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Lu AE58054 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil (STARBEAM)

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT02006641
First received: December 5, 2013
Last updated: May 30, 2017
Last verified: May 2017
December 5, 2013
May 30, 2017
February 2014
December 2016   (Final data collection date for primary outcome measure)
Change in cognition [ Time Frame: Baseline and Week 24 ]
Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score
Same as current
Complete list of historical versions of study NCT02006641 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Lu AE58054 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
To establish efficacy of Lu AE58054 as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Placebo
    Once daily, matching placebo capsules, orally
  • Drug: Lu AE58054
    Once daily, encapsulated tablets, orally
  • Placebo Comparator: Placebo
    Placebo adjunct to 10 mg Donepezil
    Intervention: Drug: Placebo
  • Experimental: Lu AE58054 10 mg
    Lu AE58054 adjunct to 10 mg Donepezil
    Intervention: Drug: Lu AE58054
  • Experimental: Lu AE58054 30 mg
    Lu AE58054 adjunct to 10 mg Donepezil
    Intervention: Drug: Lu AE58054
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
858
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, Senior)
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
May 2017

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