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

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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

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

Trial contacts and locations

107

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Data sourced from clinicaltrials.gov

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