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Alzheimer's DiseasePhase 3STAR ExtensionNCT02079246

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

A Phase 3 study testing Idalopirdine 60 mg in people with Alzheimer's Disease, run by H. Lundbeck A/S at 258 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Idalopirdine 60 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,463 participants
Where
258 sitesin 27 countries
Study dates
7 Apr 2014to 6 Jul 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
  • Other protocol-defined inclusion and exclusion criteria may apply.

Trial locations and contacts

258 sites in 27 countries.

258 sites in 27 countries

United States64 sites

  • US047

    Arlington, Virginia

  • US304

    Atlanta, Georgia

  • US360

    Augusta, Georgia

  • US027

    Birmingham, Alabama

  • US344

    Boston, Massachusetts

  • US021

    Bradenton, Florida

  • US050

    Brooksville, Florida

  • US351

    Carlsbad, California

  • US007

    Centerville, Ohio

  • US316

    Charlotte, North Carolina

  • US030

    Chicago, Illinois

  • US323

    Cincinnati, Ohio

  • US006

    Columbus, Ohio

  • US306

    Columbus, Ohio

  • US356

    Cordova, Tennessee

  • US346

    Costa Mesa, California

  • US308

    Delray Beach, Florida

  • US041

    Flowood, Mississippi

  • US343

    Fort Worth, Texas

  • US036

    Freeport, Maine

  • US327

    Fullerton, California

  • US320

    Hallandale, Florida

  • US321

    Hattiesburg, Mississippi

  • US347

    Hialeah, Florida

  • US354

    Houston, Texas

  • US023

    Imperial, California

  • US040

    Indianapolis, Indiana

  • US057

    Jenkintown, Pennsylvania

  • US048

    Kailua, Hawaii

  • US035

    Kalamazoo, Michigan

  • US334

    Lake Charles, Louisiana

  • US340

    Lake Worth, Florida

  • US352

    Lakewood, Ohio

  • US024

    Little Rock, Arkansas

  • US045

    Long Beach, California

  • US025

    Madison, Wisconsin

  • US014

    Manhasset, New York, 11030

  • US303

    Miami, Florida

  • US313

    Miami, Florida

  • US004

    Milwaukee, Wisconsin

  • US029

    New York, New York

  • US333

    Oklahoma City, Oklahoma

  • US345

    Orange City, Florida

  • US019

    Orlando, Florida

  • US309

    Palm Beach Gardens, Florida

  • US339

    Paterson, New Jersey

  • US012

    Phoenix, Arizona

  • US338

    Phoenix, Arizona

  • US324

    Pittsburgh, Pennsylvania

  • US341

    Pittsburgh, Pennsylvania

  • US038

    Port Charlotte, Florida

  • US319

    Port Royal, South Carolina

  • US026

    Portland, Oregon

  • US046

    Princeton, New Jersey

  • US307

    Redlands, California

  • US310

    Saint Paul, Minnesota

  • US058

    San Francisco, California

  • US018

    Santa Ana, California

  • US301

    Santa Rosa, California

  • US312

    Staten Island, New York

  • US302

    Sunrise, Florida

  • US028

    Toms River, New Jersey

  • US044

    Toms River, New Jersey

  • US336

    Winston-Salem, North Carolina

Other trials in United States

Argentina20 sites

  • AR303

    Banfield

  • AR007

    Buenos Aires

  • AR312

    Buenos Aires

  • AR003

    Ciudad Autonoma Buenos Aires

  • AR304

    Ciudad Autonoma Buenos Aires

  • AR308

    Ciudad Autonoma Buenos Aires

  • AR311

    Ciudad Autonoma Buenos Aires

  • AR313

    Ciudad Autonoma Buenos Aires

  • AR314

    Ciudad Autonoma Buenos Aires

  • AR009

    Córdoba

  • AR307

    Córdoba

  • AR309

    Córdoba

  • AR305

    Godoy Cruz

  • AR004

    Mar del Plata

  • AR005

    Mendoza

  • AR008

    Mendoza

  • AR310

    Mendoza

  • AR010

    Rosario

  • AR302

    Santa Fe

  • AR306

    Santiago del Estero

Other trials in Argentina

Italy18 sites

  • IT004

    Ancona

  • IT006

    Brescia

  • IT306

    Brescia

  • IT309

    Brescia

  • IT313

    Cefalù

  • IT002

    Florence

  • IT311

    Genova

  • IT003

    Lamezia Terme

  • IT001

    Milan

  • IT312

    Monza

  • IT005

    Palermo

  • IT007

    Palermo

  • IT307

    Perugia

  • IT301

    Pisa

  • IT305

    Roma

  • IT308

    Roma

  • IT304

    Torino

  • IT310

    Torrette

Other trials in Italy

France17 sites

  • FR006

    Besançon

  • FR301

    Bordeaux

  • FR308

    Bron

  • FR309

    Élancourt

  • FR008

    Limoges

  • FR302

    Marseille

  • FR003

    Nantes

  • FR312

    Nantes

  • FR303

    Nice

  • FR001

    Paris

  • FR005

    Paris

  • FR311

    Paris

  • FR306

    Reims

  • FR305

    Rouen

  • FR004

    Saint-Priest-en-Jarez

  • FR313

    Saint-Priest-en-Jarez

  • FR002

    Toulouse

Other trials in France

Poland17 sites

  • PL301

    Bialystok

  • PL304

    Bydgoszcz

  • PL308

    Gdynia

  • PL004

    Gliwice

  • PL007

    Katowice

  • PL309

    Krakow

  • PL302

    Lodz

  • PL310

    Lubin

  • PL306

    Lublin

  • PL307

    Oświęcim

  • PL005

    Późna

  • PL303

    Poznan

  • PL006

    Sopot

  • PL002

    Szczecin

  • PL311

    Szczecin

  • PL003

    Warsaw

  • PL008

    Wroclaw

Other trials in Poland

Czechia13 sites

  • CZ006

    Brno

  • CZ309

    Choceň

  • CZ306

    Hradec Králové

  • CZ007

    Kutná Hora

  • CZ004

    Pardubice

  • CZ001

    Prague

  • CZ002

    Prague

  • CZ003

    Prague

  • CZ301

    Prague

  • CZ303

    Prague

  • CZ304

    Prague

  • CZ310

    Praha 10 - Strasnice

  • CZ005

    Rychnov nad Kněžnou

Other trials in Czechia

Canada12 sites

  • CA002

    Gatineau

  • CA309

    Gatineau

  • CA301

    Halifax

  • CA302

    Kelowna

  • CA006

    London

  • CA306

    Montreal

  • CA008

    Newmarket

  • CA304

    Qubec

  • CA001

    Toronto

  • CA305

    Toronto

  • CA308

    Toronto

  • CA307

    Verdun

Other trials in Canada

United Kingdom11 sites

  • GB307

    Amersham

  • GB301

    Glasgow

  • GB303

    London

  • GB308

    London

  • GB310

    London

  • GB306

    Plymouth

  • GB311

    Plymouth

  • GB309

    Prescot

  • GB305

    Preston

  • GB304

    Southampton

  • GB302

    Swindon

Other trials in United Kingdom

South Korea9 sites

  • KR303

    Busan

  • KR301

    Incheon

  • KR308

    Seongnam-si

  • KR302

    Seoul

  • KR304

    Seoul

  • KR305

    Seoul

  • KR306

    Seoul

  • KR307

    Seoul

  • KR309

    Seoul

Other trials in South Korea

Brazil8 sites

  • BR307

    Curitiba

  • BR309

    Curitiba

  • BR303

    Porto Alegre

  • BR301

    Rio de Janeiro

  • BR306

    Rio de Janeiro

  • BR302

    São Paulo

  • BR304

    São Paulo

  • BR308

    São Paulo

Other trials in Brazil

Germany7 sites

  • DE002

    Berlin

  • DE006

    Ellwangen

  • DE005

    Hanover

  • DE007

    Heidelberg

  • DE009

    München

  • DE008

    Ulm

  • DE004

    Unterhaching

Other trials in Germany

Bulgaria6 sites

  • BG005

    Plovdiv

  • BG001

    Sofia

  • BG002

    Sofia

  • BG003

    Sofia

  • BG004

    Sofia

  • BG006

    Sofia

Other trials in Bulgaria

South Africa6 sites

  • ZA003

    Bloemfontein

  • ZA006

    Cape Town

  • ZA007

    Cape Town

  • ZA004

    George

  • ZA001

    Pretoria

  • ZA002

    Rosebank

Other trials in South Africa

Spain6 sites

  • ES006

    Barcelona

  • ES001

    Donostia / San Sebastian

  • ES005

    Manresa

  • ES004

    Salamanca

  • ES002

    San Vicent del Raspeig

  • ES003

    Santiago de Compostela

Other trials in Spain

Belgium5 sites

  • BE003

    Bruges

  • BE002

    Brussels

  • BE004

    Brussels

  • BE005

    Leuven

  • BE001

    Roeselare

Other trials in Belgium

Chile5 sites

  • CL004

    Antofagasta

  • CL002

    Santiago

  • CL003

    Santiago

  • CL005

    Santiago

  • CL001

    Valdivia

Other trials in Chile

Ukraine5 sites

  • UA008

    Dnipropetrovsk

  • UA006

    Kherson

  • UA005

    Kyiv

  • UA007

    Kyiv

  • UA001

    Lviv

Other trials in Ukraine

Hungary4 sites

  • HU304

    Budapest

  • HU305

    Budapest

  • HU301

    Esztergom

  • HU302

    Szeged

Other trials in Hungary

Lithuania4 sites

  • LT302

    Kaunas

  • LT303

    Kaunas

  • LT301

    Vilnius

  • LT304

    Vilnius

Other trials in Lithuania

Croatia3 sites

  • HR304

    Zabok

  • HR301

    Zagreb

  • HR302

    Zagreb

Other trials in Croatia

Estonia3 sites

  • EE301

    Tallinn

  • EE303

    Tallinn

  • EE302

    Tartu

Other trials in Estonia

Finland3 sites

  • FI302

    Kuopio

  • FI303

    Oulu

  • FI301

    Turku

Other trials in Finland

Israel3 sites

  • IL302

    Haifa

  • IL303

    Holon

  • IL304

    Ramat Gan

Other trials in Israel

Taiwan3 sites

  • TW301

    Kaohsiung City

  • TW302

    Kaohsiung City

  • TW303

    Tainan

Other trials in Taiwan

Denmark2 sites

  • DK003

    Aarhus N

  • DK001

    Copenhagen

Other trials in Denmark

Portugal2 sites

  • PT301

    Amadora

  • PT302

    Coimbra

Other trials in Portugal

Romania2 sites

  • RO002

    Bucharest

  • RO001

    Târgu Mureş

Other trials in Romania

About this study

Official title: 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

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).

Read the detailed description

This is an interventional, multi-national, multi-site, open-label extension study in patients with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or 14862A (NCT02006641).

Patients received 28-weeks of open-label treatment with idalopirdine 60 mg/day (option to reduce to 30 mg/day) as adjunctive treatment to donepezil. Approximately 100 patients, who had completed the initial 28-week period (OLEX), were included in a 24 week open-label treatment period with memantine (OLEX-MEM) that evaluated the safety and tolerability of concomitant memantine therapy in patients who were already on a stable treatment with idalopirdine and donepezil and for whom memantine treatment was clinically indicated.

Being tested
Idalopirdine 60 mg
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Idalopirdine 60 mgDrug

    once daily, encapsulated tablets, orally

Study groups in NCT02079246
Study groupRoleWhat they receive
Idalopirdine (Lu AE58054) 60 mgExperimentalIdalopirdine 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.
Receives: Drug: Idalopirdine 60 mg
Idalopirdine 60 mg + memantineExperimentalIdalopirdine 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.
Receives: Drug: Idalopirdine 60 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline II (start of OLEX, week 0) to end of OLEX (week 28)

  2. 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).

    Measured: From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)

Secondary outcomes (6)

  1. Change in Cognition

    Change from Baseline II to Week 28 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score. The ADAS-cog is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).

    Measured: Baseline II (start of OLEX, Week 0) to Week 28

  2. Clinical Global Impression Score

    Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 28. The ADCS-CGIC is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening).

    Measured: Week 28

  3. Change in Daily Functioning

    Change from Baseline II to Week 28 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The ADCS-ADL23 is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability).

    Measured: Baseline II (start of OLEX, Week 0) to Week 28

  4. Change in Behavioural Disturbance

    Change from Baseline II to Week 28 in Neuropsychiatric Inventory (NPI) total score. The NPI is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome).

    Measured: Baseline II (start of OLEX, Week 0) to Week 28

  5. Change in Cognitive Aspects of Mental Function

    Change from Baseline II to Week 28 in Mini Mental State Examination (MMSE). The MMSE is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).

    Measured: Baseline II (start of OLEX, Week 0) to Week 28

  6. Change in Cognitive Aspects of Mental Function

    Change from Baseline III to Week 52 in Mini Mental State Examination (MMSE). The MMSE is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).

    Measured: Baseline III (start of OLEX-MEM, Week 28) to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2014 (estimated)
  2. Study start7 Apr 2014
  3. Primary completion6 Jul 2017
  4. Study completion6 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02079246
Sponsor's protocol ID
14861B
Other IDs
2013-000001-23
Acronym
STAR Extension
Status last verified
Aug 2018
First submitted
28 Feb 2014
Last updated
10 Aug 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Idalopirdine 60 mg in people with Alzheimer's Disease, run by H. Lundbeck A/S at 258 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 258 sites in United States, Argentina, Italy, France, Poland and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX (time frame: Baseline II (start of OLEX, week 0) to end of OLEX (week 28)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02079246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

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