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Trial record 1 of 1 for:    Effects of Simvastatin on CSF Alzheimer’s Disease Biomarkers in Cognitively Normal Subjects
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Effects of Simvastatin on Biomarkers (SimBio)

This study has been completed.
Sponsor:
Collaborators:
Seattle Institute for Biomedical and Clinical Research
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Gail Li, University of Washington
ClinicalTrials.gov Identifier:
NCT01142336
First received: June 9, 2010
Last updated: June 30, 2017
Last verified: June 2017
Results First Received: March 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Alzheimer's Disease
Interventions: Drug: Simvastatin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Statin-naïve middle-aged adults were recruited for this single-site trial (Seattle, WA) from the University of Washington Alzheimer's Disease Research Center Registry or the community through newsletters, websites, educational talks, health fairs, local clinics, and newspaper and magazine advertisements.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

917 people were pre-screened by phone for eligibility, 400 did not respond or declined, 457 did not meet inclusion/exclusion criteria.

60 completed a full screen visit. Of these 60 potential participants, 2 were lost to follow-up after screen, 2 withdrew, 7 screen failed and 49 were enrolled and randomized.


Reporting Groups
  Description
Simvastatin Simvastatin 40mg qHS for 1 year
Placebo Placebo 1 tablet qHS for 1 year

Participant Flow:   Overall Study
    Simvastatin   Placebo
STARTED   26   23 
COMPLETED   25   21 
NOT COMPLETED   1   2 
Adverse Event                1                1 
Lost to Follow-up                0                1 



  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
Placebo Placebo 1 tablet qHS for 1 year
Simvastatin Simvastatin 40mg qHS for 1 year
Total Total of all reporting groups

Baseline Measures
   Placebo   Simvastatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   26   49 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.1  (4.9)   55.7  (4.5)   55.9  (4.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  78.3%      19  73.1%      37  75.5% 
Male      5  21.7%      7  26.9%      12  24.5% 
Region of Enrollment 
[Units: Participants]
     
United States   23   26   49 
CSF Aβ42 level 
[Units: Pg/ml]
Mean (Standard Deviation)
 515  (113)   520  (114)   517  (113) 
CSF total tau level 
[Units: Pg/ml]
Mean (Standard Deviation)
 43  (17)   38  (16)   41  (16) 
CSF ptau level 
[Units: Pg/ml]
Mean (Standard Deviation)
 31  (15)   27  (10)   29  (12) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year   [ Time Frame: 1-year change of CSF Aβ42 from baseline ]

2.  Primary:   Change From Baseline in CSF Total Tau at 1 Year   [ Time Frame: 1-yr change ]

3.  Primary:   Change From Baseline in CSF ptau181 at 1 Year   [ Time Frame: 1-year change from baseline ]


  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
Sample size is small and statistical power is limited.


  More Information
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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: Ge Li, MD, PhD
Organization: University of Washington
phone: (206) 764-2485
e-mail: gli@uw.edu



Responsible Party: Gail Li, University of Washington
ClinicalTrials.gov Identifier: NCT01142336     History of Changes
Other Study ID Numbers: 37373
00183 ( Other Identifier: VA Puget Sound Health System MIRB# )
Study First Received: June 9, 2010
Results First Received: March 28, 2017
Last Updated: June 30, 2017