Phase 3 N=1,463 Treatment

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

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02079246 ↗

Enrolled (actual)

1,463

Serious AEs

5.9%

Results posted

Aug 2018

Primary outcome: Primary: Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX — 2130 TEAEs

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Idalopirdine 60 mg (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: H. Lundbeck A/S
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX	2130	—
PRIMARY Number of TEAEs in the OLEX-MEM	93	—
SECONDARY Change in Cognition	3.01; 2.67	—
SECONDARY Clinical Global Impression Score	4.58; 4.61	—
SECONDARY Change in Daily Functioning	-3.71; -3.88	—
SECONDARY Change in Behavioural Disturbance	1.80; 1.36	—
SECONDARY Change in Cognitive Aspects of Mental Function	-0.55	—
SECONDARY Change in Cognitive Aspects of Mental Function	-0.55	—

Summary

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).

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02079246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.