Alzheimer’s disease MedDRA version: 18.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Interventions
Product Code: Lu AE58054
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not available
Current Sponsor code: Lu AE58054
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion 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 is a man or woman, aged at least 50 years. • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 790
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish efficacy of Lu AE58054 as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-moderate Alzheimer’s disease;Secondary Objective: To investigate the effect of Lu AE58054 as adjunctive therapy to donepezil on neuropsychiatric symptoms in patients with mild-moderate Alzheimer’s disease;Primary end point(s): Change in cognition: Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.;Timepoint(s) of evaluation of this end point: Baseline and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in global impression: Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score • Change in functioning: Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score • Change in behavioural disturbance: Change in Neuropsychiatric Inventory (NPI) total score • Change in individual behavioural disturbance items: Change in single NPI item scores • Change in anxiety: Change in NPI Anxiety item score based on a prespecified NPI Anxiety score at Baseline • Clinical response: Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes • Clinical worsening: Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes • Change in cognitive aspects of mental function: Change in Mini Mental State Examination (MMSE) • Change in health-related quality of life: Change in EuroQol 5-dimensional (EQ-5D) utility score • Change in health-related quality of life: Change in EQ-5D Visual Analogue Scale (EQ-5D VAS);Timepoint(s) of evaluation of this end point: Baseline and Week 24 | — |
Countries
Argentina, Belgium, Bulgaria, Canada, Chile, Czech Republic, Denmark, France, Germany, Italy, Poland, Romania, South Africa, Spain, Ukraine, United States
Contacts
Public Contactlundbeckclinicaltrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed