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A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01548287
First received: March 5, 2012
Last updated: October 12, 2016
Last verified: October 2016
Results First Received: January 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Mild Cognitive Impairment
Mild Alzheimer's Disease
Interventions: Drug: AZD5213
Other: Placebo

  Participant Flow
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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
164 subjects signed informed consent and 83 failed to qualify at the first screening visit for participation in the study.

Reporting Groups
  Description
AZD5213 Dose A AZD5213 AZD 0.5 mg daily
AZD5213 Dose B AZD 5213 2.0 mg daily
AZD5213 Dose C AZD5213 6.0 mg daily
Placebo Placebo daily
Screening Only Screening period only, not randomized

Participant Flow for 2 periods

Period 1:   Screening
    AZD5213 Dose A   AZD5213 Dose B   AZD5213 Dose C   Placebo   Screening Only
STARTED   19   22   20   20   83 
COMPLETED   19   22   20   20   0 
NOT COMPLETED   0   0   0   0   83 
No reason provided                0                0                0                0                9 
Did not meet eligibility criteria                0                0                0                0                74 

Period 2:   Randomized Period
    AZD5213 Dose A   AZD5213 Dose B   AZD5213 Dose C   Placebo   Screening Only
STARTED   19   22   20   20   0 
COMPLETED   19   20   13   20   0 
NOT COMPLETED   0   2   7   0   0 
Did not meet inclusion criteria                0                0                2                0                0 
Adverse Event                0                2                5                0                0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
AZD5213 Dose A AZD5213 AZD 0.5 mg daily
AZD5213 Dose B AZD 5213 2.0 mg daily
AZD5213 Dose C AZD5213 6.0 mg daily
Placebo Placebo daily
Total Total of all reporting groups

Baseline Measures
   AZD5213 Dose A   AZD5213 Dose B   AZD5213 Dose C   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   22   20   20   81 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.1  (8.02)   65.1  (8.04)   69.3  (10.32)   64.2  (7.62)   66.1  (8.62) 
Gender 
[Units: Participants]
         
Female   12   16   13   15   56 
Male   7   6   7   5   25 
Mini-Mental State Examination [1] 
[Units: Scores on scale]
Mean (Standard Deviation)
 27.2  (1.38)   27.0  (2.01)   26.1  (1.62)   27.0  (1.88)   26.8  (1.77) 
[1] Mini-Mental Scale Examination, Total Score range 0-30, higher score indicates less cognitive impairment
Alzheimers disease (AD)/Mild cognitive impairment (MCI) 
[Units: Participants]
         
AD   3   6   5   5   19 
MCI   16   16   15   15   62 
Concomitant donepezil administration 
[Units: Participants]
         
Yes   2   1   3   3   9 
No   17   21   17   17   72 


  Outcome Measures
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1.  Primary:   Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.   [ Time Frame: Baseline and Week 4. ]

2.  Secondary:   Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.   [ Time Frame: Baseline and Week 4. ]

3.  Secondary:   Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.   [ Time Frame: Baseline and Week 4. ]

4.  Secondary:   Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.   [ Time Frame: Baseline and Week 4. ]

5.  Secondary:   Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.   [ Time Frame: Baseline and Week 4. ]

6.  Secondary:   Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.   [ Time Frame: Baseline and Week 4. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joel Posener, MD
Organization: AstraZeneca Pharmaceuticals LP, Neuroscience iMed
e-mail: clinicaltrialtransparency@astrazeneca.net



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01548287     History of Changes
Other Study ID Numbers: D3030C00005
Study First Received: March 5, 2012
Results First Received: January 26, 2015
Last Updated: October 12, 2016
Health Authority: United States: Food and Drug Administration