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Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor (STARBRIGHT)

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 an AChEI.
  • 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 current AChEI 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

  • US612
  • US625
  • US626
  • US604
  • US627
  • US609
  • US614
  • US608
  • US616
  • US620
  • US603
  • US631
  • US622
  • US611
  • US606
  • US601
  • US607
  • US613
  • US635
  • US630
  • US621
  • US632
  • US633
  • US623
  • US618
  • US619
  • AU603
  • AU609
  • AU602
  • AU604
  • AU606
  • AU601
  • AU610
  • BR608
  • BR609
  • BR607
  • CZ602
  • CZ608
  • CZ605
  • CZ606
  • CZ603
  • CZ601
  • CZ607
  • CZ604
  • DE612
  • DE610
  • DE609
  • DE617
  • DE604
  • DE611
  • DE607
  • DE605
  • DE608
  • DE602
  • DE601
  • DE606
  • DE603
  • DE616
  • IL605
  • IL601
  • IL604
  • IL602
  • IL603
  • KR601
  • KR602
  • KR603
  • KR604
  • MX602
  • MX601
  • MX603
  • MX604
  • MX605
  • MX606
  • RS602
  • RS603
  • RS601
  • SG601
  • SG602
  • SK601
  • SK603
  • SK605
  • SK604
  • SK602
  • ES601
  • ES603
  • ES604
  • ES608
  • ES611
  • ES612
  • ES602
  • ES613
  • ES610
  • ES606
  • ES605
  • ES607
  • CH603
  • CH605
  • CH602
  • CH601
  • TR602
  • TR601
  • TR603
  • TR605
  • TR606
  • TR607
  • GB601
  • GB603

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Idalopirdine 60 mg (or 30 mg)

Arm Description

Placebo adjunct to base treatment with an AChEI

Idalopirdine adjunct to base treatment with an AChEI

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 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 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 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 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 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
December 5, 2013
Last Updated
January 12, 2018
Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02006654
Brief Title
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Acronym
STARBRIGHT
Official Title
Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (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 acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-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 60mg/day as adjunctive therapy to an acetylcholinesterase inhibitor (donepezil 10mg/day, rivastigmine at the patient's individual maintenance dose, or galantamine at the patient's individual maintenance dose), and a 4-week safety follow-up period following study completion or withdrawal from treatment. The dose could be decreased once during the study to 30mg/day if 60mg/day was not well tolerated in the opinion of the investigator. The dose could be increased again to 60mg/day, after which the dose was kept fixed for the remainder of the study. Dose changes were permitted until Week 12 (Visit 5).

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
734 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo adjunct to base treatment with an AChEI
Arm Title
Idalopirdine 60 mg (or 30 mg)
Arm Type
Experimental
Arm Description
Idalopirdine adjunct to base treatment with an AChEI
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 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 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 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 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 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
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 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 an AChEI. 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 current AChEI 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
US612
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
US625
City
Bellflower
State/Province
California
Country
United States
Facility Name
US626
City
Costa Mesa
State/Province
California
Country
United States
Facility Name
US604
City
Oxnard
State/Province
California
Country
United States
Facility Name
US627
City
Santa Ana
State/Province
California
Country
United States
Facility Name
US609
City
Danbury
State/Province
Connecticut
Country
United States
Facility Name
US614
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
US608
City
Deerfield Beach
State/Province
Florida
Country
United States
Facility Name
US616
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
US620
City
Miami
State/Province
Florida
Country
United States
Facility Name
US603
City
North Palm Beach
State/Province
Florida
Country
United States
Facility Name
US631
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
US622
City
Elk Grove Village
State/Province
Illinois
Country
United States
Facility Name
US611
City
Elkhart
State/Province
Indiana
Country
United States
Facility Name
US606
City
Prairie Village
State/Province
Kansas
Country
United States
Facility Name
US601
City
Farmington Hills
State/Province
Michigan
Country
United States
Facility Name
US607
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
US613
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
US635
City
Manchester
State/Province
New Jersey
Country
United States
Facility Name
US630
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
US621
City
Albany
State/Province
New York
Country
United States
Facility Name
US632
City
Staten Island
State/Province
New York
Country
United States
Facility Name
US633
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
US623
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
US618
City
Norristown
State/Province
Pennsylvania
Country
United States
Facility Name
US619
City
Houston
State/Province
Texas
Country
United States
Facility Name
AU603
City
Caulfield
Country
Australia
Facility Name
AU609
City
Glen Iris
Country
Australia
Facility Name
AU602
City
Heidelberg West
Country
Australia
Facility Name
AU604
City
Kanwal
Country
Australia
Facility Name
AU606
City
Newcastle
Country
Australia
Facility Name
AU601
City
West Perth
Country
Australia
Facility Name
AU610
City
Woodville south
Country
Australia
Facility Name
BR608
City
Belo Horizonte
Country
Brazil
Facility Name
BR609
City
Itapira
Country
Brazil
Facility Name
BR607
City
Rio de Janeiro
Country
Brazil
Facility Name
CZ602
City
Chocen
Country
Czechia
Facility Name
CZ608
City
Chocen
Country
Czechia
Facility Name
CZ605
City
Havlickuv Brod
Country
Czechia
Facility Name
CZ606
City
Kladno
Country
Czechia
Facility Name
CZ603
City
Plzen
Country
Czechia
Facility Name
CZ601
City
Prague
Country
Czechia
Facility Name
CZ607
City
Praha 10 - Strasnice
Country
Czechia
Facility Name
CZ604
City
Praha 6
Country
Czechia
Facility Name
DE612
City
Bad Homburg
Country
Germany
Facility Name
DE610
City
Bad Honnef
Country
Germany
Facility Name
DE609
City
Berlin
Country
Germany
Facility Name
DE617
City
Berlin
Country
Germany
Facility Name
DE604
City
Erbach
Country
Germany
Facility Name
DE611
City
Freiburg
Country
Germany
Facility Name
DE607
City
Gelsenkirchen
Country
Germany
Facility Name
DE605
City
Homburg
Country
Germany
Facility Name
DE608
City
Karlstadt
Country
Germany
Facility Name
DE602
City
Mittweida
Country
Germany
Facility Name
DE601
City
Munich
Country
Germany
Facility Name
DE606
City
Rostock
Country
Germany
Facility Name
DE603
City
Ulm
Country
Germany
Facility Name
DE616
City
Unterhaching
Country
Germany
Facility Name
IL605
City
Bat Yam
Country
Israel
Facility Name
IL601
City
Haifa
Country
Israel
Facility Name
IL604
City
Holon
Country
Israel
Facility Name
IL602
City
Ramat Gan
Country
Israel
Facility Name
IL603
City
Tel Aviv
Country
Israel
Facility Name
KR601
City
Seongnam-si
Country
Korea, Republic of
Facility Name
KR602
City
Seoul
Country
Korea, Republic of
Facility Name
KR603
City
Seoul
Country
Korea, Republic of
Facility Name
KR604
City
Seoul
Country
Korea, Republic of
Facility Name
MX602
City
Mexico
Country
Mexico
Facility Name
MX601
City
Monterrey
Country
Mexico
Facility Name
MX603
City
Monterrey
Country
Mexico
Facility Name
MX604
City
Monterrey
Country
Mexico
Facility Name
MX605
City
Monterrey
Country
Mexico
Facility Name
MX606
City
Saltillo
Country
Mexico
Facility Name
RS602
City
Belgrade
Country
Serbia
Facility Name
RS603
City
Kragujevac
Country
Serbia
Facility Name
RS601
City
Novi Sad
Country
Serbia
Facility Name
SG601
City
Singapore
Country
Singapore
Facility Name
SG602
City
Singapore
Country
Singapore
Facility Name
SK601
City
Banska Bystrica
Country
Slovakia
Facility Name
SK603
City
Bratislava
Country
Slovakia
Facility Name
SK605
City
Bratislava
Country
Slovakia
Facility Name
SK604
City
Rimavska Sobota
Country
Slovakia
Facility Name
SK602
City
Svidnik
Country
Slovakia
Facility Name
ES601
City
Barcelona
Country
Spain
Facility Name
ES603
City
Barcelona
Country
Spain
Facility Name
ES604
City
Barcelona
Country
Spain
Facility Name
ES608
City
Barcelona
Country
Spain
Facility Name
ES611
City
Bilbao
Country
Spain
Facility Name
ES612
City
Burgos
Country
Spain
Facility Name
ES602
City
Lleida
Country
Spain
Facility Name
ES613
City
Madrid
Country
Spain
Facility Name
ES610
City
Sant Cugat del Vallès
Country
Spain
Facility Name
ES606
City
Sevilla
Country
Spain
Facility Name
ES605
City
Terrassa
Country
Spain
Facility Name
ES607
City
Valencia
Country
Spain
Facility Name
CH603
City
Biel
Country
Switzerland
Facility Name
CH605
City
Lausanne
Country
Switzerland
Facility Name
CH602
City
Les Acacias
Country
Switzerland
Facility Name
CH601
City
Schlieren
Country
Switzerland
Facility Name
TR602
City
Balova
Country
Turkey
Facility Name
TR601
City
Istanbul
Country
Turkey
Facility Name
TR603
City
İstanbul
Country
Turkey
Facility Name
TR605
City
Istanbul
Country
Turkey
Facility Name
TR606
City
Izmir
Country
Turkey
Facility Name
TR607
City
Samsun
Country
Turkey
Facility Name
GB601
City
Brentford
Country
United Kingdom
Facility Name
GB603
City
Northampton
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

Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

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