Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatments placebo, lu ae58054
Phase phase 3
Sponsor H. Lundbeck A/S
Collaborator Otsuka Pharmaceutical Co., Ltd.
Start date February 2014
End date March 2017
Trial size 858 participants
Trial identifier NCT02006641, 14862A, 2012-004764-22

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo adjunct to 10 mg Donepezil
placebo
Once daily, matching placebo capsules, orally
(Experimental)
Lu AE58054 adjunct to 10 mg Donepezil
lu ae58054
Once daily, encapsulated tablets, orally
(Experimental)
Lu AE58054 adjunct to 10 mg Donepezil
lu ae58054
Once daily, encapsulated tablets, orally

Primary Outcomes

Measure
Change in cognition
time frame: Baseline and Week 24

Secondary Outcomes

Measure
Change in global impression
time frame: Baseline and Week 24
Change in functioning
time frame: Baseline and Week 24
Change in behavioural disturbance
time frame: Baseline and Week 24
Change in individual behavioural disturbance items
time frame: Baseline and Week 24
Change in anxiety
time frame: Baseline and Week 24
Clinical response
time frame: Week 24
Clinical worsening
time frame: Week 24
Change in cognitive aspects of mental function
time frame: Baseline and Week 24
Change in health-related quality of life (EQ-5D-3L)
time frame: Baseline and Week 24
Change in health-related quality of (EQ-5D-3L VAS)
time frame: Baseline and Week 24
Number of patients with adverse events (AEs)
time frame: Up to 24 weeks and a 4-week safety follow up
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

Eligibility Criteria

Male or female participants at least 50 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by H. Lundbeck A/S.