311
  • FR306
  • FR305
  • FR004
  • FR313
  • FR002
  • DE002
  • DE006
  • DE005
  • DE007
  • DE009
  • DE008
  • DE004
  • HU304
  • HU305
  • HU301
  • HU302
  • IL302
  • IL303
  • IL304
  • IT004
  • IT006
  • IT306
  • IT309
  • IT313
  • IT002
  • IT311
  • IT003
  • IT001
  • IT312
  • IT005
  • IT007
  • IT307
  • IT301
  • IT305
  • IT308
  • IT304
  • IT310
  • KR303
  • KR301
  • KR308
  • KR302
  • KR304
  • KR305
  • KR306
  • KR307
  • KR309
  • LT302
  • LT303
  • LT301
  • LT304
  • PL301
  • PL304
  • PL308
  • PL004
  • PL007
  • PL309
  • PL302
  • PL310
  • PL306
  • PL307
  • PL303
  • PL005
  • PL006
  • PL002
  • PL311
  • PL003
  • PL008
  • PT301
  • PT302
  • RO002
  • RO001
  • ZA003
  • ZA006
  • ZA007
  • ZA004
  • ZA001
  • ZA002
  • ES006
  • ES005
  • ES004
  • ES001
  • ES002
  • ES003
  • TW301
  • TW302
  • TW303
  • UA008
  • UA006
  • UA005
  • UA007
  • UA001
  • GB307
  • GB301
  • GB303
  • GB308
  • GB310
  • GB306
  • GB311
  • GB309
  • GB305
  • GB304
  • GB302

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Idalopirdine (Lu AE58054) 60 mg

Idalopirdine 60 mg + memantine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.
Number of TEAEs in the OLEX-MEM
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM).

Secondary Outcome Measures

Change in Cognition
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).
Clinical Global Impression Score
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).
Change in Daily Functioning
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).
Change in Behavioural Disturbance
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).
Change in Cognitive Aspects of Mental Function
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).
Change in Cognitive Aspects of Mental Function
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).

Full Information

First Posted
February 28, 2014
Last Updated
August 9, 2018
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02079246
Brief Title
Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
Acronym
STAR Extension
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 7, 2014 (Actual)
Primary Completion Date
July 6, 2017 (Actual)
Study Completion Date
July 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1463 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Idalopirdine (Lu AE58054) 60 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Idalopirdine 60 mg + memantine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Idalopirdine 60 mg
Intervention Description
once daily, encapsulated tablets, orally
Primary Outcome Measure Information:
Title
Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX
Description
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.
Time Frame
Baseline II (start of OLEX, week 0) to end of OLEX (week 28)
Title
Number of TEAEs in the OLEX-MEM
Description
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM).
Time Frame
From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)
Secondary Outcome Measure Information:
Title
Change in Cognition
Description
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).
Time Frame
Baseline II (start of OLEX, Week 0) to Week 28
Title
Clinical Global Impression Score
Description
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).
Time Frame
Week 28
Title
Change in Daily Functioning
Description
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).
Time Frame
Baseline II (start of OLEX, Week 0) to Week 28
Title
Change in Behavioural Disturbance
Description
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).
Time Frame
Baseline II (start of OLEX, Week 0) to Week 28
Title
Change in Cognitive Aspects of Mental Function
Description
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).
Time Frame
Baseline II (start of OLEX, Week 0) to Week 28
Title
Change in Cognitive Aspects of Mental Function
Description
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).
Time Frame
Baseline III (start of OLEX-MEM, Week 28) to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US027
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
US012
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
US338
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
US024
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
US351
City
Carlsbad
State/Province
California
Country
United States
Facility Name
US346
City
Costa Mesa
State/Province
California
Country
United States
Facility Name
US327
City
Fullerton
State/Province
California
Country
United States
Facility Name
US023
City
Imperial
State/Province
California
Country
United States
Facility Name
US045
City
Long Beach
State/Province
California
Country
United States
Facility Name
US307
City
Redlands
State/Province
California
Country
United States
Facility Name
US058
City
San Francisco
State/Province
California
Country
United States
Facility Name
US018
City
Santa Ana
State/Province
California
Country
United States
Facility Name
US301
City
Santa Rosa
State/Province
California
Country
United States
Facility Name
US021
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
US050
City
Brooksville
State/Province
Florida
Country
United States
Facility Name
US308
City
Delray Beach
State/Province
Florida
Country
United States
Facility Name
US320
City
Hallandale Beach
State/Province
Florida
Country
United States
Facility Name
US347
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
US340
City
Lake Worth
State/Province
Florida
Country
United States
Facility Name
US303
City
Miami
State/Province
Florida
Country
United States
Facility Name
US313
City
Miami
State/Province
Florida
Country
United States
Facility Name
US345
City
Orange City
State/Province
Florida
Country
United States
Facility Name
US019
City
Orlando
State/Province
Florida
Country
United States
Facility Name
US309
City
Palm Beach Gardens
State/Province
Florida
Country
United States
Facility Name
US038
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
US302
City
Sunrise
State/Province
Florida
Country
United States
Facility Name
US304
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
US360
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
US048
City
Kailua
State/Province
Hawaii
Country
United States
Facility Name
US030
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
US040
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
US334
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
US036
City
Freeport
State/Province
Maine
Country
United States
Facility Name
US344
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
US035
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
US310
City
Saint Paul
State/Province
Minnesota
Country
United States
Facility Name
US041
City
Flowood
State/Province
Mississippi
Country
United States
Facility Name
US321
City
Hattiesburg
State/Province
Mississippi
Country
United States
Facility Name
US339
City
Manchester
State/Province
New Jersey
Country
United States
Facility Name
US046
City
Princeton
State/Province
New Jersey
Country
United States
Facility Name
US028
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
US044
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
US014
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
US029
City
New York
State/Province
New York
Country
United States
Facility Name
US312
City
Staten Island
State/Province
New York
Country
United States
Facility Name
US316
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
US336
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
US007
City
Centerville
State/Province
Ohio
Country
United States
Facility Name
US323
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
US006
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
US306
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
US352
City
Lakewood
State/Province
Ohio
Country
United States
Facility Name
US333
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
US026
City
Portland
State/Province
Oregon
Country
United States
Facility Name
US057
City
Jenkintown
State/Province
Pennsylvania
Country
United States
Facility Name
US324
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
US341
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
US319
City
Port Royal
State/Province
South Carolina
Country
United States
Facility Name
US356
City
Cordova
State/Province
Tennessee
Country
United States
Facility Name
US343
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
US354
City
Houston
State/Province
Texas
Country
United States
Facility Name
US047
City
Arlington
State/Province
Virginia
Country
United States
Facility Name
US025
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
US004
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
AR303
City
Banfield
Country
Argentina
Facility Name
AR007
City
Buenos Aires
Country
Argentina
Facility Name
AR003
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
AR304
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
AR308
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
AR311
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
AR313
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
AR314
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
AR312
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
Facility Name
AR009
City
Cordoba
Country
Argentina
Facility Name
AR307
City
Cordoba
Country
Argentina
Facility Name
AR309
City
Cordoba
Country
Argentina
Facility Name
AR305
City
Godoy Cruz
Country
Argentina
Facility Name
AR004
City
Mar del Plata
Country
Argentina
Facility Name
AR005
City
Mendoza
Country
Argentina
Facility Name
AR008
City
Mendoza
Country
Argentina
Facility Name
AR310
City
Mendoza
Country
Argentina
Facility Name
AR010
City
Rosario
Country
Argentina
Facility Name
AR302
City
Santa Fe
Country
Argentina
Facility Name
AR306
City
Santiago del Estero
Country
Argentina
Facility Name
BE003
City
Brugge
Country
Belgium
Facility Name
BE002
City
Brussels
Country
Belgium
Facility Name
BE004
City
Bruxelles
Country
Belgium
Facility Name
BE005
City
Leuven
Country
Belgium
Facility Name
BE001
City
Roeselare
Country
Belgium
Facility Name
BR307
City
Curitiba
Country
Brazil
Facility Name
BR309
City
Curitiba
Country
Brazil
Facility Name
BR303
City
Porto Alegre
Country
Brazil
Facility Name
BR301
City
Rio de Janeiro
Country
Brazil
Facility Name
BR306
City
Rio de Janeiro
Country
Brazil
Facility Name
BR302
City
Sao Paulo
Country
Brazil
Facility Name
BR304
City
São Paulo
Country
Brazil
Facility Name
BR308
City
São Paulo
Country
Brazil
Facility Name
BG005
City
Plovdiv
Country
Bulgaria
Facility Name
BG001
City
Sofia
Country
Bulgaria
Facility Name
BG002
City
Sofia
Country
Bulgaria
Facility Name
BG003
City
Sofia
Country
Bulgaria
Facility Name
BG004
City
Sofia
Country
Bulgaria
Facility Name
BG006
City
Sofia
Country
Bulgaria
Facility Name
CA002
City
Gatineau
Country
Canada
Facility Name
CA309
City
Gatineau
Country
Canada
Facility Name
CA301
City
Halifax
Country
Canada
Facility Name
CA302
City
Kelowna
Country
Canada
Facility Name
CA006
City
London
Country
Canada
Facility Name
CA306
City
Montreal
Country
Canada
Facility Name
CA008
City
Newmarket
Country
Canada
Facility Name
CA304
City
Qubec
Country
Canada
Facility Name
CA001
City
Toronto
Country
Canada
Facility Name
CA305
City
Toronto
Country
Canada
Facility Name
CA308
City
Toronto
Country
Canada
Facility Name
CA307
City
Verdun
Country
Canada
Facility Name
CL004
City
Antofagasta
Country
Chile
Facility Name
CL002
City
Santiago
Country
Chile
Facility Name
CL003
City
Santiago
Country
Chile
Facility Name
CL005
City
Santiago
Country
Chile
Facility Name
CL001
City
Valdivia
Country
Chile
Facility Name
HR304
City
Zabok
Country
Croatia
Facility Name
HR301
City
Zagreb
Country
Croatia
Facility Name
HR302
City
Zagreb
Country
Croatia
Facility Name
CZ006
City
Brno
Country
Czechia
Facility Name
CZ309
City
Chocen
Country
Czechia
Facility Name
CZ306
City
Hradec Kralove
Country
Czechia
Facility Name
CZ007
City
Kutna Hora
Country
Czechia
Facility Name
CZ004
City
Pardubice
Country
Czechia
Facility Name
CZ310
City
Praha 10 - Strasnice
Country
Czechia
Facility Name
CZ003
City
Praha 10
Country
Czechia
Facility Name
CZ304
City
Praha 10
Country
Czechia
Facility Name
CZ001
City
Praha 2
Country
Czechia
Facility Name
CZ002
City
Praha 6
Country
Czechia
Facility Name
CZ301
City
Praha 6
Country
Czechia
Facility Name
CZ303
City
Praha 6
Country
Czechia
Facility Name
CZ005
City
Rychnov nad Kneznou
Country
Czechia
Facility Name
DK003
City
Aarhus N
Country
Denmark
Facility Name
DK001
City
Copenhagen
Country
Denmark
Facility Name
EE301
City
Tallinn
Country
Estonia
Facility Name
EE303
City
Tallin
Country
Estonia
Facility Name
EE302
City
Tartu
Country
Estonia
Facility Name
FI302
City
Kuopio
Country
Finland
Facility Name
FI303
City
Oulu
Country
Finland
Facility Name
FI301
City
Turku
Country
Finland
Facility Name
FR006
City
Besancon Cedex
Country
France
Facility Name
FR301
City
Bordeaux
Country
France
Facility Name
FR308
City
Bron cedex
Country
France
Facility Name
FR309
City
Elancourt
Country
France
Facility Name
FR008
City
Limoges
Country
France
Facility Name
FR302
City
Marseille cedex 5
Country
France
Facility Name
FR003
City
Nantes Cedex
Country
France
Facility Name
FR312
City
Nantes
Country
France
Facility Name
FR303
City
Nice
Country
France
Facility Name
FR005
City
Paris cedex 10
Country
France
Facility Name
FR001
City
Paris
Country
France
Facility Name
FR311
City
Paris
Country
France
Facility Name
FR306
City
Reims
Country
France
Facility Name
FR305
City
Rouen
Country
France
Facility Name
FR004
City
Saint Priest en Jarez
Country
France
Facility Name
FR313
City
Saint Priest en Jarez
Country
France
Facility Name
FR002
City
Toulouse
Country
France
Facility Name
DE002
City
Berlin
Country
Germany
Facility Name
DE006
City
Ellwangen
Country
Germany
Facility Name
DE005
City
Hannover
Country
Germany
Facility Name
DE007
City
Heidelberg
Country
Germany
Facility Name
DE009
City
Munchen
Country
Germany
Facility Name
DE008
City
Ulm
Country
Germany
Facility Name
DE004
City
Unterhaching
Country
Germany
Facility Name
HU304
City
Budapest
Country
Hungary
Facility Name
HU305
City
Budapest
Country
Hungary
Facility Name
HU301
City
Esztergom
Country
Hungary
Facility Name
HU302
City
Szeged
Country
Hungary
Facility Name
IL302
City
Haifa
Country
Israel
Facility Name
IL303
City
Holon
Country
Israel
Facility Name
IL304
City
Ramat Gan
Country
Israel
Facility Name
IT004
City
Ancona
Country
Italy
Facility Name
IT006
City
Brescia
Country
Italy
Facility Name
IT306
City
Brescia
Country
Italy
Facility Name
IT309
City
Brescia
Country
Italy
Facility Name
IT313
City
Cefalù
Country
Italy
Facility Name
IT002
City
Firenze
Country
Italy
Facility Name
IT311
City
Genova
Country
Italy
Facility Name
IT003
City
Lamezia Terme
Country
Italy
Facility Name
IT001
City
Milano
Country
Italy
Facility Name
IT312
City
Monza
Country
Italy
Facility Name
IT005
City
Palermo
Country
Italy
Facility Name
IT007
City
Palermo
Country
Italy
Facility Name
IT307
City
Perugia
Country
Italy
Facility Name
IT301
City
Pisa
Country
Italy
Facility Name
IT305
City
Roma
Country
Italy
Facility Name
IT308
City
Roma
Country
Italy
Facility Name
IT304
City
Torino
Country
Italy
Facility Name
IT310
City
Torrette
Country
Italy
Facility Name
KR303
City
Busan
Country
Korea, Republic of
Facility Name
KR301
City
Incheon
Country
Korea, Republic of
Facility Name
KR308
City
Seongnam-si
Country
Korea, Republic of
Facility Name
KR302
City
Seoul
Country
Korea, Republic of
Facility Name
KR304
City
Seoul
Country
Korea, Republic of
Facility Name
KR305
City
Seoul
Country
Korea, Republic of
Facility Name
KR306
City
Seoul
Country
Korea, Republic of
Facility Name
KR307
City
Seoul
Country
Korea, Republic of
Facility Name
KR309
City
Seoul
Country
Korea, Republic of
Facility Name
LT302
City
Kaunas
Country
Lithuania
Facility Name
LT303
City
Kaunas
Country
Lithuania
Facility Name
LT301
City
Vilnius
Country
Lithuania
Facility Name
LT304
City
Vilnius
Country
Lithuania
Facility Name
PL301
City
Bialystok
Country
Poland
Facility Name
PL304
City
Bydgoszcz
Country
Poland
Facility Name
PL308
City
Gdynia
Country
Poland
Facility Name
PL004
City
Gliwice
Country
Poland
Facility Name
PL007
City
Katowice
Country
Poland
Facility Name
PL309
City
Krakow
Country
Poland
Facility Name
PL302
City
Lodz
Country
Poland
Facility Name
PL310
City
Lubin
Country
Poland
Facility Name
PL306
City
Lublin
Country
Poland
Facility Name
PL307
City
Oswiecim
Country
Poland
Facility Name
PL303
City
Poznan
Country
Poland
Facility Name
PL005
City
Pozna
Country
Poland
Facility Name
PL006
City
Sopot
Country
Poland
Facility Name
PL002
City
Szczecin
Country
Poland
Facility Name
PL311
City
Szczecin
Country
Poland
Facility Name
PL003
City
Warszawa
Country
Poland
Facility Name
PL008
City
Wroclaw
Country
Poland
Facility Name
PT301
City
Amadora
Country
Portugal
Facility Name
PT302
City
Coimbra
Country
Portugal
Facility Name
RO002
City
Bucharest
Country
Romania
Facility Name
RO001
City
Târgu-Mureş
Country
Romania
Facility Name
ZA003
City
Bloemfontein
Country
South Africa
Facility Name
ZA006
City
Cape Town
Country
South Africa
Facility Name
ZA007
City
Cape Town
Country
South Africa
Facility Name
ZA004
City
George
Country
South Africa
Facility Name
ZA001
City
Pretoria
Country
South Africa
Facility Name
ZA002
City
Rosebank
Country
South Africa
Facility Name
ES006
City
Barcelona
Country
Spain
Facility Name
ES005
City
Manresa
Country
Spain
Facility Name
ES004
City
Salamanca
Country
Spain
Facility Name
ES001
City
San Sebastian
Country
Spain
Facility Name
ES002
City
San Vicente del Raspeig
Country
Spain
Facility Name
ES003
City
Santiago de Compostela
Country
Spain
Facility Name
TW301
City
Kaohsiung
Country
Taiwan
Facility Name
TW302
City
Kaohsiung
Country
Taiwan
Facility Name
TW303
City
Tainan
Country
Taiwan
Facility Name
UA008
City
Dnipropetrovsk
Country
Ukraine
Facility Name
UA006
City
Kherson
Country
Ukraine
Facility Name
UA005
City
Kyiv
Country
Ukraine
Facility Name
UA007
City
Kyiv
Country
Ukraine
Facility Name
UA001
City
Lviv
Country
Ukraine
Facility Name
GB307
City
Amersham
Country
United Kingdom
Facility Name
GB301
City
Glasgow
Country
United Kingdom
Facility Name
GB303
City
London
Country
United Kingdom
Facility Name
GB308
City
London
Country
United Kingdom
Facility Name
GB310
City
London
Country
United Kingdom
Facility Name
GB306
City
Plymouth
Country
United Kingdom
Facility Name
GB311
City
Plymouth
Country
United Kingdom
Facility Name
GB309
City
Prescot
Country
United Kingdom
Facility Name
GB305
City
Preston
Country
United Kingdom
Facility Name
GB304
City
Southampton
Country
United Kingdom
Facility Name
GB302
City
Swindon
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

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