Study to Assess the Effects of Daily Administration of Pioglitazone on Brain Hemodynamics in Healthy Elderly Participants
Tracking Information | |||||
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First Received Date ICMJE | October 18, 2011 | ||||
Last Updated Date | August 6, 2012 | ||||
Start Date ICMJE | November 2011 | ||||
Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change from Baseline in BOLD fMRI Signal Related to Pioglitazone in Regions of the Brain Related to Cognition. [ Time Frame: Baseline, Day 7 and Day 14. ] [ Designated as safety issue: No ] Regions of the brain related to cognition include the hippocampus and the dorsolateral prefrontal cortex. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01456117 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Assess the Effects of Daily Administration of Pioglitazone on Brain Hemodynamics in Healthy Elderly Participants | ||||
Official Title ICMJE | A Phase 1, Multiple-Dose, Single-Blind Parallel Design, Single-Center, Dose-Ranging Study to Assess the Effects of Daily Administration of Pioglitazone for 14 Days on the Brain Hemodynamics of Healthy Elderly Subjects | ||||
Brief Summary | The purpose of this study is to assess the effects of pioglitazone, once daily (QD), on brain hemodynamics in healthy elderly participants. |
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Detailed Description | The study will evaluate the effects on resting-state networks before and after therapeutic intervention, and also on task-related brain networks after specific cognitive challenges. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
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Condition ICMJE | Healthy | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 61 | ||||
Completion Date | July 2012 | ||||
Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
11. Participant with a glycosylated hemoglobin (HbA1c) ≥6%. 12. Participant with congestive heart failure or significant edema (2+) of the extremities. 13. History of postmenopausal bone fracture (females only). 14. If male, the participant intends to donate sperm during the course of this study or for 30 days after the last dose of study drug. 15. Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]). 16. Participant has a positive test result for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (anti-HCV) at Screening or a known history of human immunodeficiency virus infection (HIV). 17. Participant has a Screening or Check-in (Day 1) abnormal (clinically significant) ECG. (Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by principal investigator. (If principal investigator is not a MD, ECG must be assessed by a qualified investigator). 18. Participant has abnormal Screening or Day 1 laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) >2x the upper limits of normal (ULN). 19. Participant has a contraindication to having MRI, for example because of ferromagnetic foreign bodies (e.g., unremovable ferromagnetic dental work), medical devices such as aneurysm clips or cardiac pacemakers, or lead-based tattoos. 20. Participant has hematuria (microscopic or macroscopic) at Screening. |
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Gender | Both | ||||
Ages | 55 Years to 83 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01456117 | ||||
Other Study ID Numbers ICMJE | AD-4833/TOMM40_102, U1111-1125-0985 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Takeda Global Research & Development Center, Inc. | ||||
Study Sponsor ICMJE | Takeda Global Research & Development Center, Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Takeda Global Research & Development Center, Inc. | ||||
Verification Date | August 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |