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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02006654




Registration number
NCT02006654
Ethics application status
Date submitted
5/12/2013
Date registered
10/12/2013
Date last updated
7/02/2018

Titles & IDs
Public title
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Scientific title
Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Secondary ID [1] 0 0
2012-004765-40
Secondary ID [2] 0 0
14863A
Universal Trial Number (UTN)
Trial acronym
STARBRIGHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Idalopirdine

Placebo comparator: Placebo - Placebo adjunct to base treatment with an AChEI

Experimental: Idalopirdine 60 mg (or 30 mg) - Idalopirdine adjunct to base treatment with an AChEI


Treatment: Drugs: Placebo
Once daily, matching placebo capsules, orally

Treatment: Drugs: Idalopirdine
Once daily, encapsulated tablets, orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Cognition
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Change in Global Impression
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Change in Daily Functioning
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Change in Behavioural Disturbance
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Change in Individual Behavioural Disturbance Items
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Clinical Improvement
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Clinical Worsening
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Change in Cognitive Aspects of Mental Function
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 0 0
Change in Health-related Quality of Life (EQ-5D) Utility Score
Timepoint [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
Change in Health-related Quality of Life (EQ-5D VAS)
Timepoint [10] 0 0
Baseline and Week 24

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
Accrual to date
Final
734
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AU603 - Caulfield
Recruitment hospital [2] 0 0
AU609 - Glen Iris
Recruitment hospital [3] 0 0
AU602 - Heidelberg West
Recruitment hospital [4] 0 0
AU604 - Kanwal
Recruitment hospital [5] 0 0
AU606 - Newcastle
Recruitment hospital [6] 0 0
AU601 - West Perth
Recruitment hospital [7] 0 0
AU610 - Woodville south
Recruitment postcode(s) [1] 0 0
- Caulfield
Recruitment postcode(s) [2] 0 0
- Glen Iris
Recruitment postcode(s) [3] 0 0
- Heidelberg West
Recruitment postcode(s) [4] 0 0
- Kanwal
Recruitment postcode(s) [5] 0 0
- Newcastle
Recruitment postcode(s) [6] 0 0
- West Perth
Recruitment postcode(s) [7] 0 0
- Woodville south
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
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United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
Brazil
State/province [16] 0 0
Belo Horizonte
Country [17] 0 0
Brazil
State/province [17] 0 0
Itapira
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio de Janeiro
Country [19] 0 0
Czechia
State/province [19] 0 0
Chocen
Country [20] 0 0
Czechia
State/province [20] 0 0
Havlickuv Brod
Country [21] 0 0
Czechia
State/province [21] 0 0
Kladno
Country [22] 0 0
Czechia
State/province [22] 0 0
Plzen
Country [23] 0 0
Czechia
State/province [23] 0 0
Prague
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 10 - Strasnice
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 6
Country [26] 0 0
Germany
State/province [26] 0 0
Bad Homburg
Country [27] 0 0
Germany
State/province [27] 0 0
Bad Honnef
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Erbach
Country [30] 0 0
Germany
State/province [30] 0 0
Freiburg
Country [31] 0 0
Germany
State/province [31] 0 0
Gelsenkirchen
Country [32] 0 0
Germany
State/province [32] 0 0
Homburg
Country [33] 0 0
Germany
State/province [33] 0 0
Karlstadt
Country [34] 0 0
Germany
State/province [34] 0 0
Mittweida
Country [35] 0 0
Germany
State/province [35] 0 0
Munich
Country [36] 0 0
Germany
State/province [36] 0 0
Rostock
Country [37] 0 0
Germany
State/province [37] 0 0
Ulm
Country [38] 0 0
Germany
State/province [38] 0 0
Unterhaching
Country [39] 0 0
Israel
State/province [39] 0 0
Bat Yam
Country [40] 0 0
Israel
State/province [40] 0 0
Haifa
Country [41] 0 0
Israel
State/province [41] 0 0
Holon
Country [42] 0 0
Israel
State/province [42] 0 0
Ramat Gan
Country [43] 0 0
Israel
State/province [43] 0 0
Tel Aviv
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seongnam-si
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Seoul
Country [46] 0 0
Mexico
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Mexico
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Mexico
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Monterrey
Country [48] 0 0
Mexico
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Saltillo
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Serbia
State/province [49] 0 0
Belgrade
Country [50] 0 0
Serbia
State/province [50] 0 0
Kragujevac
Country [51] 0 0
Serbia
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Novi Sad
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Singapore
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Singapore
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Rimavska Sobota
Country [56] 0 0
Slovakia
State/province [56] 0 0
Svidnik
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Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Bilbao
Country [59] 0 0
Spain
State/province [59] 0 0
Burgos
Country [60] 0 0
Spain
State/province [60] 0 0
Lleida
Country [61] 0 0
Spain
State/province [61] 0 0
Madrid
Country [62] 0 0
Spain
State/province [62] 0 0
Sant Cugat del Vallès
Country [63] 0 0
Spain
State/province [63] 0 0
Sevilla
Country [64] 0 0
Spain
State/province [64] 0 0
Terrassa
Country [65] 0 0
Spain
State/province [65] 0 0
Valencia
Country [66] 0 0
Switzerland
State/province [66] 0 0
Biel
Country [67] 0 0
Switzerland
State/province [67] 0 0
Lausanne
Country [68] 0 0
Switzerland
State/province [68] 0 0
Les Acacias
Country [69] 0 0
Switzerland
State/province [69] 0 0
Schlieren
Country [70] 0 0
Turkey
State/province [70] 0 0
Balova
Country [71] 0 0
Turkey
State/province [71] 0 0
Istanbul
Country [72] 0 0
Turkey
State/province [72] 0 0
Izmir
Country [73] 0 0
Turkey
State/province [73] 0 0
Samsun
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Brentford
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Northampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
H. Lundbeck A/S
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Otsuka Pharmaceutical Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02006654
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
[email protected]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02006654