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Alzheimer's DiseasePhase 3STARSHINENCT01955161

Study of 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 137 sites in 16 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
933 participants
Where
137 sitesin 16 countries
Study dates
Oct 2013to Jul 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

137 sites in 16 countries.

137 sites in 16 countries

United States46 sites

  • US049

    Albany, New York

  • US010

    Amherst, New York

  • US047

    Arlington, Virginia

  • US020

    Atlanta, Georgia

  • US027

    Birmingham, Alabama

  • US042

    Boca Raton, Florida

  • US021

    Bradenton, Florida

  • US050

    Brooksville, Florida

  • US007

    Centerville, Ohio

  • US030

    Chicago, Illinois

  • US006

    Columbus, Ohio

  • US060

    Denver, Colorado

  • US052

    Edmond, Oklahoma

  • US041

    Flowood, Mississippi

  • US036

    Freeport, Maine

  • US053

    Glendale, California

  • US023

    Imperial, California

  • US040

    Indianapolis, Indiana

  • US057

    Jenkintown, Pennsylvania

  • US051

    Joliet, Illinois

  • US048

    Kailua, Hawaii

  • US035

    Kalamazoo, Michigan

  • US015

    La Jolla, California

  • US024

    Little Rock, Arkansas

  • US045

    Long Beach, California

  • US002

    Los Angeles, California

  • US025

    Madison, Wisconsin

  • US014

    Manhasset, New York

  • US004

    Milwaukee, Wisconsin

  • US008

    New York, New York

  • US029

    New York, New York

  • US056

    New York, New York

  • US032

    Newton, Massachusetts

  • US037

    Orangeburg, New York

  • US019

    Orlando, Florida

  • US012

    Phoenix, Arizona

  • US038

    Port Charlotte, Florida

  • US026

    Portland, Oregon

  • US046

    Princeton, New Jersey

  • US058

    San Francisco, California

  • US018

    Santa Ana, California

  • US054

    St Louis, Missouri

  • US043

    Staten Island, New York

  • US028

    Toms River, New Jersey

  • US044

    Toms River, New Jersey

  • US001

    West Palm Beach, Florida

Other trials in United States

Argentina9 sites

  • AR002

    Buenos Aires

  • AR003

    Buenos Aires

  • AR006

    Buenos Aires

  • AR007

    Buenos Aires

  • AR009

    Córdoba

  • AR004

    Mar del Plata

  • AR005

    Mendoza

  • AR008

    Mendoza

  • AR010

    Rosario

Other trials in Argentina

Germany8 sites

  • DE002

    Berlin

  • DE006

    Ellwangen

  • DE010

    Günzburg

  • DE005

    Hanover

  • DE007

    Heidelberg

  • DE009

    München

  • DE008

    Ulm

  • DE004

    Unterhaching

Other trials in Germany

Bulgaria7 sites

  • BG005

    Plovdiv

  • BG001

    Sofia

  • BG002

    Sofia

  • BG003

    Sofia

  • BG004

    Sofia

  • BG006

    Sofia

  • BG007

    Varna

Other trials in Bulgaria

Czechia7 sites

  • CZ006

    Brno

  • CZ007

    Kutná Hora

  • CZ004

    Pardubice

  • CZ001

    Prague

  • CZ002

    Prague

  • CZ003

    Prague

  • CZ005

    Rychnov nad Kněžnou

Other trials in Czechia

France7 sites

  • FR006

    Besançon

  • FR008

    Limoges Cedex1

  • FR003

    Nantes

  • FR001

    Paris

  • FR005

    Paris

  • FR004

    Saint-Etienne

  • FR002

    Toulouse

Other trials in France

Italy7 sites

  • IT004

    Ancona

  • IT006

    Brescia

  • IT002

    Florence

  • IT005

    Genoa

  • IT003

    Lamezia Terme

  • IT001

    Milan

  • IT007

    Palermo

Other trials in Italy

Poland7 sites

  • PL004

    Gliwice

  • PL007

    Katowice

  • PL005

    Poznan

  • PL006

    Sopot

  • PL002

    Szczecin

  • PL003

    Warsaw

  • PL008

    Wroclaw

Other trials in Poland

South Africa7 sites

  • ZA003

    Bloemfontein

  • ZA006

    Cape Town

  • ZA007

    Cape Town

  • ZA004

    George

  • ZA005

    Port Elizabeth

  • ZA001

    Pretoria

  • ZA002

    Rosebank

Other trials in South Africa

Belgium6 sites

  • BE003

    Bruges

  • BE002

    Brussels

  • BE004

    Brussels

  • BE005

    Leuven

  • BE001

    Roeselare

  • BE006

    Thuin

Other trials in Belgium

Spain6 sites

  • ES002

    Alicante

  • ES006

    Barcelona

  • ES001

    Donostia / San Sebastian

  • ES005

    Manresa

  • ES004

    Salamanca

  • ES003

    Santiago de Compostela

Other trials in Spain

Canada5 sites

  • CA002

    Gatineau

  • CA006

    London

  • CA008

    Newmarket

  • CA001

    Toronto

  • CA004

    Toronto

Other trials in Canada

Chile5 sites

  • CL004

    Antofagasta

  • CL002

    Santiago

  • CL003

    Santiago

  • CL005

    Santiago

  • CL001

    Valdivia

Other trials in Chile

Ukraine5 sites

  • UA008

    Dnipropetrovsk

  • UA006

    Kherson,Vil. Stepanivka

  • UA005

    Kyiv

  • UA007

    Kyiv

  • UA001

    Lviv

Other trials in Ukraine

Denmark3 sites

  • DK003

    Aarhus N

  • DK001

    Copenhagen

  • DK002

    Odense C

Other trials in Denmark

Romania2 sites

  • RO002

    Bucharest

  • RO001

    Târgu Mureş

Other trials in Romania

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 30 mg/day or 60 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

    Once daily, encapsulated tablets, orally

Study groups in NCT01955161
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo adjunct to 10 mg Donepezil
Receives: Drug: Placebo
Idalopirdine 30 mgExperimentalIdalopirdine adjunct to 10 mg Donepezil
Receives: Drug: Idalopirdine
Idalopirdine 60 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 posted7 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJul 2016
  4. Study completionJul 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
933 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01955161
Sponsor's protocol ID
14861A
Other IDs
2012-004763-45
Acronym
STARSHINE
Status last verified
Aug 2017
First submitted
27 Sep 2013
Last updated
19 Sep 2017
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 137 sites in 16 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States, Argentina, Germany, Bulgaria, Czechia and 11 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 19 Sep 2017). 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 to 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 NCT01955161, 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 19 Sep 2017.

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