Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil

(STARBEAM Trial)

Recruiting in Palo Alto (17 mi)

+161 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: H. Lundbeck A/S

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Email contact via H. Lundbeck A/S

Principal Investigator

[e-mail]

Eligibility Criteria

Inclusion Criteria

The patient has probable AD.

The patient has mild to moderate AD.

Stable treatment with donepezil.

Treatment Details

Interventions

• Idalopirdine (Other)

Participant Groups

Group I: Idalopirdine 30 mg Experimental Treatment 1 Intervention

Idalopirdine adjunct to 10 mg Donepezil

Group II: Idalopirdine 10 mg Experimental Treatment 1 Intervention

Idalopirdine adjunct to 10 mg Donepezil

Group III: Placebo Placebo Group 1 Intervention

Placebo adjunct to 10 mg Donepezil

Who Is Running the Clinical Trial?

H. Lundbeck A/S

Lead Sponsor

Trials

332

Recruited

78,300+

Charl van Zyl

H. Lundbeck A/S

Chief Executive Officer since 2023

Degree in Medical Biochemistry from the University of Cape Town, South Africa

Johan Luthman

H. Lundbeck A/S

Chief Medical Officer since 2019

MD from the University of Gothenburg, Sweden

Otsuka Pharmaceutical Co., Ltd.

Industry Sponsor

Trials

206

Recruited

97,700+

Tarek Rabah

Otsuka Pharmaceutical Co., Ltd.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University

John Kraus

Otsuka Pharmaceutical Co., Ltd.

Chief Medical Officer since 2021

MD and PhD in Neurobiology from Duke University