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Pioglitazone Or Exercise to Treat Mild Cognitive Impairment (MCI) (POEM)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00736996
First received: August 14, 2008
Last updated: December 10, 2015
Last verified: December 2015
Results First Received: November 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Mild Cognitive Impairment
Interventions: Drug: Pioglitazone
Drug: Placebo
Behavioral: Endurance Exercise Training

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pioglitazone Pioglitazone: 45mg oral tablet daily for 6 months
Endurance Exercise Training Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
Placebo Placebo: Matching oral tablet daily for 6 months

Participant Flow:   Overall Study
    Pioglitazone     Endurance Exercise Training     Placebo  
STARTED     25     26     27  
COMPLETED     24     17     25  
NOT COMPLETED     1     9     2  
Lost to Follow-up                 1                 9                 2  



  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.
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Reporting Groups
  Description
Pioglitazone Pioglitazone: 45mg oral tablet daily for 6 months
Endurance Exercise Training Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
Placebo Placebo: Matching oral tablet daily for 6 months
Total Total of all reporting groups

Baseline Measures
    Pioglitazone     Endurance Exercise Training     Placebo     Total  
Number of Participants  
[units: participants]
  24     17     25     66  
Age  
[units: years]
Mean (Standard Deviation)
  65  (6)     64  (7)     68  (7)     65  (7)  
Gender  
[units: participants]
       
Female     13     7     15     35  
Male     11     10     10     31  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     4     0     0     4  
Not Hispanic or Latino     20     17     24     61  
Unknown or Not Reported     0     0     1     1  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     1     0     1     2  
Asian     0     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     3     1     1     5  
White     20     15     23     58  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     24     17     25     66  



  Outcome Measures
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1.  Primary:   Change in Cognitive Performance   [ Time Frame: Baseline to 6 months ]

2.  Secondary:   Change in Insulin Resistance   [ Time Frame: Baseline to 6 months ]

3.  Secondary:   Change in Peak Oxygen Uptake (VO2 Peak)   [ Time Frame: Baseline to 6 months ]


  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 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: Robert S. Schwartz, M.D.
Organization: University of Colorado
phone: 303-724-1919
e-mail: robert.schwartz@ucdenver.edu


Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00736996     History of Changes
Other Study ID Numbers: 07-1215
R01AG028746 ( US NIH Grant/Contract Award Number )
Study First Received: August 14, 2008
Results First Received: November 6, 2015
Last Updated: December 10, 2015
Health Authority: United States: Federal Government