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Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil (STARBEAM)

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ClinicalTrials.gov Identifier: NCT02006641
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

December 5, 2013
December 10, 2013
December 19, 2017
February 20, 2018
February 20, 2018
February 2014
December 2016   (Final data collection date for primary outcome measure)
Change in Cognition [ Time Frame: Baseline and Week 24 ]

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).

Change in Cognition [ Time Frame: Baseline and Week 24 ]
Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score
Complete list of historical versions of study NCT02006641 on ClinicalTrials.gov Archive Site
  • Change in Daily Functioning [ Time Frame: Baseline and Week 24 ]

    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).

  • Change in Global Impression [ Time Frame: Baseline and Week 24 ]

    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).

  • Change in Behavioural Disturbance [ Time Frame: Baseline and Week 24 ]

    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 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).

  • Change in Individual Behavioural Disturbance Items [ Time Frame: Baseline and Week 24 ]

    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.

  • Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline [ Time Frame: Baseline and Week 24 ]

    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.

  • Number of Participants With Clinical Improvement [ Time Frame: Week 24 ]
    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])
  • Number of Participants With Clinical Worsening [ Time Frame: Week 24 ]
    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])
  • Change in Cognitive Aspects of Mental Function [ Time Frame: Baseline and Week 24 ]
    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).
  • Change in Health-related Quality of Life (EQ-5D) Utility Score [ Time Frame: Baseline and Week 24 ]

    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.

  • Change in Health-related Quality of Life (EQ-5D VAS) [ Time Frame: Baseline and Week 24 ]

    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).

  • Change in Global Impression [ Time Frame: Baseline and Week 24 ]
    Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score
  • Change in functioning [ Time Frame: Baseline and Week 24 ]
    Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score
  • Change in Behavioural Disturbance [ Time Frame: Baseline and Week 24 ]
    Change in Neuropsychiatric Inventory (NPI) total score
  • Change in Individual Behavioural Disturbance Items [ Time Frame: Baseline and Week 24 ]
    Change in single NPI item scores
  • Change in anxiety [ Time Frame: Baseline and Week 24 ]
    Change in NPI Anxiety item score based on a pre-specified NPI Anxiety score at Baseline
  • Clinical response [ Time Frame: Week 24 ]
    Based on pre-specified ADAS-Cog, ADCS-ADL23, and ADCS-CGIC changes
  • Clinical worsening [ Time Frame: Week 24 ]
    Based on pre-specified ADAS-Cog, ADCS-ADL23, and ADCS-CGIC changes
  • Change in cognitive aspects of mental function [ Time Frame: Baseline and Week 24 ]
    Change in Mini Mental State Examination (MMSE)
  • Change in health-related quality of life (EQ-5D-3L) [ Time Frame: Baseline and Week 24 ]
    Change in EuroQol 5-dimensional 3-layer (EQ-5D-3L), a measure of health-related quality of life
  • Change in health-related quality of (EQ-5D-3L VAS) [ Time Frame: Baseline and Week 24 ]
    Change in EQ-5D-3L Visual Analogue Scale (EQ-5D-3L VAS)
  • Number of patients with adverse events (AEs) [ Time Frame: Up to 24 weeks and a 4-week safety follow up ]
    Overview of AEs
  • Proportion of patients who withdrew due to intolerance to treatment [ Time Frame: Baseline to Week 24 ]
  • Risk of suicidality [ Time Frame: Up to 24 weeks ]
    Columbia Suicide Severity Rating Scale (C-SSRS)
Not Provided
Not Provided
 
Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).
The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 10 mg/day or 30 mg/day as adjunctive therapy to donepezil 10 mg/day, and a 4-week safety follow-up period following study completion or withdrawal from treatment.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Placebo
    Once daily, matching placebo capsules, orally
  • Drug: Idalopirdine
    Once daily, encapsulated tablets, orally
    Other Name: Lu AE58054
  • Placebo Comparator: Placebo
    Placebo adjunct to 10 mg Donepezil
    Intervention: Drug: Placebo
  • Experimental: Idalopirdine 10 mg
    Idalopirdine adjunct to 10 mg Donepezil
    Intervention: Drug: Idalopirdine
  • Experimental: Idalopirdine 30 mg
    Idalopirdine adjunct to 10 mg Donepezil
    Intervention: Drug: Idalopirdine
Atri A, Frölich 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
858
840
December 2016
December 2016   (Final data collection date for primary outcome measure)

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 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.

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 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.

Other inclusion and exclusion criteria may apply.

Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Canada,   Croatia,   Czechia,   Estonia,   Finland,   France,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Poland,   Portugal,   Taiwan,   United Kingdom,   United States
Czech Republic
 
NCT02006641
14862A
2012-004764-22 ( EudraCT Number )
Yes
Not Provided
Not Provided
H. Lundbeck A/S
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP