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

NCT ID: NCT02006654

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 734 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-01-31

Brief Summary

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

Detailed 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).

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo adjunct to base treatment with an AChEI

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once daily, matching placebo capsules, orally

Idalopirdine 60 mg (or 30 mg)

Idalopirdine adjunct to base treatment with an AChEI

Group Type: EXPERIMENTAL

Idalopirdine

Intervention Type: DRUG

Once daily, encapsulated tablets, orally

Interventions

Placebo

Once daily, matching placebo capsules, orally

Intervention Type: DRUG

Idalopirdine

Once daily, encapsulated tablets, orally

Intervention Type: DRUG

Other Intervention Names

Lu AE58054

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

US612

Mesa, Arizona, United States

US625

Bellflower, California, United States

US626

Costa Mesa, California, United States

US604

Oxnard, California, United States

US627

Santa Ana, California, United States

US609

Danbury, Connecticut, United States

US614

Norwalk, Connecticut, United States

US608

Deerfield Beach, Florida, United States

US616

Hialeah, Florida, United States

US620

Miami, Florida, United States

US603

North Palm Beach, Florida, United States

US631

Port Charlotte, Florida, United States

US622

Elk Grove Village, Illinois, United States

US611

Elkhart, Indiana, United States

US606

Prairie Village, Kansas, United States

US601

Farmington Hills, Michigan, United States

US607

St Louis, Missouri, United States

US613

Lawrenceville, New Jersey, United States

US635

Paterson, New Jersey, United States

US630

Toms River, New Jersey, United States

US621

Albany, New York, United States

US632

Staten Island, New York, United States

US633

Charlotte, North Carolina, United States

US623

Oklahoma City, Oklahoma, United States

US618

Norristown, Pennsylvania, United States

US619

Houston, Texas, United States

AU603

Caulfield, , Australia

AU609

Glen Iris, , Australia

AU602

Heidelberg West, , Australia

AU604

Kanwal, , Australia

AU606

Newcastle, , Australia

AU601

West Perth, , Australia

AU610

Woodville South, , Australia

BR608

Belo Horizonte, , Brazil

BR609

Itapira, , Brazil

BR607

Rio de Janeiro, , Brazil

CZ602

Choceň, , Czechia

CZ608

Choceň, , Czechia

CZ605

Havlíčkův Brod, , Czechia

CZ606

Kladno, , Czechia

CZ603

Pilsen, , Czechia

CZ601

Prague, , Czechia

CZ604

Prague, , Czechia

CZ607

Praha 10 - Strasnice, , Czechia

DE612

Bad Homburg, , Germany

DE610

Bad Honnef, , Germany

DE609

Berlin, , Germany

DE617

Berlin, , Germany

DE604

Erbach im Odenwald, , Germany

DE611

Freiburg im Breisgau, , Germany

DE607

Gelsenkirchen, , Germany

DE605

Homburg, , Germany

DE608

Karlstadt am Main, , Germany

DE602

Mittweida, , Germany

DE601

Munich, , Germany

DE606

Rostock, , Germany

DE603

Ulm, , Germany

DE616

Unterhaching, , Germany

IL605

Bat Yam, , Israel

IL601

Haifa, , Israel

IL604

Holon, , Israel

IL602

Ramat Gan, , Israel

IL603

Tel Aviv, , Israel

MX602

México, , Mexico

MX601

Monterrey, , Mexico

MX603

Monterrey, , Mexico

MX604

Monterrey, , Mexico

MX605

Monterrey, , Mexico

MX606

Saltillo, , Mexico

RS602

Belgrade, , Serbia

RS603

Kragujevac, , Serbia

RS601

Novi Sad, , Serbia

SG601

Singapore, , Singapore

SG602

Singapore, , Singapore

SK601

Banská Bystrica, , Slovakia

SK603

Bratislava, , Slovakia

SK605

Bratislava, , Slovakia

SK604

Rimavská Sobota, , Slovakia

SK602

Svidník, , Slovakia

KR601

Seongnam-si, , South Korea

KR602

Seoul, , South Korea

KR603

Seoul, , South Korea

KR604

Seoul, , South Korea

ES601

Barcelona, , Spain

ES603

Barcelona, , Spain

ES604

Barcelona, , Spain

ES608

Barcelona, , Spain

ES611

Bilbao, , Spain

ES612

Burgos, , Spain

ES602

Lleida, , Spain

ES613

Madrid, , Spain

ES610

Sant Cugat del Vallès, , Spain

ES606

Seville, , Spain

ES605

Terrassa, , Spain

ES607

Valencia, , Spain

CH603

Biel, , Switzerland

CH605

Lausanne, , Switzerland

CH602

Les Acacias, , Switzerland

CH601

Schlieren, , Switzerland

TR602

Balova, , Turkey (Türkiye)

TR601

Istanbul, , Turkey (Türkiye)

TR603

Istanbul, , Turkey (Türkiye)

TR605

Istanbul, , Turkey (Türkiye)

TR606

Izmir, , Turkey (Türkiye)

TR607

Samsun, , Turkey (Türkiye)

GB601

Brentford, , United Kingdom

GB603

Northampton, , United Kingdom

Countries

United States; Australia; Brazil; Czechia; Germany; Israel; Mexico; Serbia; Singapore; Slovakia; South Korea; Spain; Switzerland; Turkey (Türkiye); United Kingdom

References

Ballard C, Atri A, Boneva N, Cummings JL, Frolich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.

Reference Type: DERIVED

PMID: 31193334 (View on PubMed)

Cummings JL, Atri A, Ballard C, Boneva N, Frolich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2.

Reference Type: DERIVED

PMID: 30474567 (View on PubMed)

Atri A, Frolich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.

Reference Type: DERIVED

PMID: 29318278 (View on PubMed)

Other Identifiers

2012-004765-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14863A

Identifier Type: -

Identifier Source: org_study_id