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Alzheimer's DiseasePhase 3STARBEAMNCT02006641

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

A Phase 3 study testing Idalopirdine in people with Alzheimer's Disease, run by H. Lundbeck A/S at 162 sites in 19 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 establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
858 participants
Where
162 sitesin 19 countries
Study dates
Feb 2014to Dec 2016
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 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 donepezil.
  • 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.

Who cannot join

  • 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 donepezil 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 locations and contacts

162 sites in 19 countries.

162 sites in 19 countries

United States48 sites

  • US314

    Allentown, Pennsylvania

  • US322

    Anaheim, California

  • US304

    Atlanta, Georgia

  • US360

    Augusta, Georgia

  • US350

    Belmont, Massachusetts

  • US344

    Boston, Massachusetts

  • US305

    Carson, California

  • US316

    Charlotte, North Carolina

  • US323

    Cincinnati, Ohio

  • US349

    Cleveland, Ohio

  • US306

    Columbus, Ohio

  • US356

    Cordova, Tennessee

  • US346

    Costa Mesa, California

  • US330

    Creve Coeur, Missouri

  • US318

    Decatur, Georgia

  • US308

    Delray Beach, Florida

  • US342

    Fayetteville, Arkansas

  • US343

    Fort Worth, Texas

  • US327

    Fullerton, California

  • US320

    Hallandale, Florida

  • US321

    Hattiesburg, Mississippi

  • US347

    Hialeah, Florida

  • US354

    Houston, Texas

  • US334

    Lake Charles, Louisiana

  • US340

    Lake Worth, Florida

  • US352

    Lakewood, Ohio

  • US315

    Lomita, California

  • US303

    Miami, Florida

  • US313

    Miami, Florida

  • US335

    Naples, Florida

  • US337

    New London, Connecticut

  • US351

    Oceanside, California

  • US333

    Oklahoma City, Oklahoma

  • US345

    Orange City, Florida

  • US309

    Palm Beach Gardens, Florida

  • US339

    Paterson, New Jersey

  • US338

    Phoenix, Arizona

  • US324

    Pittsburgh, Pennsylvania

  • US341

    Pittsburgh, Pennsylvania

  • US319

    Port Royal, South Carolina

  • US325

    Reading, Pennsylvania

  • US307

    Redlands, California

  • US310

    Saint Paul, Minnesota

  • US301

    Santa Rosa, California

  • US332

    Stamford, Connecticut

  • US312

    Staten Island, New York

  • US302

    Sunrise, Florida

  • US336

    Winston-Salem, North Carolina

Other trials in United States

Argentina15 sites

  • AR303

    Banfield

  • AR312

    Buenos Aires

  • AR301

    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

  • AR315

    Ciudad Autonoma Buenos Aires

  • AR307

    Córdoba

  • AR309

    Córdoba

  • AR305

    Godoy Cruz

  • AR310

    Mendoza

  • AR302

    Santa Fe

  • AR306

    Santiago del Estero

Other trials in Argentina

Italy12 sites

  • IT306

    Brescia

  • IT309

    Brescia

  • IT311

    Genova

  • IT312

    Monza

  • IT302

    Naples

  • IT313

    Palermo

  • IT307

    Perugia

  • IT301

    Pisa

  • IT305

    Roma

  • IT308

    Roma

  • IT304

    Torino

  • IT310

    Torrette

Other trials in Italy

Czechia10 sites

  • CZ305

    Brno

  • CZ306

    Choceň

  • CZ309

    Choceň

  • CZ308

    Pardubice

  • CZ301

    Prague

  • CZ303

    Prague

  • CZ304

    Prague

  • CZ307

    Prague

  • CZ310

    Praha 10 - Strasnice

  • CZ302

    Rychnov nad Kněžnou

Other trials in Czechia

France9 sites

  • FR301

    Bordeaux

  • FR308

    Bron

  • FR307

    Colmar

  • FR304

    Dijon

  • FR309

    Élancourt

  • FR302

    Marseille

  • FR303

    Nice

  • FR306

    Reims

  • FR305

    Rouen

Other trials in France

Poland9 sites

  • PL301

    Bialystok

  • PL304

    Bydgoszcz

  • PL308

    Gdynia

  • PL309

    Krakow

  • PL302

    Lodz

  • PL310

    Lubin

  • PL306

    Lublin

  • PL307

    Oświęcim

  • PL303

    Poznan

Other trials in Poland

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

United Kingdom9 sites

  • GB307

    Amersham

  • GB301

    Glasgow

  • GB303

    London

  • GB308

    London

  • GB306

    Plymouth

  • GB305

    Preston

  • GB304

    Southampton

  • GB302

    Swindon

  • GB309

    Warrington

Other trials in United Kingdom

Canada6 sites

  • CA301

    Halifax

  • CA302

    Kelowna

  • CA306

    Montreal

  • CA304

    Qubec

  • CA303

    Sherbrooke

  • CA305

    Toronto

Other trials in Canada

Brazil5 sites

  • BR307

    Curitiba

  • BR309

    Curitiba

  • BR301

    Rio de Janeiro

  • BR306

    Rio de Janeiro

  • BR308

    São Paulo

Other trials in Brazil

Hungary5 sites

  • HU304

    Budapest

  • HU305

    Budapest

  • HU301

    Esztergom

  • HU303

    Győr

  • HU302

    Szeged

Other trials in Hungary

Taiwan5 sites

  • TW301

    Kaohsiung City

  • TW302

    Kaohsiung City

  • TW303

    Taichung

  • TW304

    Taipei

  • TW305

    Taipei

Other trials in Taiwan

Croatia4 sites

  • HR304

    Zabok

  • HR301

    Zagreb

  • HR302

    Zagreb

  • HR303

    Zagreb

Other trials in Croatia

Lithuania4 sites

  • LT302

    Kaunas

  • LT303

    Kaunas

  • LT301

    Vilnius

  • LT304

    Vilnius

Other trials in Lithuania

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

Portugal2 sites

  • PT301

    Amadora

  • PT302

    Coimbra

Other trials in Portugal

Ireland1 site

  • IE301

    Cork

Other trials in Ireland

About this study

Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil

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

Read the 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 10 mg/day or 30 mg/day as adjunctive therapy to donepezil 10 mg/day, and a 4-week safety follow-up period following study completion or withdrawal from treatment.

Being tested
Placebo, Idalopirdine
Medical subject headings
Alzheimer Disease

What participants receive

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

  • PlaceboDrug

    Once daily, matching placebo capsules, orally

  • IdalopirdineDrug

    Also called Lu AE58054

    Once daily, encapsulated tablets, orally

Study groups in NCT02006641
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo adjunct to 10 mg Donepezil
Receives: Drug: Placebo
Idalopirdine 10 mgExperimentalIdalopirdine adjunct to 10 mg Donepezil
Receives: Drug: Idalopirdine
Idalopirdine 30 mgExperimentalIdalopirdine adjunct to 10 mg Donepezil
Receives: Drug: Idalopirdine

What is being measured

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

  1. Change in Cognition

    Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.

    The Alzheimer's Disease Assessment Scale - Cognitive subscale (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 and Week 24

Secondary outcomes (10)

  1. Change in Daily Functioning

    Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.

    The Alzheimer's Disease Cooperative Study - Activities of Daily Living (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 and Week 24

  2. Change in Global Impression

    Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24.

    The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change 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: Baseline and Week 24

  3. Change in Behavioural Disturbance

    Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score.

    The Neuropsychiatric Inventory 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 and Week 24

  4. Change in Individual Behavioural Disturbance Items

    Change in single NPI item scores at Week 24.

    The Neuropsychiatric Inventory 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 then 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]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome.

    Measured: Baseline and Week 24

  5. Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline

    Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline

    The Neuropsychiatric Inventory 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 then 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 score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome.

    Measured: Baseline and Week 24

  6. Number of Participants With Clinical Improvement

    Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])

    Measured: Week 24

  7. Number of Participants With Clinical Worsening

    Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])

    Measured: Week 24

  8. Change in Cognitive Aspects of Mental Function

    Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (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 and Week 24

  9. Change in Health-related Quality of Life (EQ-5D) Utility Score

    Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score

    The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome.

    Measured: Baseline and Week 24

  10. Change in Health-related Quality of Life (EQ-5D VAS)

    Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS).

    The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Baseline and Week 24

Timeline

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

  1. First posted10 Dec 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
858 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02006641
Sponsor's protocol ID
14862A
Other IDs
2012-004764-22
Acronym
STARBEAM
Status last verified
Jan 2018
First submitted
5 Dec 2013
Last updated
20 Feb 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31193334

  • 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.

    PubMed 30474567

  • 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.

    PubMed 29318278

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Idalopirdine in people with Alzheimer's Disease, run by H. Lundbeck A/S at 162 sites in 19 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 7 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States, Argentina, Italy, Czechia, France and 14 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. Some participants in this study may receive a placebo. 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 20 Feb 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?

Change in Cognition (time frame: Baseline and Week 24). 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 NCT02006641, which also lists 3 linked publications.

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 20 Feb 2018.

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