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Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease (STAR Extension)

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ClinicalTrials.gov Identifier: NCT02079246
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Description
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Brief Summary:
To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Idalopirdine 60 mg Phase 3

Detailed Description:

This is an interventional, multi-national, multi-site, open-label extension study in patients with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or 14862A (NCT02006641).

Patients received 28-weeks of open-label treatment with idalopirdine 60 mg/day (option to reduce to 30 mg/day) as adjunctive treatment to donepezil. Approximately 100 patients, who had completed the initial 28-week period (OLEX), were included in a 24 week open-label treatment period with memantine (OLEX-MEM) that evaluated the safety and tolerability of concomitant memantine therapy in patients who were already on a stable treatment with idalopirdine and donepezil and for whom memantine treatment was clinically indicated.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1463 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
Actual Study Start Date : April 7, 2014
Actual Primary Completion Date : July 6, 2017
Actual Study Completion Date : July 6, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Donepezil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Idalopirdine (Lu AE58054) 60 mg
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
 Drug: Idalopirdine 60 mg
once daily, encapsulated tablets, orally
Experimental: Idalopirdine 60 mg + memantine
Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
 Drug: Idalopirdine 60 mg
once daily, encapsulated tablets, orally


Outcome Measures
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Primary Outcome Measures :
  1. Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX [ Time Frame: Baseline II (start of OLEX, week 0) to end of OLEX (week 28) ]
    A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.

  2. Number of TEAEs in the OLEX-MEM [ Time Frame: From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52) ]
    A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM).


Secondary Outcome Measures :
  1. Change in Cognition [ Time Frame: Baseline II (start of OLEX, Week 0) to Week 28 ]
    Change from Baseline II to Week 28 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score. The 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).

  2. Clinical Global Impression Score [ Time Frame: Week 28 ]
    Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 28. The ADCS-CGIC 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).

  3. Change in Daily Functioning [ Time Frame: Baseline II (start of OLEX, Week 0) to Week 28 ]
    Change from Baseline II to Week 28 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The 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).

  4. Change in Behavioural Disturbance [ Time Frame: Baseline II (start of OLEX, Week 0) to Week 28 ]
    Change from Baseline II to Week 28 in Neuropsychiatric Inventory (NPI) total score. The NPI 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).

  5. Change in Cognitive Aspects of Mental Function [ Time Frame: Baseline II (start of OLEX, Week 0) to Week 28 ]
    Change from Baseline II to Week 28 in Mini Mental State Examination (MMSE). The 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).

  6. Change in Cognitive Aspects of Mental Function [ Time Frame: Baseline III (start of OLEX-MEM, Week 28) to Week 52 ]
    Change from Baseline III to Week 52 in Mini Mental State Examination (MMSE). The 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).


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641

For patients in the OLEX-MEM:

  • The patient has completed Visit 6 (Week 28) of the OLEX.
  • The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/SmPC/treatment guidelines.

Exclusion Criteria:

  • The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator.
  • The patient has experienced seizures before Completion Visit in the lead-in study.
  • The patient has evidence of clinically significant disease.
  • The patient's donepezil treatment is likely to be interrupted or discontinued during the study.
  • The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).

Other protocol-defined inclusion and exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079246


Locations
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Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  Study Documents (Full-Text)

Documents provided by H. Lundbeck A/S:
Study Protocol  [PDF] June 16, 2015
Statistical Analysis Plan  [PDF] July 12, 2017

More Information
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02079246    
Other Study ID Numbers: 14861B
2013-000001-23 ( EudraCT Number )
First Posted: March 5, 2014    Key Record Dates
Results First Posted: August 10, 2018
Last Update Posted: August 10, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders