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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
  Purpose
To establish efficacy of Lu AE58054 as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

Condition Intervention Phase
Alzheimer's Disease Drug: Placebo Drug: Lu AE58054 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Change in cognition [ Time Frame: Baseline and Week 24 ]
    Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score


Secondary Outcome Measures:
  • 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)


Enrollment: 858
Study Start Date: February 2014
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo adjunct to 10 mg Donepezil
Drug: Placebo
Once daily, matching placebo capsules, orally
Experimental: Lu AE58054 10 mg
Lu AE58054 adjunct to 10 mg Donepezil
Drug: Lu AE58054
Once daily, encapsulated tablets, orally
Experimental: Lu AE58054 30 mg
Lu AE58054 adjunct to 10 mg Donepezil
Drug: Lu AE58054
Once daily, encapsulated tablets, orally

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006641

  Show 162 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02006641     History of Changes
Other Study ID Numbers: 14862A
2012-004764-22 ( EudraCT Number )
Study First Received: December 5, 2013
Last Updated: May 30, 2017

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents

ClinicalTrials.gov processed this record on August 17, 2017