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Lu AE58054 in Patients With Mild to Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor (STARBRIGHT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by H. Lundbeck A/S
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT02006654
First received: December 5, 2013
Last updated: October 3, 2014
Last verified: March 2014
  Purpose

To establish efficacy of Lu AE58054 as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Lu AE58054 in Patients With Mild to Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score

  • Change in functioning [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in Neuropsychiatric Inventory (NPI) total score

  • Change in individual behavioural disturbance items [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Change in single NPI item scores

  • Change in anxiety [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Change in NPI Anxiety item score based on a pre-specified NPI Anxiety score at Baseline

  • Clinical response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes

  • Clinical worsening [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in Mini Mental State Examination (MMSE)

  • Change in health-related quality of life (EQ-5D) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Change in EuroQol 5-dimensional (EQ-5D) utility score

  • Change in health-related quality of (EQ-5D VAS) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Change in EQ-5D Visual Analogue Scale (EQ-5D VAS)

  • Number of patients with adverse events (AEs) [ Time Frame: Up to 24 weeks and a 4-week safety follow up ] [ Designated as safety issue: Yes ]
    Overview of AEs

  • Proportion of patients who withdrew due to intolerance to treatment [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
  • Risk of suicidality [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    Columbia Suicide Severity Rating Scale (C-SSRS)


Estimated Enrollment: 720
Study Start Date: March 2014
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo adjunct to base treatment with an AChEI
Drug: Placebo
Once daily, matching placebo capsules, orally
Experimental: Lu AE58054 60 mg (or 30 mg)
Lu AE58054 adjunct to base treatment with an ACHEI
Drug: Lu AE58054
Once daily, encapsulated tablets, orally

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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 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.

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.

  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: NCT02006654

Contacts
Contact: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

  Show 95 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

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02006654     History of Changes
Other Study ID Numbers: 14863A, 2012-004765-40
Study First Received: December 5, 2013
Last Updated: October 3, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
Korea: Food and Drug Administration
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014