Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
STARSHINE
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
933
16 countries
137
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 Oct 2013
Typical duration for phase_3
137 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
September 27, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
September 19, 2017
CompletedSeptember 19, 2017
August 1, 2017
2.8 years
September 27, 2013
July 11, 2017
August 22, 2017
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 to Week 24
Secondary Outcomes (10)
Change in Daily Functioning
Baseline to Week 24
Change in Global Impression
Baseline to Week 24
Change in Behavioural Disturbance
Baseline to Week 24
Change in Individual Behavioural Disturbance Items
Baseline to Week 24
Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline
Baseline to Week 24
- +5 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo adjunct to 10 mg Donepezil
Idalopirdine 30 mg
EXPERIMENTALIdalopirdine adjunct to 10 mg Donepezil
Idalopirdine 60 mg
EXPERIMENTALIdalopirdine adjunct to 10 mg Donepezil
Interventions
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 (137)
US027
Birmingham, Alabama, United States
US012
Phoenix, Arizona, United States
US024
Little Rock, Arkansas, United States
US053
Glendale, California, United States
US023
Imperial, California, United States
US015
La Jolla, California, United States
US045
Long Beach, California, United States
US002
Los Angeles, California, United States
US058
San Francisco, California, United States
US018
Santa Ana, California, United States
US060
Denver, Colorado, United States
US042
Boca Raton, Florida, United States
US021
Bradenton, Florida, United States
US050
Brooksville, Florida, United States
US019
Orlando, Florida, United States
US038
Port Charlotte, Florida, United States
US001
West Palm Beach, Florida, United States
US020
Atlanta, Georgia, United States
US048
Kailua, Hawaii, United States
US030
Chicago, Illinois, United States
US051
Joliet, Illinois, United States
US040
Indianapolis, Indiana, United States
US036
Freeport, Maine, United States
US032
Newton, Massachusetts, United States
US035
Kalamazoo, Michigan, United States
US041
Flowood, Mississippi, United States
US054
St Louis, Missouri, United States
US046
Princeton, New Jersey, United States
US028
Toms River, New Jersey, United States
US044
Toms River, New Jersey, United States
US049
Albany, New York, United States
US010
Amherst, New York, United States
US014
Manhasset, New York, United States
US008
New York, New York, United States
US029
New York, New York, United States
US056
New York, New York, United States
US037
Orangeburg, New York, United States
US043
Staten Island, New York, United States
US007
Centerville, Ohio, United States
US006
Columbus, Ohio, United States
US052
Edmond, Oklahoma, United States
US026
Portland, Oregon, United States
US057
Jenkintown, Pennsylvania, United States
US047
Arlington, Virginia, United States
US025
Madison, Wisconsin, United States
US004
Milwaukee, Wisconsin, United States
AR002
Buenos Aires, Argentina
AR003
Buenos Aires, Argentina
AR006
Buenos Aires, Argentina
AR007
Buenos Aires, Argentina
AR009
Córdoba, Argentina
AR004
Mar del Plata, Argentina
AR005
Mendoza, Argentina
AR008
Mendoza, Argentina
AR010
Rosario, Argentina
BE003
Bruges, Belgium
BE002
Brussels, Belgium
BE004
Brussels, Belgium
BE005
Leuven, Belgium
BE001
Roeselare, Belgium
BE006
Thuin, Belgium
BG005
Plovdiv, Bulgaria
BG001
Sofia, Bulgaria
BG002
Sofia, Bulgaria
BG003
Sofia, Bulgaria
BG004
Sofia, Bulgaria
BG006
Sofia, Bulgaria
BG007
Varna, Bulgaria
CA002
Gatineau, Canada
CA006
London, Canada
CA008
Newmarket, Canada
CA001
Toronto, Canada
CA004
Toronto, Canada
CL004
Antofagasta, Chile
CL002
Santiago, Chile
CL003
Santiago, Chile
CL005
Santiago, Chile
CL001
Valdivia, Chile
CZ006
Brno, Czechia
CZ007
Kutná Hora, Czechia
CZ004
Pardubice, Czechia
CZ001
Prague, Czechia
CZ002
Prague, Czechia
CZ003
Prague, Czechia
CZ005
Rychnov nad Kněžnou, Czechia
DK003
Aarhus N, Denmark
DK001
Copenhagen, Denmark
DK002
Odense C, Denmark
FR006
Besançon, France
FR008
Limoges Cedex1, France
FR003
Nantes, France
FR001
Paris, France
FR005
Paris, France
FR004
Saint-Etienne, France
FR002
Toulouse, France
DE002
Berlin, Germany
DE006
Ellwangen, Germany
DE010
Günzburg, Germany
DE005
Hanover, Germany
DE007
Heidelberg, Germany
DE009
München, Germany
DE008
Ulm, Germany
DE004
Unterhaching, Germany
IT004
Ancona, Italy
IT006
Brescia, Italy
IT002
Florence, Italy
IT005
Genoa, Italy
IT003
Lamezia Terme, Italy
IT001
Milan, Italy
IT007
Palermo, Italy
PL004
Gliwice, Poland
PL007
Katowice, Poland
PL005
Poznan, Poland
PL006
Sopot, Poland
PL002
Szczecin, Poland
PL003
Warsaw, Poland
PL008
Wroclaw, Poland
RO002
Bucharest, Romania
RO001
Târgu Mureş, Romania
ZA003
Bloemfontein, South Africa
ZA006
Cape Town, South Africa
ZA007
Cape Town, South Africa
ZA004
George, South Africa
ZA005
Port Elizabeth, South Africa
ZA001
Pretoria, South Africa
ZA002
Rosebank, South Africa
ES002
Alicante, Spain
ES006
Barcelona, Spain
ES001
Donostia / San Sebastian, Spain
ES005
Manresa, Spain
ES004
Salamanca, Spain
ES003
Santiago de Compostela, Spain
UA008
Dnipropetrovsk, Ukraine
UA006
Kherson,Vil. Stepanivka, Ukraine
UA005
Kyiv, Ukraine
UA007
Kyiv, Ukraine
UA001
Lviv, Ukraine
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
September 27, 2013
First Posted
October 7, 2013
Study Start
October 1, 2013
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
September 19, 2017
Results First Posted
September 19, 2017
Record last verified: 2017-08