Alzheimer´s disease MedDRA version: 18.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Interventions
Product Name: Idalopirdine
Product Code: Lu AE58054
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Idalopirdine
Current Sponsor code: Lu AE58054
Concentration unit: mg milligram(s)
Conce
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Open-label treatment period (initial 28 weeks): • The patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A or 14862A. Open-label treatment period with memantine (sub-study): Major inclusion criteria at Baseline III: * The patient has completed Visit 6 [(i.e., the open-label treatment period (initial 28-week period)]. * The patient has a MMSE score at Visit 6 not greater than 19 in accordance with the memantine label/summary of product characteristics (SmPC). * The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per locallabei/SmPC/treatment guidelines. 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 265 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1505
Exclusion criteria
Exclusion criteria: • The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator. • The patient has experienced seizures before Completion Visit in the lead-in study. • The patient has evidence of clinically significant disease. • The patient's donepezil treatment is likely to be interrupted or discontinued during the study. • The patient is receiving therapy with another AChEI or memantine. Open-label treatment period with memantine (sub-study): Major exclusion criteria at Baseline III: * The patient exhibits an increase in MMSE score by 3 points or more at Visit 6 from Baseline II. * The patient has a moderate or severe on-going adverse event from the open-label treatment period (initial 28-week period) considered a potential safety risk by the investigator. * The patient has a previous history of testing positive for hepatitis B surface antigen (HBsAg), or hepatitis C virus / antibodies (anti-HCV) AND had abnormal ALT, AST or bilirubin during the open-label treatment period (initial 28-week period). * The patient has tested positive for hepatitis B surface antigen (HBsAg), or hepatitis C virus /antibodies (anti-HCV) for the frrst time within the last 6 months prior to the Visit 6 in the open-label treatment period (initial 28-week period). * The patient has one or more clinical laboratory test values outside the reference range, based on the latest available blood and urine sample results during the open-label treatment period (initial 28-week period), that are of potential risk to the patient's safety, or the patient has according to the latest available blood sample: - a serum creatinine value >1.5 times the upper limit of the reference range, or - a serum total bilirubin value >1.5 times the upper limit of the reference range, or - a serum alanine aminotransferase (AL T) or aspartate aminotransferase (AST) value >2 times the upper limit ofthe reference range.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Open-label treatment period (initial 28 weeks): To evaluate the long-term safety and tolerability of idalopirdine as adjunctive therapy to donepezil in patients with mild-moderate AD. Open-label treatment period with memantine (sub-study): To evaluate the safety and tolerability of concomitant treatment with idalopirdine, memantine and donepezil in patients with AD.;Secondary Objective: Open-label treatment period (initial 28 weeks): To evaluate the disease development during long-term treatment with idalopirdine as adjunctive therapy to donepezil. Open-label treatment period with memantine (sub-study): To evaluate the disease development during concomitant treatment with idalopirdine, memantine and donepezil in patients with AD.;Primary end point(s): • Safety: Number of adverse events • Tolerability: Number of withdrawals;Timepoint(s) of evaluation of this end point: Up to 28 weeks and a 4-week safety follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in cognition: Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score • 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 cognitive aspects of mental function: Change in Mini Mental State Examination (MMSE) • Risk of Suicidality Using C-SSRS Scores: Columbia Suicide Severity Rating Scale (C-SSRS);Timepoint(s) of evaluation of this end point: Baseline and Week 28 for all, except for Risk of Suicidality which is up to week 28. | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Korea, Republic of, Lithuania, Poland, Portugal, Romania, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public Contactlundbeckclinicaltrials@lundbeck.com
H- Lundbeck A/S
Outcome results
None listed