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Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil (STARSHINE)

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

  • US027
  • US012
  • US024
  • US053
  • US023
  • US015
  • US045
  • US002
  • US058
  • US018
  • US060
  • US042
  • US021
  • US050
  • US019
  • US038
  • US001
  • US020
  • US048
  • US030
  • US051
  • US040
  • US036
  • US032
  • US035
  • US041
  • US054
  • US046
  • US028
  • US044
  • US049
  • US010
  • US014
  • US008
  • US029
  • US056
  • US037
  • US043
  • US007
  • US006
  • US052
  • US026
  • US057
  • US047
  • US025
  • US004
  • AR002
  • AR003
  • AR006
  • AR007
  • AR009
  • AR004
  • AR005
  • AR008
  • AR010
  • BE003
  • BE002
  • BE004
  • BE005
  • BE001
  • BE006
  • BG005
  • BG001
  • BG002
  • BG003
  • BG004
  • BG006
  • BG007
  • CA002
  • CA006
  • CA008
  • CA001
  • CA004
  • CL004
  • CL002
  • CL003
  • CL005
  • CL001
  • CZ006
  • CZ007
  • CZ004
  • CZ003
  • CZ001
  • CZ002
  • CZ005
  • DK003
  • DK001
  • DK002
  • FR006
  • FR008
  • FR003
  • FR005
  • FR001
  • FR004
  • FR002
  • DE002
  • DE006
  • DE010
  • DE005
  • DE007
  • DE009
  • DE008
  • DE004
  • IT004
  • IT006
  • IT002
  • IT005
  • IT003
  • IT001
  • IT007
  • PL004
  • PL007
  • PL005
  • PL006
  • PL002
  • PL003
  • PL008
  • RO002
  • RO001
  • ZA003
  • ZA006
  • ZA007
  • ZA004
  • ZA005
  • ZA001
  • ZA002
  • ES002
  • ES006
  • ES005
  • ES004
  • ES001
  • ES003
  • UA008
  • UA006
  • UA005
  • UA007
  • UA001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Idalopirdine 30 mg

Idalopirdine 60 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.
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])
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
September 27, 2013
Last Updated
August 22, 2017
Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01955161
Brief Title
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Acronym
STARSHINE
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
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 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 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.

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
933 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo adjunct to 10 mg Donepezil
Arm Title
Idalopirdine 30 mg
Arm Type
Experimental
Arm Description
Idalopirdine adjunct to 10 mg Donepezil
Arm Title
Idalopirdine 60 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
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 to 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 to 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 to 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 to 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 to 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 to Week 24
Title
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
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 to 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 to 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 to 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
US027
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
US012
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
US024
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
US053
City
Glendale
State/Province
California
Country
United States
Facility Name
US023
City
Imperial
State/Province
California
Country
United States
Facility Name
US015
City
La Jolla
State/Province
California
Country
United States
Facility Name
US045
City
Long Beach
State/Province
California
Country
United States
Facility Name
US002
City
Los Angeles
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
US060
City
Denver
State/Province
Colorado
Country
United States
Facility Name
US042
City
Boca Raton
State/Province
Florida
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
US019
City
Orlando
State/Province
Florida
Country
United States
Facility Name
US038
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
US001
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
US020
City
Atlanta
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
US051
City
Joliet
State/Province
Illinois
Country
United States
Facility Name
US040
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
US036
City
Freeport
State/Province
Maine
Country
United States
Facility Name
US032
City
Newton
State/Province
Massachusetts
Country
United States
Facility Name
US035
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
US041
City
Flowood
State/Province
Mississippi
Country
United States
Facility Name
US054
City
Saint Louis
State/Province
Missouri
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
US049
City
Albany
State/Province
New York
Country
United States
Facility Name
US010
City
Amherst
State/Province
New York
Country
United States
Facility Name
US014
City
Manhasset
State/Province
New York
Country
United States
Facility Name
US008
City
New York
State/Province
New York
Country
United States
Facility Name
US029
City
New York
State/Province
New York
Country
United States
Facility Name
US056
City
New York
State/Province
New York
Country
United States
Facility Name
US037
City
Orangeburg
State/Province
New York
Country
United States
Facility Name
US043
City
Staten Island
State/Province
New York
Country
United States
Facility Name
US007
City
Centerville
State/Province
Ohio
Country
United States
Facility Name
US006
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
US052
City
Edmond
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
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
AR002
City
Buenos Aires
Country
Argentina
Facility Name
AR003
City
Buenos Aires
Country
Argentina
Facility Name
AR006
City
Buenos Aires
Country
Argentina
Facility Name
AR007
City
Buenos Aires
Country
Argentina
Facility Name
AR009
City
Cordoba
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
AR010
City
Rosario
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
BE006
City
Thuin
Country
Belgium
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
BG007
City
Varna
Country
Bulgaria
Facility Name
CA002
City
Gatineau
Country
Canada
Facility Name
CA006
City
London
Country
Canada
Facility Name
CA008
City
Newmarket
Country
Canada
Facility Name
CA001
City
Toronto
Country
Canada
Facility Name
CA004
City
Toronto
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
CZ006
City
Brno
Country
Czechia
Facility Name
CZ007
City
Kutna Hora
Country
Czechia
Facility Name
CZ004
City
Pardubice
Country
Czechia
Facility Name
CZ003
City
Praha 10
Country
Czechia
Facility Name
CZ001
City
Praha 2
Country
Czechia
Facility Name
CZ002
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
DK002
City
Odense C
Country
Denmark
Facility Name
FR006
City
Besancon Cedex
Country
France
Facility Name
FR008
City
Limoges Cedex1
Country
France
Facility Name
FR003
City
Nantes Cedex
Country
France
Facility Name
FR005
City
Paris cedex 10
Country
France
Facility Name
FR001
City
Paris
Country
France
Facility Name
FR004
City
Saint Etienne Cedex 2
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
DE010
City
Günzburg
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
IT004
City
Ancona
Country
Italy
Facility Name
IT006
City
Brescia
Country
Italy
Facility Name
IT002
City
Firenze
Country
Italy
Facility Name
IT005
City
Genoa
Country
Italy
Facility Name
IT003
City
Lamezia Terme
Country
Italy
Facility Name
IT001
City
Milano
Country
Italy
Facility Name
IT007
City
Palermo
Country
Italy
Facility Name
PL004
City
Gliwice
Country
Poland
Facility Name
PL007
City
Katowice
Country
Poland
Facility Name
PL005
City
Poznan
Country
Poland
Facility Name
PL006
City
Sopot
Country
Poland
Facility Name
PL002
City
Szczecin
Country
Poland
Facility Name
PL003
City
Warszawa
Country
Poland
Facility Name
PL008
City
Wroclaw
Country
Poland
Facility Name
RO002
City
Bucharest
Country
Romania
Facility Name
RO001
City
Tirgu Mures
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
ZA005
City
Port Elizabeth
Country
South Africa
Facility Name
ZA001
City
Pretoria
Country
South Africa
Facility Name
ZA002
City
Rosebank
Country
South Africa
Facility Name
ES002
City
Alicante
Country
Spain
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
ES003
City
Santiago de Compostela
Country
Spain
Facility Name
UA008
City
Dnipropetrovsk
Country
Ukraine
Facility Name
UA006
City
Kherson,Vil. Stepanivka
Country
Ukraine
Facility Name
UA005
City
Kyiv
Country
Ukraine
Facility Name
UA007
City
Kyiv
Country
Ukraine
Facility Name
UA001
City
Lviv
Country
Ukraine

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

Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

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