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Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil (STARBEAM)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Idalopirdine
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 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.

Sites / Locations

  • US338
  • US342
  • US322
  • US305
  • US346
  • US327
  • US315
  • US351
  • US307
  • US301
  • US337
  • US332
  • US308
  • US320
  • US347
  • US340
  • US303
  • US313
  • US335
  • US345
  • US309
  • US302
  • US304
  • US360
  • US318
  • US334
  • US350
  • US344
  • US310
  • US321
  • US330
  • US339
  • US312
  • US316
  • US336
  • US323
  • US349
  • US306
  • US352
  • US333
  • US314
  • US324
  • US341
  • US325
  • US319
  • US356
  • US343
  • US354
  • AR303
  • AR301
  • AR304
  • AR308
  • AR311
  • AR313
  • AR314
  • AR315
  • AR312
  • AR309
  • AR307
  • AR305
  • AR310
  • AR302
  • AR306
  • BR307
  • BR309
  • BR301
  • BR306
  • BR308
  • CA301
  • CA302
  • CA306
  • CA304
  • CA303
  • CA305
  • HR304
  • HR301
  • HR302
  • HR303
  • CZ305
  • CZ306
  • CZ309
  • CZ308
  • CZ310
  • CZ304
  • CZ307
  • CZ301
  • CZ303
  • CZ302
  • EE301
  • EE303
  • EE302
  • FI302
  • FI303
  • FI301
  • FR301
  • FR308
  • FR307
  • FR304
  • FR309
  • FR302
  • FR303
  • FR306
  • FR305
  • HU304
  • HU305
  • HU301
  • HU303
  • HU302
  • IE301
  • IL302
  • IL303
  • IL304
  • IT306
  • IT309
  • IT311
  • IT312
  • IT302
  • IT313
  • IT307
  • IT301
  • IT305
  • IT308
  • IT304
  • IT310
  • KR303
  • KR301
  • KR308
  • KR302
  • KR304
  • KR305
  • KR306
  • KR307
  • KR309
  • LT302
  • LT303
  • LT301
  • LT304
  • PL301
  • PL304
  • PL308
  • PL309
  • PL302
  • PL310
  • PL306
  • PL307
  • PL303
  • PT301
  • PT302
  • TW301
  • TW302
  • TW303
  • TW304
  • TW305
  • GB307
  • GB301
  • GB303
  • GB308
  • GB306
  • GB305
  • GB304
  • GB302
  • GB309

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Idalopirdine 10 mg

Idalopirdine 30 mg

Arm Description

Placebo adjunct to 10 mg Donepezil

Idalopirdine adjunct to 10 mg Donepezil

Idalopirdine adjunct to 10 mg Donepezil

Outcomes

Primary Outcome Measures

Change in Cognition
Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score. The Alzheimer's Disease Assessment Scale - Cognitive subscale (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).

Secondary Outcome Measures

Change in Daily Functioning
Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The Alzheimer's Disease Cooperative Study - Activities of Daily Living (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 Global Impression
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24. The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change 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 Behavioural Disturbance
Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score. The Neuropsychiatric Inventory 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 Individual Behavioural Disturbance Items
Change in single NPI item scores at Week 24. The Neuropsychiatric Inventory 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 then 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]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome.
Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline
Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline The Neuropsychiatric Inventory 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 then 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 score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome.
Number of Participants With Clinical Improvement
Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])
Number of Participants With Clinical Worsening
Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])
Change in Cognitive Aspects of Mental Function
Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (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 Health-related Quality of Life (EQ-5D) Utility Score
Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome.
Change in Health-related Quality of Life (EQ-5D VAS)
Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS). The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Full Information

First Posted
December 5, 2013
Last Updated
January 23, 2018
Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02006641
Brief Title
Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
Acronym
STARBEAM
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
858 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo adjunct to 10 mg Donepezil
Arm Title
Idalopirdine 10 mg
Arm Type
Experimental
Arm Description
Idalopirdine adjunct to 10 mg Donepezil
Arm Title
Idalopirdine 30 mg
Arm Type
Experimental
Arm Description
Idalopirdine adjunct to 10 mg Donepezil
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily, matching placebo capsules, orally
Intervention Type
Drug
Intervention Name(s)
Idalopirdine
Other Intervention Name(s)
Lu AE58054
Intervention Description
Once daily, encapsulated tablets, orally
Primary Outcome Measure Information:
Title
Change in Cognition
Description
Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score. The Alzheimer's Disease Assessment Scale - Cognitive subscale (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 and Week 24
Secondary Outcome Measure Information:
Title
Change in Daily Functioning
Description
Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The Alzheimer's Disease Cooperative Study - Activities of Daily Living (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 and Week 24
Title
Change in Global Impression
Description
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24. The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change 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
Baseline and Week 24
Title
Change in Behavioural Disturbance
Description
Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score. The Neuropsychiatric Inventory 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 and Week 24
Title
Change in Individual Behavioural Disturbance Items
Description
Change in single NPI item scores at Week 24. The Neuropsychiatric Inventory 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 then 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]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome.
Time Frame
Baseline and Week 24
Title
Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline
Description
Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline The Neuropsychiatric Inventory 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 then 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 score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome.
Time Frame
Baseline and Week 24
Title
Number of Participants With Clinical Improvement
Description
Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])
Time Frame
Week 24
Title
Number of Participants With Clinical Worsening
Description
Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])
Time Frame
Week 24
Title
Change in Cognitive Aspects of Mental Function
Description
Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (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 and Week 24
Title
Change in Health-related Quality of Life (EQ-5D) Utility Score
Description
Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome.
Time Frame
Baseline and Week 24
Title
Change in Health-related Quality of Life (EQ-5D VAS)
Description
Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS). The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
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
US338
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
US342
City
Fayetteville
State/Province
Arkansas
Country
United States
Facility Name
US322
City
Anaheim
State/Province
California
Country
United States
Facility Name
US305
City
Carson
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
US315
City
Lomita
State/Province
California
Country
United States
Facility Name
US351
City
Oceanside
State/Province
California
Country
United States
Facility Name
US307
City
Redlands
State/Province
California
Country
United States
Facility Name
US301
City
Santa Rosa
State/Province
California
Country
United States
Facility Name
US337
City
New London
State/Province
Connecticut
Country
United States
Facility Name
US332
City
Stamford
State/Province
Connecticut
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
US335
City
Naples
State/Province
Florida
Country
United States
Facility Name
US345
City
Orange City
State/Province
Florida
Country
United States
Facility Name
US309
City
Palm Beach Gardens
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
US318
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
US334
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
US350
City
Belmont
State/Province
Massachusetts
Country
United States
Facility Name
US344
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
US310
City
Saint Paul
State/Province
Minnesota
Country
United States
Facility Name
US321
City
Hattiesburg
State/Province
Mississippi
Country
United States
Facility Name
US330
City
Creve Coeur
State/Province
Missouri
Country
United States
Facility Name
US339
City
Manchester
State/Province
New Jersey
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
US323
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
US349
City
Cleveland
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
US314
City
Allentown
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
US325
City
Reading
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
AR303
City
Banfield
Country
Argentina
Facility Name
AR301
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
AR315
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
AR312
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
Facility Name
AR309
City
Cordoba
Country
Argentina
Facility Name
AR307
City
Córdoba
Country
Argentina
Facility Name
AR305
City
Godoy Cruz
Country
Argentina
Facility Name
AR310
City
Mendoza
Country
Argentina
Facility Name
AR302
City
Santa Fe
Country
Argentina
Facility Name
AR306
City
Santiago del Estero
Country
Argentina
Facility Name
BR307
City
Curitiba
Country
Brazil
Facility Name
BR309
City
Curitiba
Country
Brazil
Facility Name
BR301
City
Rio de Janeiro
Country
Brazil
Facility Name
BR306
City
Rio de Janeiro
Country
Brazil
Facility Name
BR308
City
San Paolo
Country
Brazil
Facility Name
CA301
City
Halifax
Country
Canada
Facility Name
CA302
City
Kelowna
Country
Canada
Facility Name
CA306
City
Montreal
Country
Canada
Facility Name
CA304
City
Qubec
Country
Canada
Facility Name
CA303
City
Sherbrooke
Country
Canada
Facility Name
CA305
City
Toronto
Country
Canada
Facility Name
HR304
City
Zabok
Country
Croatia
Facility Name
HR301
City
Zagreb
Country
Croatia
Facility Name
HR302
City
Zagreb
Country
Croatia
Facility Name
HR303
City
Zagreb
Country
Croatia
Facility Name
CZ305
City
Brno
Country
Czechia
Facility Name
CZ306
City
Chocen
Country
Czechia
Facility Name
CZ309
City
Chocen
Country
Czechia
Facility Name
CZ308
City
Pardubice
Country
Czechia
Facility Name
CZ310
City
Praha 10 - Strasnice
Country
Czechia
Facility Name
CZ304
City
Praha 10
Country
Czechia
Facility Name
CZ307
City
Praha 2
Country
Czechia
Facility Name
CZ301
City
Praha 6
Country
Czechia
Facility Name
CZ303
City
Praha 6
Country
Czechia
Facility Name
CZ302
City
Rychnov nad Kneznou
Country
Czechia
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
FR301
City
Bordeaux
Country
France
Facility Name
FR308
City
Bron
Country
France
Facility Name
FR307
City
Colmar cedex
Country
France
Facility Name
FR304
City
Dijon
Country
France
Facility Name
FR309
City
Elancourt
Country
France
Facility Name
FR302
City
Marseille cedex 5
Country
France
Facility Name
FR303
City
Nice Cedex 1
Country
France
Facility Name
FR306
City
Reims
Country
France
Facility Name
FR305
City
Rouen
Country
France
Facility Name
HU304
City
Budapest
Country
Hungary
Facility Name
HU305
City
Budapest
Country
Hungary
Facility Name
HU301
City
Esztergom
Country
Hungary
Facility Name
HU303
City
Gyor
Country
Hungary
Facility Name
HU302
City
Szeged
Country
Hungary
Facility Name
IE301
City
Cork
Country
Ireland
Facility Name
IL302
City
Haifa
Country
Israel
Facility Name
IL303
City
Holon
Country
Israel
Facility Name
IL304
City
Ramat Gan
Country
Israel
Facility Name
IT306
City
Brescia
Country
Italy
Facility Name
IT309
City
Brescia
Country
Italy
Facility Name
IT311
City
Genova
Country
Italy
Facility Name
IT312
City
Monza
Country
Italy
Facility Name
IT302
City
Naples
Country
Italy
Facility Name
IT313
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
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
PT301
City
Amadora
Country
Portugal
Facility Name
PT302
City
Coimbra
Country
Portugal
Facility Name
TW301
City
Kaohsiung
Country
Taiwan
Facility Name
TW302
City
Kaohsiung
Country
Taiwan
Facility Name
TW303
City
Taichung
Country
Taiwan
Facility Name
TW304
City
Taipei
Country
Taiwan
Facility Name
TW305
City
Taipei
Country
Taiwan
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
GB306
City
Plymouth
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
Facility Name
GB309
City
Warrington
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31193334
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.
Results Reference
derived
PubMed Identifier
30474567
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.
Results Reference
derived
PubMed Identifier
29318278
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.
Results Reference
derived

Learn more about this trial

Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil

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