NCT02079246|CompletedPhase 3ResultsDMC

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

STAR Extension

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

H. Lundbeck A/S ClinicalTrials.gov

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2 other identifiers

14861B2013-000001-23

Study Type

interventional

Target

1,463

Locations

26 countries

Sites

252

Timeline

RegisteredMar 2014

StartedApr 2014

CompletionJul 2017

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,463

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Apr 2014

Typical duration for phase_3

Geographic Reach

26 countries

252 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

First Submitted

Initial submission to the registry

February 28, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed

1 month until next milestone

Study Start

First participant enrolled

April 7, 2014

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2017

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

August 10, 2018

Completed

Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

3.2 years

First QC Date

February 28, 2014

Results QC Date

July 6, 2018

Last Update Submit

August 9, 2018

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.
Baseline II (start of OLEX, week 0) to end of OLEX (week 28)
Number of TEAEs in the OLEX-MEM
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM).
From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)

Secondary Outcomes (6)

Change in Cognition
Baseline II (start of OLEX, Week 0) to Week 28
Clinical Global Impression Score
Week 28
Change in Daily Functioning
Baseline II (start of OLEX, Week 0) to Week 28
Change in Behavioural Disturbance
Baseline II (start of OLEX, Week 0) to Week 28
Change in Cognitive Aspects of Mental Function
Baseline II (start of OLEX, Week 0) to Week 28
+1 more secondary outcomes

Study Arms (2)

Idalopirdine (Lu AE58054) 60 mg

EXPERIMENTAL

Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.

Drug: Idalopirdine 60 mg

Idalopirdine 60 mg + memantine

EXPERIMENTAL

Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.

Drug: Idalopirdine 60 mg

Interventions

Idalopirdine 60 mgDRUG

once daily, encapsulated tablets, orally

Idalopirdine (Lu AE58054) 60 mgIdalopirdine 60 mg + memantine

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

H. Lundbeck A/Slead

Study Sites (258)

US027

Birmingham, Alabama, United States

Location

US012

Phoenix, Arizona, United States

Location

US338

Phoenix, Arizona, United States

Location

US024

Little Rock, Arkansas, United States

Location

US351

Carlsbad, California, United States

Location

US346

Costa Mesa, California, United States

Location

US327

Fullerton, California, United States

Location

US023

Imperial, California, United States

Location

US045

Long Beach, California, United States

Location

US307

Redlands, California, United States

Location

US058

San Francisco, California, United States

Location

US018

Santa Ana, California, United States

Location

US301

Santa Rosa, California, United States

Location

US021

Bradenton, Florida, United States

Location

US050

Brooksville, Florida, United States

Location

US308

Delray Beach, Florida, United States

Location

US320

Hallandale, Florida, United States

Location

US347

Hialeah, Florida, United States

Location

US340

Lake Worth, Florida, United States

Location

US303

Miami, Florida, United States

Location

US313

Miami, Florida, United States

Location

US345

Orange City, Florida, United States

Location

US019

Orlando, Florida, United States

Location

US309

Palm Beach Gardens, Florida, United States

Location

US038

Port Charlotte, Florida, United States

Location

US302

Sunrise, Florida, United States

Location

US304

Atlanta, Georgia, United States

Location

US360

Augusta, Georgia, United States

Location

US048

Kailua, Hawaii, United States

Location

US030

Chicago, Illinois, United States

Location

US040

Indianapolis, Indiana, United States

Location

US334

Lake Charles, Louisiana, United States

Location

US036

Freeport, Maine, United States

Location

US344

Boston, Massachusetts, United States

Location

US035

Kalamazoo, Michigan, United States

Location

US310

Saint Paul, Minnesota, United States

Location

US041

Flowood, Mississippi, United States

Location

US321

Hattiesburg, Mississippi, United States

Location

US339

Paterson, New Jersey, United States

Location

US046

Princeton, New Jersey, United States

Location

US028

Toms River, New Jersey, United States

Location

US044

Toms River, New Jersey, United States

Location

US014

Manhasset, New York, 11030, United States

Location

US029

New York, New York, United States

Location

US312

Staten Island, New York, United States

Location

US316

Charlotte, North Carolina, United States

Location

US336

Winston-Salem, North Carolina, United States

Location

US007

Centerville, Ohio, United States

Location

US323

Cincinnati, Ohio, United States

Location

US006

Columbus, Ohio, United States

Location

US306

Columbus, Ohio, United States

Location

US352

Lakewood, Ohio, United States

Location

US333

Oklahoma City, Oklahoma, United States

Location

US026

Portland, Oregon, United States

Location

US057

Jenkintown, Pennsylvania, United States

Location

US324

Pittsburgh, Pennsylvania, United States

Location

US341

Pittsburgh, Pennsylvania, United States

Location

US319

Port Royal, South Carolina, United States

Location

US356

Cordova, Tennessee, United States

Location

US343

Fort Worth, Texas, United States

Location

US354

Houston, Texas, United States

Location

US047

Arlington, Virginia, United States

Location

US025

Madison, Wisconsin, United States

Location

US004

Milwaukee, Wisconsin, United States

Location

AR303

Banfield, Argentina

Location

AR007

Buenos Aires, Argentina

Location

AR312

Buenos Aires, Argentina

Location

AR003