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

Alzheimer's Disease Clinical Trial

— STARBRIGHT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006654
• Other study ID #: 14863A
• Secondary ID: 2012-004765-40
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2013
• Last updated: January 12, 2018
• Start date: March 2014
• Est. completion date: January 2017

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 acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 734
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• 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 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.

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 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.

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
Australia	AU603	Caulfield
Australia	AU609	Glen Iris
Australia	AU602	Heidelberg West
Australia	AU604	Kanwal
Australia	AU606	Newcastle
Australia	AU601	West Perth
Australia	AU610	Woodville south
Brazil	BR608	Belo Horizonte
Brazil	BR609	Itapira
Brazil	BR607	Rio de Janeiro
Czechia	CZ602	Chocen
Czechia	CZ608	Chocen
Czechia	CZ605	Havlickuv Brod
Czechia	CZ606	Kladno
Czechia	CZ603	Plzen
Czechia	CZ601	Prague
Czechia	CZ607	Praha 10 - Strasnice
Czechia	CZ604	Praha 6
Germany	DE612	Bad Homburg
Germany	DE610	Bad Honnef
Germany	DE609	Berlin
Germany	DE617	Berlin
Germany	DE604	Erbach
Germany	DE611	Freiburg
Germany	DE607	Gelsenkirchen
Germany	DE605	Homburg
Germany	DE608	Karlstadt
Germany	DE602	Mittweida
Germany	DE601	Munich
Germany	DE606	Rostock
Germany	DE603	Ulm
Germany	DE616	Unterhaching
Israel	IL605	Bat Yam
Israel	IL601	Haifa
Israel	IL604	Holon
Israel	IL602	Ramat Gan
Israel	IL603	Tel Aviv
Korea, Republic of	KR601	Seongnam-si
Korea, Republic of	KR602	Seoul
Korea, Republic of	KR603	Seoul
Korea, Republic of	KR604	Seoul
Mexico	MX602	Mexico
Mexico	MX601	Monterrey
Mexico	MX603	Monterrey
Mexico	MX604	Monterrey
Mexico	MX605	Monterrey
Mexico	MX606	Saltillo
Serbia	RS602	Belgrade
Serbia	RS603	Kragujevac
Serbia	RS601	Novi Sad
Singapore	SG601	Singapore
Singapore	SG602	Singapore
Slovakia	SK601	Banska Bystrica
Slovakia	SK603	Bratislava
Slovakia	SK605	Bratislava
Slovakia	SK604	Rimavska Sobota
Slovakia	SK602	Svidnik
Spain	ES601	Barcelona
Spain	ES603	Barcelona
Spain	ES604	Barcelona
Spain	ES608	Barcelona
Spain	ES611	Bilbao
Spain	ES612	Burgos
Spain	ES602	Lleida
Spain	ES613	Madrid
Spain	ES610	Sant Cugat del Vallès
Spain	ES606	Sevilla
Spain	ES605	Terrassa
Spain	ES607	Valencia
Switzerland	CH603	Biel
Switzerland	CH605	Lausanne
Switzerland	CH602	Les Acacias
Switzerland	CH601	Schlieren
Turkey	TR602	Balova
Turkey	TR601	Istanbul
Turkey	TR603	Istanbul
Turkey	TR605	Istanbul
Turkey	TR606	Izmir
Turkey	TR607	Samsun
United Kingdom	GB601	Brentford
United Kingdom	GB603	Northampton
United States	US621	Albany	New York
United States	US625	Bellflower	California
United States	US633	Charlotte	North Carolina
United States	US626	Costa Mesa	California
United States	US609	Danbury	Connecticut
United States	US608	Deerfield Beach	Florida
United States	US622	Elk Grove Village	Illinois
United States	US611	Elkhart	Indiana
United States	US601	Farmington Hills	Michigan
United States	US616	Hialeah	Florida
United States	US619	Houston	Texas
United States	US613	Lawrenceville	New Jersey
United States	US635	Manchester	New Jersey
United States	US612	Mesa	Arizona
United States	US620	Miami	Florida
United States	US618	Norristown	Pennsylvania
United States	US603	North Palm Beach	Florida
United States	US614	Norwalk	Connecticut
United States	US623	Oklahoma City	Oklahoma
United States	US604	Oxnard	California
United States	US631	Port Charlotte	Florida
United States	US606	Prairie Village	Kansas
United States	US607	Saint Louis	Missouri
United States	US627	Santa Ana	California
United States	US632	Staten Island	New York
United States	US630	Toms River	New Jersey

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Czechia,  Germany,  Israel,  Korea, Republic of,  Mexico,  Serbia,  Singapore,  Slovakia,  Spain,  Switzerland,  Turkey,  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 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 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 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).	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	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	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