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

January 23, 2018 updated by: H. Lundbeck A/S

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

858

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Banfield, Argentina
        • AR303
      • Ciudad Autonoma Buenos Aires, Argentina
        • AR304
      • Ciudad Autonoma Buenos Aires, Argentina
        • AR308
      • Ciudad Autonoma Buenos Aires, Argentina
        • AR311
      • Ciudad Autonoma Buenos Aires, Argentina
        • AR313
      • Ciudad Autonoma Buenos Aires, Argentina
        • AR314
      • Ciudad Autonoma Buenos Aires, Argentina
        • AR301
      • Ciudad Autonoma Buenos Aires, Argentina
        • AR315
      • Ciudad Autonoma de Buenos Aires, Argentina
        • AR312
      • Cordoba, Argentina
        • AR309
      • Córdoba, Argentina
        • AR307
      • Godoy Cruz, Argentina
        • AR305
      • Mendoza, Argentina
        • AR310
      • Santa Fe, Argentina
        • AR302
      • Santiago del Estero, Argentina
        • AR306
  • Brazil
      • Curitiba, Brazil
        • BR307
      • Curitiba, Brazil
        • BR309
      • Rio de Janeiro, Brazil
        • BR301
      • Rio de Janeiro, Brazil
        • BR306
      • San Paolo, Brazil
        • BR308
  • Canada
      • Halifax, Canada
        • CA301
      • Kelowna, Canada
        • CA302
      • Montreal, Canada
        • CA306
      • Qubec, Canada
        • CA304
      • Sherbrooke, Canada
        • CA303
      • Toronto, Canada
        • CA305
  • Croatia
      • Zabok, Croatia
        • HR304
      • Zagreb, Croatia
        • HR301
      • Zagreb, Croatia
        • HR302
      • Zagreb, Croatia
        • HR303
  • Czechia
      • Brno, Czechia
        • CZ305
      • Chocen, Czechia
        • CZ309
      • Chocen, Czechia
        • CZ306
      • Pardubice, Czechia
        • CZ308
      • Praha 10, Czechia
        • CZ304
      • Praha 10 - Strasnice, Czechia
        • CZ310
      • Praha 2, Czechia
        • CZ307
      • Praha 6, Czechia
        • CZ301
      • Praha 6, Czechia
        • CZ303
      • Rychnov nad Kneznou, Czechia
        • CZ302
  • Estonia
      • Tallin, Estonia
        • EE303
      • Tallinn, Estonia
        • EE301
      • Tartu, Estonia
        • EE302
  • Finland
      • Kuopio, Finland
        • FI302
      • Oulu, Finland
        • FI303
      • Turku, Finland
        • FI301
  • France
      • Bordeaux, France
        • FR301
      • Bron, France
        • FR308
      • Colmar cedex, France
        • FR307
      • Dijon, France
        • FR304
      • Elancourt, France
        • FR309
      • Marseille cedex 5, France
        • FR302
      • Nice Cedex 1, France
        • FR303
      • Reims, France
        • FR306
      • Rouen, France
        • FR305
  • Hungary
      • Budapest, Hungary
        • HU304
      • Budapest, Hungary
        • HU305
      • Esztergom, Hungary
        • HU301
      • Gyor, Hungary
        • HU303
      • Szeged, Hungary
        • HU302
  • Ireland
      • Cork, Ireland
        • IE301
  • Israel
      • Haifa, Israel
        • IL302
      • Holon, Israel
        • IL303
      • Ramat Gan, Israel
        • IL304
  • Italy
      • Brescia, Italy
        • IT306
      • Brescia, Italy
        • IT309
      • Genova, Italy
        • IT311
      • Monza, Italy
        • IT312
      • Naples, Italy
        • IT302
      • Palermo, Italy
        • IT313
      • Perugia, Italy
        • IT307
      • Pisa, Italy
        • IT301
      • Roma, Italy
        • IT305
      • Roma, Italy
        • IT308
      • Torino, Italy
        • IT304
      • Torrette, Italy
        • IT310
  • Korea, Republic of
      • Busan, Korea, Republic of
        • KR303
      • Incheon, Korea, Republic of
        • KR301
      • Seongnam-si, Korea, Republic of
        • KR308
      • Seoul, Korea, Republic of
        • KR302
      • Seoul, Korea, Republic of
        • KR304
      • Seoul, Korea, Republic of
        • KR305
      • Seoul, Korea, Republic of
        • KR306
      • Seoul, Korea, Republic of
        • KR307
      • Seoul, Korea, Republic of
        • KR309
  • Lithuania
      • Kaunas, Lithuania
        • LT302
      • Kaunas, Lithuania
        • LT303
      • Vilnius, Lithuania
        • LT301
      • Vilnius, Lithuania
        • LT304
  • Poland
      • Bialystok, Poland
        • PL301
      • Bydgoszcz, Poland
        • PL304
      • Gdynia, Poland
        • PL308
      • Krakow, Poland
        • PL309
      • Lodz, Poland
        • PL302
      • Lubin, Poland
        • PL310
      • Lublin, Poland
        • PL306
      • Oswiecim, Poland
        • PL307
      • Poznan, Poland
        • PL303
  • Portugal
      • Amadora, Portugal
        • PT301
      • Coimbra, Portugal
        • PT302
  • Taiwan
      • Kaohsiung, Taiwan
        • TW301
      • Kaohsiung, Taiwan
        • TW302
      • Taichung, Taiwan
        • TW303
      • Taipei, Taiwan
        • TW304
      • Taipei, Taiwan
        • TW305
  • United Kingdom
      • Amersham, United Kingdom
        • GB307
      • Glasgow, United Kingdom
        • GB301
      • London, United Kingdom
        • GB303
      • London, United Kingdom
        • GB308
      • Plymouth, United Kingdom
        • GB306
      • Preston, United Kingdom
        • GB305
      • Southampton, United Kingdom
        • GB304
      • Swindon, United Kingdom
        • GB302
      • Warrington, United Kingdom
        • GB309
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • US338
    • Arkansas
      • Fayetteville, Arkansas, United States
        • US342
    • California
      • Anaheim, California, United States
        • US322
      • Carson, California, United States
        • US305
      • Costa Mesa, California, United States
        • US346
      • Fullerton, California, United States
        • US327
      • Lomita, California, United States
        • US315
      • Oceanside, California, United States
        • US351
      • Redlands, California, United States
        • US307
      • Santa Rosa, California, United States
        • US301
    • Connecticut
      • New London, Connecticut, United States
        • US337
      • Stamford, Connecticut, United States
        • US332
    • Florida
      • Delray Beach, Florida, United States
        • US308
      • Hallandale Beach, Florida, United States
        • US320
      • Hialeah, Florida, United States
        • US347
      • Lake Worth, Florida, United States
        • US340
      • Miami, Florida, United States
        • US303
      • Miami, Florida, United States
        • US313
      • Naples, Florida, United States
        • US335
      • Orange City, Florida, United States
        • US345
      • Palm Beach Gardens, Florida, United States
        • US309
      • Sunrise, Florida, United States
        • US302
    • Georgia
      • Atlanta, Georgia, United States
        • US304
      • Augusta, Georgia, United States
        • US360
      • Decatur, Georgia, United States
        • US318
    • Louisiana
      • Lake Charles, Louisiana, United States
        • US334
    • Massachusetts
      • Belmont, Massachusetts, United States
        • US350
      • Boston, Massachusetts, United States
        • US344
    • Minnesota
      • Saint Paul, Minnesota, United States
        • US310
    • Mississippi
      • Hattiesburg, Mississippi, United States
        • US321
    • Missouri
      • Creve Coeur, Missouri, United States
        • US330
    • New Jersey
      • Manchester, New Jersey, United States
        • US339
    • New York
      • Staten Island, New York, United States
        • US312
    • North Carolina
      • Charlotte, North Carolina, United States
        • US316
      • Winston-Salem, North Carolina, United States
        • US336
    • Ohio
      • Cincinnati, Ohio, United States
        • US323
      • Cleveland, Ohio, United States
        • US349
      • Columbus, Ohio, United States
        • US306
      • Lakewood, Ohio, United States
        • US352
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • US333
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • US314
      • Pittsburgh, Pennsylvania, United States
        • US324
      • Pittsburgh, Pennsylvania, United States
        • US341
      • Reading, Pennsylvania, United States
        • US325
    • South Carolina
      • Port Royal, South Carolina, United States
        • US319
    • Tennessee
      • Cordova, Tennessee, United States
        • US356
    • Texas
      • Fort Worth, Texas, United States
        • US343
      • Houston, Texas, United States
        • US354

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo adjunct to 10 mg Donepezil
Drug: Placebo
Once daily, matching placebo capsules, orally
Experimental: Idalopirdine 10 mg
Idalopirdine adjunct to 10 mg Donepezil
Drug: Idalopirdine
Once daily, encapsulated tablets, orally
Other Names:
  • Lu AE58054
Experimental: Idalopirdine 30 mg
Idalopirdine adjunct to 10 mg Donepezil
Drug: Idalopirdine
Once daily, encapsulated tablets, orally
Other Names:
  • Lu AE58054

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognition
Time Frame: Baseline and Week 24

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).
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Global Impression
Time Frame: Baseline and Week 24

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).
Baseline and Week 24
Change in Daily Functioning
Time Frame: Baseline and Week 24

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).
Baseline and Week 24
Change in Individual Behavioural Disturbance Items
Time Frame: Baseline and Week 24

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.
Baseline and Week 24
Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline
Time Frame: Baseline and Week 24

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.
Baseline and Week 24
Change in Health-related Quality of Life (EQ-5D) Utility Score
Time Frame: Baseline and Week 24

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.
Baseline and Week 24
Change in Health-related Quality of Life (EQ-5D VAS)
Time Frame: Baseline and Week 24

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).
Baseline and Week 24
Change in Behavioural Disturbance
Time Frame: Baseline and Week 24

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).
Baseline and Week 24
Number of Participants With Clinical Improvement
Time Frame: Week 24
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])
Week 24
Number of Participants With Clinical Worsening
Time Frame: Week 24
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])
Week 24
Change in Cognitive Aspects of Mental Function
Time Frame: Baseline and Week 24
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).
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14862A
  • 2012-004764-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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