Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
STARBEAM
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
2 other identifiers
interventional
858
19 countries
162
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2014
Typical duration for phase_3
162 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
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
February 20, 2018
CompletedFebruary 20, 2018
January 1, 2018
2.8 years
December 5, 2013
December 19, 2017
January 23, 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 Daily Functioning
Baseline and Week 24
Change in Global Impression
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 (3)
Placebo
PLACEBO COMPARATORPlacebo adjunct to 10 mg Donepezil
Idalopirdine 10 mg
EXPERIMENTALIdalopirdine adjunct to 10 mg Donepezil
Idalopirdine 30 mg
EXPERIMENTALIdalopirdine adjunct to 10 mg Donepezil
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 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.
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
- Otsuka Pharmaceutical Co., Ltd.collaborator
Study Sites (162)
US338
Phoenix, Arizona, United States
US342
Fayetteville, Arkansas, United States
US322
Anaheim, California, United States
US305
Carson, California, United States
US346
Costa Mesa, California, United States
US327
Fullerton, California, United States
US315
Lomita, California, United States
US351
Oceanside, California, United States
US307
Redlands, California, United States
US301
Santa Rosa, California, United States
US337
New London, Connecticut, United States
US332
Stamford, Connecticut, United States
US308
Delray Beach, Florida, United States
US320
Hallandale, Florida, United States
US347
Hialeah, Florida, United States
US340
Lake Worth, Florida, United States
US303
Miami, Florida, United States
US313
Miami, Florida, United States
US335
Naples, Florida, United States
US345
Orange City, Florida, United States
US309
Palm Beach Gardens, Florida, United States
US302
Sunrise, Florida, United States
US304
Atlanta, Georgia, United States
US360
Augusta, Georgia, United States
US318
Decatur, Georgia, United States
US334
Lake Charles, Louisiana, United States
US350
Belmont, Massachusetts, United States
US344
Boston, Massachusetts, United States
US310
Saint Paul, Minnesota, United States
US321
Hattiesburg, Mississippi, United States
US330
Creve Coeur, Missouri, United States
US339
Paterson, New Jersey, United States
US312
Staten Island, New York, United States
US316
Charlotte, North Carolina, United States
US336
Winston-Salem, North Carolina, United States
US323
Cincinnati, Ohio, United States
US349
Cleveland, Ohio, United States
US306
Columbus, Ohio, United States
US352
Lakewood, Ohio, United States
US333
Oklahoma City, Oklahoma, United States
US314
Allentown, Pennsylvania, United States
US324
Pittsburgh, Pennsylvania, United States
US341
Pittsburgh, Pennsylvania, United States
US325
Reading, Pennsylvania, United States
US319
Port Royal, South Carolina, United States
US356
Cordova, Tennessee, United States
US343
Fort Worth, Texas, United States
US354
Houston, Texas, United States
AR303
Banfield, Argentina
AR312
Buenos Aires, Argentina
AR301
Ciudad Autonoma Buenos Aires, Argentina
AR304
Ciudad Autonoma Buenos Aires, Argentina
AR308
Ciudad Autonoma Buenos Aires, Argentina
AR311
Ciudad Autonoma Buenos Aires, Argentina
AR313
Ciudad Autonoma Buenos Aires, Argentina
AR314
Ciudad Autonoma Buenos Aires, Argentina
AR315
Ciudad Autonoma Buenos Aires, Argentina
AR307
Córdoba, Argentina
AR309
Córdoba, Argentina
AR305
Godoy Cruz, Argentina
AR310
Mendoza, Argentina
AR302
Santa Fe, Argentina
AR306
Santiago del Estero, Argentina
BR307
Curitiba, Brazil
BR309
Curitiba, Brazil
BR301
Rio de Janeiro, Brazil
BR306
Rio de Janeiro, Brazil
BR308
São Paulo, Brazil
CA301
Halifax, Canada
CA302
Kelowna, Canada
CA306
Montreal, Canada
CA304
Qubec, Canada
CA303
Sherbrooke, Canada
CA305
Toronto, Canada
HR304
Zabok, Croatia
HR301
Zagreb, Croatia
HR302
Zagreb, Croatia
HR303
Zagreb, Croatia
CZ305
Brno, Czechia
CZ306
Choceň, Czechia
CZ309
Choceň, Czechia
CZ308
Pardubice, Czechia
CZ301
Prague, Czechia
CZ303
Prague, Czechia
CZ304
Prague, Czechia
CZ307
Prague, Czechia
CZ310
Praha 10 - Strasnice, Czechia
CZ302
Rychnov nad Kněžnou, Czechia
EE301
Tallinn, Estonia
EE303
Tallinn, Estonia
EE302
Tartu, Estonia
FI302
Kuopio, Finland
FI303
Oulu, Finland
FI301
Turku, Finland
FR301
Bordeaux, France
FR308
Bron, France
FR307
Colmar, France
FR304
Dijon, France
FR309
Élancourt, France
FR302
Marseille, France
FR303
Nice, France
FR306
Reims, France
FR305
Rouen, France
HU304
Budapest, Hungary
HU305
Budapest, Hungary
HU301
Esztergom, Hungary
HU303
Győr, Hungary
HU302
Szeged, Hungary
IE301
Cork, Ireland
IL302
Haifa, Israel
IL303
Holon, Israel
IL304
Ramat Gan, Israel
IT306
Brescia, Italy
IT309
Brescia, Italy
IT311
Genova, Italy
IT312
Monza, Italy
IT302
Naples, Italy
IT313
Palermo, Italy
IT307
Perugia, Italy
IT301
Pisa, Italy
IT305
Roma, Italy
IT308
Roma, Italy
IT304
Torino, Italy
IT310
Torrette, Italy
LT302
Kaunas, Lithuania
LT303
Kaunas, Lithuania
LT301
Vilnius, Lithuania
LT304
Vilnius, Lithuania
PL301
Bialystok, Poland
PL304
Bydgoszcz, Poland
PL308
Gdynia, Poland
PL309
Krakow, Poland
PL302
Lodz, Poland
PL310
Lubin, Poland
PL306
Lublin, Poland
PL307
Oświęcim, Poland
PL303
Poznan, Poland
PT301
Amadora, Portugal
PT302
Coimbra, Portugal
KR303
Busan, South Korea
KR301
Incheon, South Korea
KR308
Seongnam-si, South Korea
KR302
Seoul, South Korea
KR304
Seoul, South Korea
KR305
Seoul, South Korea
KR306
Seoul, South Korea
KR307
Seoul, South Korea
KR309
Seoul, South Korea
TW301
Kaohsiung City, Taiwan
TW302
Kaohsiung City, Taiwan
TW303
Taichung, Taiwan
TW304
Taipei, Taiwan
TW305
Taipei, Taiwan
GB307
Amersham, United Kingdom
GB301
Glasgow, United Kingdom
GB303
London, United Kingdom
GB308
London, United Kingdom
GB306
Plymouth, United Kingdom
GB305
Preston, United Kingdom
GB304
Southampton, United Kingdom
GB302
Swindon, United Kingdom
GB309
Warrington, 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
February 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 20, 2018
Results First Posted
February 20, 2018
Record last verified: 2018-01