Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
STARBRIGHT
Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
2 other identifiers
interventional
734
15 countries
107
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2014
Typical duration for phase_3
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
February 7, 2018
CompletedFebruary 7, 2018
January 1, 2018
2.8 years
December 5, 2013
January 12, 2018
January 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Baseline and Week 24
Secondary Outcomes (10)
Change in Global Impression
Baseline and Week 24
Change in Daily Functioning
Baseline and Week 24
Change in Behavioural Disturbance
Baseline and Week 24
Change in Individual Behavioural Disturbance Items
Baseline and Week 24
Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline
Baseline and Week 24
- +5 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo adjunct to base treatment with an AChEI
Idalopirdine 60 mg (or 30 mg)
EXPERIMENTALIdalopirdine adjunct to base treatment with an AChEI
Interventions
Once daily, encapsulated tablets, orally
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
- Otsuka Pharmaceutical Co., Ltd.collaborator
Study Sites (107)
US612
Mesa, Arizona, United States
US625
Bellflower, California, United States
US626
Costa Mesa, California, United States
US604
Oxnard, California, United States
US627
Santa Ana, California, United States
US609
Danbury, Connecticut, United States
US614
Norwalk, Connecticut, United States
US608
Deerfield Beach, Florida, United States
US616
Hialeah, Florida, United States
US620
Miami, Florida, United States
US603
North Palm Beach, Florida, United States
US631
Port Charlotte, Florida, United States
US622
Elk Grove Village, Illinois, United States
US611
Elkhart, Indiana, United States
US606
Prairie Village, Kansas, United States
US601
Farmington Hills, Michigan, United States
US607
St Louis, Missouri, United States
US613
Lawrenceville, New Jersey, United States
US635
Paterson, New Jersey, United States
US630
Toms River, New Jersey, United States
US621
Albany, New York, United States
US632
Staten Island, New York, United States
US633
Charlotte, North Carolina, United States
US623
Oklahoma City, Oklahoma, United States
US618
Norristown, Pennsylvania, United States
US619
Houston, Texas, United States
AU603
Caulfield, Australia
AU609
Glen Iris, Australia
AU602
Heidelberg West, Australia
AU604
Kanwal, Australia
AU606
Newcastle, Australia
AU601
West Perth, Australia
AU610
Woodville South, Australia
BR608
Belo Horizonte, Brazil
BR609
Itapira, Brazil
BR607
Rio de Janeiro, Brazil
CZ602
Choceň, Czechia
CZ608
Choceň, Czechia
CZ605
Havlíčkův Brod, Czechia
CZ606
Kladno, Czechia
CZ603
Pilsen, Czechia
CZ601
Prague, Czechia
CZ604
Prague, Czechia
CZ607
Praha 10 - Strasnice, Czechia
DE612
Bad Homburg, Germany
DE610
Bad Honnef, Germany
DE609
Berlin, Germany
DE617
Berlin, Germany
DE604
Erbach im Odenwald, Germany
DE611
Freiburg im Breisgau, Germany
DE607
Gelsenkirchen, Germany
DE605
Homburg, Germany
DE608
Karlstadt am Main, Germany
DE602
Mittweida, Germany
DE601
Munich, Germany
DE606
Rostock, Germany
DE603
Ulm, Germany
DE616
Unterhaching, Germany
IL605
Bat Yam, Israel
IL601
Haifa, Israel
IL604
Holon, Israel
IL602
Ramat Gan, Israel
IL603
Tel Aviv, Israel
MX602
México, Mexico
MX601
Monterrey, Mexico
MX603
Monterrey, Mexico
MX604
Monterrey, Mexico
MX605
Monterrey, Mexico
MX606
Saltillo, Mexico
RS602
Belgrade, Serbia
RS603
Kragujevac, Serbia
RS601
Novi Sad, Serbia
SG601
Singapore, Singapore
SG602
Singapore, Singapore
SK601
Banská Bystrica, Slovakia
SK603
Bratislava, Slovakia
SK605
Bratislava, Slovakia
SK604
Rimavská Sobota, Slovakia
SK602
Svidník, Slovakia
KR601
Seongnam-si, South Korea
KR602
Seoul, South Korea
KR603
Seoul, South Korea
KR604
Seoul, South Korea
ES601
Barcelona, Spain
ES603
Barcelona, Spain
ES604
Barcelona, Spain
ES608
Barcelona, Spain
ES611
Bilbao, Spain
ES612
Burgos, Spain
ES602
Lleida, Spain
ES613
Madrid, Spain
ES610
Sant Cugat del Vallès, Spain
ES606
Seville, Spain
ES605
Terrassa, Spain
ES607
Valencia, Spain
CH603
Biel, Switzerland
CH605
Lausanne, Switzerland
CH602
Les Acacias, Switzerland
CH601
Schlieren, Switzerland
TR602
Balova, Turkey (Türkiye)
TR601
Istanbul, Turkey (Türkiye)
TR603
Istanbul, Turkey (Türkiye)
TR605
Istanbul, Turkey (Türkiye)
TR606
Izmir, Turkey (Türkiye)
TR607
Samsun, Turkey (Türkiye)
GB601
Brentford, United Kingdom
GB603
Northampton, United Kingdom
Related Publications (3)
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.
PMID: 31193334DERIVEDCummings 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.
PMID: 30474567DERIVEDAtri 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.
PMID: 29318278DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Email contact via
- Organization
- H. Lundbeck A/S
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2013
First Posted
December 10, 2013
Study Start
March 1, 2014
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
February 7, 2018
Results First Posted
February 7, 2018
Record last verified: 2018-01