Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor (STARBRIGHT)

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Idalopirdine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02006654

14863A

2012-004765-40 (EudraCT Number)

Details and patient eligibility

About

To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).

Full description

The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 60mg/day as adjunctive therapy to an acetylcholinesterase inhibitor (donepezil 10mg/day, rivastigmine at the patient's individual maintenance dose, or galantamine at the patient's individual maintenance dose), and a 4-week safety follow-up period following study completion or withdrawal from treatment. The dose could be decreased once during the study to 30mg/day if 60mg/day was not well tolerated in the opinion of the investigator. The dose could be increased again to 60mg/day, after which the dose was kept fixed for the remainder of the study. Dose changes were permitted until Week 12 (Visit 5).

Enrollment: 734 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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 an AChEI.
• 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 current AChEI 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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734 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo adjunct to base treatment with an AChEI

Treatment:

Drug: Placebo

Idalopirdine 60 mg (or 30 mg)

Experimental group

Description:

Idalopirdine adjunct to base treatment with an AChEI

Treatment:

Drug: Idalopirdine