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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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).
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
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).
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
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.
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 - 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.
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
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])
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
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])
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
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).
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
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).
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [13] 0 0
United States of America
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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
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Germany
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Bad Honnef
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Germany
State/province [28] 0 0
Berlin
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Germany
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Erbach
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Germany
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Freiburg
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Germany
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Gelsenkirchen
Country [32] 0 0
Germany
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Homburg
Country [33] 0 0
Germany
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Karlstadt
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Germany
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Mittweida
Country [35] 0 0
Germany
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Munich
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Germany
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Rostock
Country [37] 0 0
Germany
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Ulm
Country [38] 0 0
Germany
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Unterhaching
Country [39] 0 0
Israel
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Bat Yam
Country [40] 0 0
Israel
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Haifa
Country [41] 0 0
Israel
State/province [41] 0 0
Holon
Country [42] 0 0
Israel
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Ramat Gan
Country [43] 0 0
Israel
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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
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Mexico
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Mexico
Country [47] 0 0
Mexico
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Monterrey
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Mexico
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Saltillo
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Serbia
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Belgrade
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Serbia
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Kragujevac
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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
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Slovakia
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Svidnik
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Burgos
Country [60] 0 0
Spain
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Lleida
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Spain
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Madrid
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Spain
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Sant Cugat del Vallès
Country [63] 0 0
Spain
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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
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Lausanne
Country [68] 0 0
Switzerland
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Les Acacias
Country [69] 0 0
Switzerland
State/province [69] 0 0
Schlieren
Country [70] 0 0
Turkey
State/province [70] 0 0
Balova
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Samsun
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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/show/NCT02006654
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
LundbeckClinicalTrials@lundbeck.com
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
Other publications