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

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ClinicalTrials.gov Identifier: NCT02006641
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Placebo
Drug: Idalopirdine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

Placebo adjunct to 10 mg Donepezil

Placebo: Once daily, matching placebo capsules, orally

Idalopirdine 10 mg

Idalopirdine adjunct to 10 mg Donepezil

Idalopirdine: Once daily, encapsulated tablets, orally

Idalopirdine 30 mg

Idalopirdine adjunct to 10 mg Donepezil

Idalopirdine: Once daily, encapsulated tablets, orally


Participant Flow:   Overall Study
    Placebo   Idalopirdine 10 mg   Idalopirdine 30 mg
STARTED   284   290   284 
Treated   282   285   281 
COMPLETED   258   257   248 
NOT COMPLETED   26   33   36 
Withdrawal before treatment                2                5                3 
Adverse Event                15                11                15 
Protocol Violation                0                2                2 
Lost to Follow-up                0                1                0 
Withdrawal by Subject                7                12                11 
Other reason: patient didn't show up                1                0                0 
Other reason:patient didn't want to come                0                0                1 
Other reason: patient has moved                1                0                1 
Other reason: caregiver in hospital                0                1                0 
Other reason: patient's wife has died                0                0                1 
Other reason: hospitalisation                0                1                0 
Other reason: caregiver impossibility                0                0                1 
Other reason: protocol non-compliance                0                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 858 patients were randomized into the study but 10 patients were not treated (did not receive IMP). The baseline analysis population only consist of patients who have been treated.

Reporting Groups
  Description
Placebo

Placebo adjunct to 10 mg Donepezil

Placebo: Once daily, matching placebo capsules, orally

Idalopirdine 10 mg

Idalopirdine adjunct to 10 mg Donepezil

Idalopirdine: Once daily, encapsulated tablets, orally

Idalopirdine 30 mg

Idalopirdine adjunct to 10 mg Donepezil

Idalopirdine: Once daily, encapsulated tablets, orally

Total Total of all reporting groups

Baseline Measures
   Placebo   Idalopirdine 10 mg   Idalopirdine 30 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 282   285   281   848 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.4  (8.3)   74.9  (8.1)   75.0  (8.0)   74.4  (8.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      181  64.2%      172  60.4%      169  60.1%      522  61.6% 
Male      101  35.8%      113  39.6%      112  39.9%      326  38.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      10   3.5%      11   3.9%      10   3.6%      31   3.7% 
Not Hispanic or Latino      42  14.9%      47  16.5%      41  14.6%      130  15.3% 
Unknown or Not Reported      230  81.6%      227  79.6%      230  81.9%      687  81.0% 
Race (NIH/OMB) [1] [2] 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native   NA [1]   NA [1]   NA [1]   NA [2] 
Asian      20   7.1%      24   8.4%      24   8.5%      68   8.0% 
Native Hawaiian or Other Pacific Islander   NA [1]   NA [1]   NA [1]   NA [2] 
Black or African American      6   2.1%      6   2.1%      4   1.4%      16   1.9% 
White      250  88.7%      249  87.4%      244  86.8%      743  87.6% 
More than one race   NA [1]   NA [1]   NA [1]   NA [2] 
Unknown or Not Reported      6   2.1%      6   2.1%      9   3.2%      21   2.5% 
[1] Information has not been collected
[2] Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Argentina   23   26   24   73 
Hungary   7   4   4   15 
Czechia   16   15   17   48 
United States   54   58   52   164 
United Kingdom   29   28   25   82 
Portugal   4   6   5   15 
Canada   11   9   10   30 
South Korea   14   16   16   46 
Finland   4   5   4   13 
Taiwan   6   5   6   17 
Brazil   13   13   11   37 
Poland   31   26   30   87 
Italy   21   22   22   65 
Israel   3   3   3   9 
France   12   12   12   36 
Lithuania   13   16   16   45 
Estonia   15   17   18   50 
Croatia   6   4   6   16 
MMSE total score at screening [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 17.6  (2.9)   17.4  (3.0)   17.5  (3.0)   17.5  (3.0) 
[1] 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).


  Outcome Measures

1.  Primary:   Change in Cognition   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Change in Daily Functioning   [ Time Frame: Baseline and Week 24 ]

3.  Secondary:   Change in Global Impression   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:   Change in Behavioural Disturbance   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   Change in Individual Behavioural Disturbance Items   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:   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 ]

7.  Secondary:   Number of Participants With Clinical Improvement   [ Time Frame: Week 24 ]

8.  Secondary:   Number of Participants With Clinical Worsening   [ Time Frame: Week 24 ]

9.  Secondary:   Change in Cognitive Aspects of Mental Function   [ Time Frame: Baseline and Week 24 ]

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Email contact via
Organization: H. Lundbeck A/S
phone: +4536301311
e-mail: LundbeckClinicalTrials@lundbeck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02006641     History of Changes
Other Study ID Numbers: 14862A
2012-004764-22 ( EudraCT Number )
First Submitted: December 5, 2013
First Posted: December 10, 2013
Results First Submitted: December 19, 2017
Results First Posted: February 20, 2018
Last Update Posted: February 20, 2018