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Study of Lu AE58054 in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil (STARSHINE)

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01955161
First received: September 27, 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: 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.

    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).



Secondary Outcome Measures:
  • Change in daily functioning [ Time Frame: Baseline and Week 24 ]

    Change 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 ADL. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower impairment).


  • Change in global impression [ Time Frame: Baseline and Week 24 ]

    Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score.

    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 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]), severity (a 3-point scale from 1 [mild] to 3 [marked]), and caregiver distress (a 5-point scale from 0 [not at all] to 5 [very severely or extremely]). Total score of the frequency ratings multiplied by the severity ratings ranges from 0 to 144 and the total score of the caregiver distress ratings ranges from 0 to 60.


  • Change in individual behavioural disturbance items [ Time Frame: Baseline and Week 24 ]
    Change in single NPI item scores

  • Change in individual behavioural disturbance items in patients with an item score of at least 2 at baseline [ Time Frame: Baseline and Week 24 ]
    Change in NPI single item scores in patients with an item score of at least 2 at baseline

  • Emergence of individual behavioural disturbance items [ Time Frame: Baseline and Week 24 ]
    Emergence of NPI single items (score above or equal to 3) at Week 24 in patients with an item score of <3 at baseline

  • Change in caregiver distress [ Time Frame: Baseline and Week 24 ]
    Change in NPI caregiver distress total score

  • Clinical improvement [ 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). 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).

  • Cumulative change in cognition [ Time Frame: Baseline to Week 24 ]
    Area under the curve for the change from baseline in ADAS-cog

  • Cumulative change in daily functioning [ Time Frame: Baseline to Week 24 ]
    Area under the curve for the change from baseline in ADCS-ADL23

  • Cumulative change in global impression [ Time Frame: Baseline to Week 24 ]
    Area under the curve for the change from baseline in ADCS-CGIC

  • Change in cognition and daily function [ Time Frame: Baseline and Week 24 ]
    Change in ADAS-cog and ADCS-ADL23 composite score

  • Cumulative change in cognition and daily function [ Time Frame: Baseline to Week 24 ]
    Area under the curve for the change from baseline in ADAS-cog and ADCS-ADL23 composite score

  • Change in basic activities of daily functioning [ Time Frame: Baseline and Week 24 ]
    Change in basic ADCS-ADL23

  • Change in instrumental activities of daily functioning [ Time Frame: Baseline and Week 24 ]
    Change in instrumental ADCS-ADL23

  • Change in dependence level [ Time Frame: Baseline and Week 24 ]

    Change in dependence level score (based on the Dependence Scale).

    The Dependence Scale consists of 13 questions on social and occupational functioning to assess dependence as a measure of health in AD. Two questions are rated by frequency (no, occasionally, frequently) and the remaining 11 questions have 'yes' or 'no' responses. The answers are used to derive a dependence level from 0 (no dependence) to 5 (complete dependence). Total score ranges from 0 to 15.


  • Change in health-related quality of life (EQ-5D) [ Time Frame: Baseline and Week 24 ]
    Change in EuroQol 5-dimensional (EQ-5D) utility score

  • Change in health-related quality of (EQ-5D VAS) [ Time Frame: Baseline and Week 24 ]
    Change in EQ-5D Visual Analogue Scale (EQ-5D VAS)


Enrollment: 933
Study Start Date: October 2013
Study Completion Date: July 2016
Primary Completion Date: July 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 30 mg
Lu AE58054 adjunct to 10 mg Donepezil
Drug: Lu AE58054
Once daily, encapsulated tablets, orally
Experimental: Lu AE58054 60 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: NCT01955161

  Show 137 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: NCT01955161     History of Changes
Other Study ID Numbers: 14861A
2012-004763-45 ( EudraCT Number )
Study First Received: September 27, 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 June 26, 2017