Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

Phase 3CompletedNCT02079246

H. Lundbeck A/S1,463 enrolled

Overview

To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).

This is an interventional, multi-national, multi-site, open-label extension study in patients with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or 14862A (NCT02006641). Patients received 28-weeks of open-label treatment with idalopirdine 60 mg/day (option to reduce to 30 mg/day) as adjunctive treatment to donepezil. Approximately 100 patients, who had completed the initial 28-week period (OLEX), were included in a 24 week open-label treatment period with memantine (OLEX-MEM) that evaluated the safety and tolerability of concomitant memantine therapy in patients who were already on a stable treatment with idalopirdine and donepezil and for whom memantine treatment was clinically indicated.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,463

Conditions

Alzheimer's Disease

Interventions

Idalopirdine 60 mgDRUG

once daily, encapsulated tablets, orally

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641 For patients in the OLEX-MEM: * The patient has completed Visit 6 (Week 28) of the OLEX. * The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/SmPC/treatment guidelines. 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 acetylcholinesterase inhibitors (AChEI). Other protocol-defined inclusion and exclusion criteria may apply.

Locations (258)

Outcomes

Primary Outcomes

Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX

A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.

Time frame: Baseline II (start of OLEX, week 0) to end of OLEX (week 28)

Number of TEAEs in the OLEX-MEM

A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM).

Time frame: From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)

Secondary Outcomes

Change in Cognition

Change from Baseline II to Week 28 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score. The 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).

Time frame: Baseline II (start of OLEX, Week 0) to Week 28

Clinical Global Impression Score

Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 28. The ADCS-CGIC 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).

Time frame: Week 28

Change in Daily Functioning

Change from Baseline II to Week 28 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The 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 activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability).

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Carlsbad, California, United States

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Costa Mesa, California, United States

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Fullerton, California, United States

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Imperial, California, United States

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Long Beach, California, United States

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Redlands, California, United States

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