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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
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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
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Secondary ID [1]
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2012-004765-40
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Secondary ID [2]
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14863A
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Universal Trial Number (UTN)
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Trial acronym
STARBRIGHT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Cognition
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [1]
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Change in Global Impression
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [2]
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Change in Daily Functioning
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Assessment method [2]
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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).
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Timepoint [2]
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Baseline and Week 24
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Secondary outcome [3]
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Change in Behavioural Disturbance
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Assessment method [3]
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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).
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Timepoint [3]
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Baseline and Week 24
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Secondary outcome [4]
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Change in Individual Behavioural Disturbance Items
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and Week 24
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Secondary outcome [5]
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Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and Week 24
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Secondary outcome [6]
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Clinical Improvement
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Assessment method [6]
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Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes \[change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4\])
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Timepoint [6]
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Week 24
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Secondary outcome [7]
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Clinical Worsening
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Assessment method [7]
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Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes \[change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4\])
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Timepoint [7]
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Week 24
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Secondary outcome [8]
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Change in Cognitive Aspects of Mental Function
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Assessment method [8]
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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).
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Timepoint [8]
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Baseline and Week 24
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Secondary outcome [9]
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Change in Health-related Quality of Life (EQ-5D) Utility Score
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline and Week 24
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Secondary outcome [10]
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Change in Health-related Quality of Life (EQ-5D VAS)
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Assessment method [10]
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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).
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Timepoint [10]
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Baseline and Week 24
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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.
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2017
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Sample size
Target
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Accrual to date
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Final
734
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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AU603 - Caulfield
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Recruitment hospital [2]
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AU609 - Glen Iris
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Recruitment hospital [3]
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AU602 - Heidelberg West
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Recruitment hospital [4]
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AU604 - Kanwal
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Recruitment hospital [5]
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AU606 - Newcastle
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Recruitment hospital [6]
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AU601 - West Perth
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Recruitment hospital [7]
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AU610 - Woodville south
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Recruitment postcode(s) [1]
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- Caulfield
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Recruitment postcode(s) [2]
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- Glen Iris
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Recruitment postcode(s) [3]
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- Heidelberg West
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Recruitment postcode(s) [4]
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- Kanwal
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- Newcastle
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Recruitment postcode(s) [6]
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- West Perth
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Recruitment postcode(s) [7]
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- Woodville south
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Recruitment outside Australia
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California
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Itapira
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Rio de Janeiro
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Chocen
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Rostock
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Ulm
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Unterhaching
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Bat Yam
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Israel
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Haifa
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Israel
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Holon
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Israel
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Ramat Gan
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Israel
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Serbia
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Rimavska Sobota
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Svidnik
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Valencia
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Biel
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Lausanne
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Les Acacias
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Schlieren
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Turkey
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Balova
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Turkey
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Istanbul
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Izmir
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Samsun
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Brentford
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United Kingdom
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Northampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
H. Lundbeck A/S
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Otsuka Pharmaceutical Co., Ltd.
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Address [1]
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/study/NCT02006654
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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.
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Public notes
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Contacts
Principal investigator
Name
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Email contact via H. Lundbeck A/S
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Address
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02006654
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