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

Alzheimer's Disease Clinical Trial

— STARBEAM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006641
• Other study ID #: 14862A
• Secondary ID: 2012-004764-22
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2013
• Last updated: January 23, 2018
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 858
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Placebo
Once daily, matching placebo capsules, orally
• Idalopirdine
Once daily, encapsulated tablets, orally

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	Otsuka Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Croatia,  Czechia,  Estonia,  Finland,  France,  Hungary,  Ireland,  Israel,  Italy,  Korea, Republic of,  Lithuania,  Poland,  Portugal,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and Week 24
Secondary	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).	Baseline and Week 24
Secondary	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).	Baseline and Week 24
Secondary	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).	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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])	Week 24
Secondary	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])	Week 24
Secondary	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).	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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).	Baseline and Week 24