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Alzheimer's DiseasePhase 3STARBRIGHTNCT02006654

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

A Phase 3 study testing Idalopirdine in people with Alzheimer's Disease, run by H. Lundbeck A/S at 107 sites in 15 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 acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
734 participants
Where
107 sitesin 15 countries
Study dates
Mar 2014to Jan 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 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.

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 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.
  • Other inclusion and exclusion criteria may apply.

Trial locations and contacts

107 sites in 15 countries.

107 sites in 15 countries

United States26 sites

  • US621

    Albany, New York

  • US625

    Bellflower, California

  • US633

    Charlotte, North Carolina

  • US626

    Costa Mesa, California

  • US609

    Danbury, Connecticut

  • US608

    Deerfield Beach, Florida

  • US622

    Elk Grove Village, Illinois

  • US611

    Elkhart, Indiana

  • US601

    Farmington Hills, Michigan

  • US616

    Hialeah, Florida

  • US619

    Houston, Texas

  • US613

    Lawrenceville, New Jersey

  • US612

    Mesa, Arizona

  • US620

    Miami, Florida

  • US618

    Norristown, Pennsylvania

  • US603

    North Palm Beach, Florida

  • US614

    Norwalk, Connecticut

  • US623

    Oklahoma City, Oklahoma

  • US604

    Oxnard, California

  • US635

    Paterson, New Jersey

  • US631

    Port Charlotte, Florida

  • US606

    Prairie Village, Kansas

  • US627

    Santa Ana, California

  • US607

    St Louis, Missouri

  • US632

    Staten Island, New York

  • US630

    Toms River, New Jersey

Other trials in United States

Germany14 sites

  • DE612

    Bad Homburg

  • DE610

    Bad Honnef

  • DE609

    Berlin

  • DE617

    Berlin

  • DE604

    Erbach im Odenwald

  • DE611

    Freiburg im Breisgau

  • DE607

    Gelsenkirchen

  • DE605

    Homburg

  • DE608

    Karlstadt am Main

  • DE602

    Mittweida

  • DE601

    Munich

  • DE606

    Rostock

  • DE603

    Ulm

  • DE616

    Unterhaching

Other trials in Germany

Spain12 sites

  • ES601

    Barcelona

  • ES603

    Barcelona

  • ES604

    Barcelona

  • ES608

    Barcelona

  • ES611

    Bilbao

  • ES612

    Burgos

  • ES602

    Lleida

  • ES613

    Madrid

  • ES610

    Sant Cugat del Vallès

  • ES606

    Seville

  • ES605

    Terrassa

  • ES607

    Valencia

Other trials in Spain

Czechia8 sites

  • CZ602

    Choceň

  • CZ608

    Choceň

  • CZ605

    Havlíčkův Brod

  • CZ606

    Kladno

  • CZ603

    Pilsen

  • CZ601

    Prague

  • CZ604

    Prague

  • CZ607

    Praha 10 - Strasnice

Other trials in Czechia

Australia7 sites

  • AU603

    Caulfield

  • AU609

    Glen Iris

  • AU602

    Heidelberg West

  • AU604

    Kanwal

  • AU606

    Newcastle

  • AU601

    West Perth

  • AU610

    Woodville South

Other trials in Australia

Mexico6 sites

  • MX602

    México

  • MX601

    Monterrey

  • MX603

    Monterrey

  • MX604

    Monterrey

  • MX605

    Monterrey

  • MX606

    Saltillo

Other trials in Mexico

Turkey (Türkiye)6 sites

  • TR602

    Balova

  • TR601

    Istanbul

  • TR603

    Istanbul

  • TR605

    Istanbul

  • TR606

    Izmir

  • TR607

    Samsun

Other trials in Turkey (Türkiye)

Israel5 sites

  • IL605

    Bat Yam

  • IL601

    Haifa

  • IL604

    Holon

  • IL602

    Ramat Gan

  • IL603

    Tel Aviv

Other trials in Israel

Slovakia5 sites

  • SK601

    Banská Bystrica

  • SK603

    Bratislava

  • SK605

    Bratislava

  • SK604

    Rimavská Sobota

  • SK602

    Svidník

Other trials in Slovakia

South Korea4 sites

  • KR601

    Seongnam-si

  • KR602

    Seoul

  • KR603

    Seoul

  • KR604

    Seoul

Other trials in South Korea

Switzerland4 sites

  • CH603

    Biel

  • CH605

    Lausanne

  • CH602

    Les Acacias

  • CH601

    Schlieren

Other trials in Switzerland

Brazil3 sites

  • BR608

    Belo Horizonte

  • BR609

    Itapira

  • BR607

    Rio de Janeiro

Other trials in Brazil

Serbia3 sites

  • RS602

    Belgrade

  • RS603

    Kragujevac

  • RS601

    Novi Sad

Other trials in Serbia

Singapore2 sites

  • SG601

    Singapore

  • SG602

    Singapore

Other trials in Singapore

United Kingdom2 sites

  • GB601

    Brentford

  • GB603

    Northampton

Other trials in United Kingdom

About this study

Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-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 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).

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 NCT02006654
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo adjunct to base treatment with an AChEI
Receives: Drug: Placebo
Idalopirdine 60 mg (or 30 mg)ExperimentalIdalopirdine adjunct to base treatment with an AChEI
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 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

  2. 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

  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 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 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. 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. 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 startMar 2014
  3. Primary completionJan 2017
  4. Study completionJan 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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
734 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02006654
Sponsor's protocol ID
14863A
Other IDs
2012-004765-40
Acronym
STARBRIGHT
Status last verified
Jan 2018
First submitted
5 Dec 2013
Last updated
7 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 107 sites in 15 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 7 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 107 sites in United States, Germany, Spain, Czechia, Australia and 10 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 7 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 NCT02006654, 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 7 Feb 2018.

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