HealthyPhase 1NCT01456117
Study to Assess the Effects of Daily Administration of Pioglitazone on Brain Hemodynamics in Healthy Elderly Participants
A Phase 1 study testing Pioglitazone in people with Healthy, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of pioglitazone, once daily (QD), on brain hemodynamics in healthy elderly participants. Read more about this study
- Who is it for?
- Ages 55 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pioglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- The participant is a healthy adult male or female participant between the ages of 55 and 83 years, inclusive, at the time of informed consent and first dose of study medication dose.
- Female participants of childbearing potential will not be included in the study. Female participants must be post-menopausal (defined as >2 years without menses).
- The participant is considered to have normal cognitive abilities, as assessed by standard cognitive tests administered at the Screening visit. All participants will undergo a brief neuropsychological assessment which includes the Montreal Cognitive Assessment (MoCA) and Alzheimer Disease Cooperative Study Cognitive Function Screening Instrument to verify general cognitive status. Memory will be assessed with the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List Memory Test and Trail Making Part B. Normal performance will be defined as scores within 1 standard deviation (SD) of age and education normative mean.
Who cannot join
- The participant has received pioglitazone or any thiazolidinedione (TZD) in a previous clinical study or as a therapeutic agent within 1 year of Screening.
- The participant is an immediate family member, study site employee (defined as study personnel and employees directly supervised by study personnel), or in a dependant relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
- The participant has uncontrolled, clinically significant neurologic (e.g., migraines not well controlled, narcolepsy, previous head injury with loss of consciousness, or seizures), osteoporosis, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
- Participant has a known hypersensitivity or allergies to any component of the formulation of pioglitazone or related compounds.
- The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. Participant is unwilling to agree to abstain from alcohol 24 hours prior to MRI or unwilling to abstain from drugs throughout the study.
- History or evidence of any other central nervous system disorder that could be interpreted as a cause of dementia.
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- Current diagnosis of significant psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders Forth Edition Text Revision (DSM-IV-TR). Subjects with recent/past psychiatric disorders who are currently in remission/asymptomatic without the use of medication may be eligible as determined by the principal investigator and the medical monitor.
- Diabetes mellitus where the participant is being treated with insulin and/or peroxisome proliferator-activated receptor-ɣ (PPARɣ) agonist.
- Participant has a history of cancer that required chemotherapy treatment within the past 2 years prior to Day 1, metastatic cancer in the past 5 years prior to Day 1, or radiation treatment to the brain in their lifetime. Subjects with basal cell or stage I squamous cell carcinoma of the skin will be eligible. Eligibility of subjects with a history of cancer will be determined by the principal investigator and medical monitor.10. History of macular edema, degeneration or any maculopathy.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The purpose of this study is to assess the effects of pioglitazone, once daily (QD), on brain hemodynamics in healthy elderly participants.
Read the 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.
- Conditions
- Healthy
- Being tested
- Pioglitazone, Placebo
- Keywords
- Drug Therapy, pharmacodynamics, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called AD-4833, ACTOS
Pioglitazone once daily for up to 14 days.
PioglitazoneDrug
Also called AD-4833, ACTOS
Pioglitazone once daily for up to 14 days.
PioglitazoneDrug
Also called AD-4833, ACTOS
Pioglitazone once daily for up to 14 days.
PlaceboDrug
Pioglitazone matching placebo once daily for up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone (Dose 1) QD | Experimental | Not described Receives: Drug: Pioglitazone |
| Pioglitazone (Dose 2) QD | Experimental | Not described Receives: Drug: Pioglitazone |
| Pioglitazone (Dose 3) QD | Experimental | Not described Receives: Drug: Pioglitazone |
| Placebo QD | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in BOLD fMRI Signal Related to Pioglitazone in Regions of the Brain Related to Cognition.
Regions of the brain related to cognition include the hippocampus and the dorsolateral prefrontal cortex.
Measured: Baseline, Day 7 and Day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vice President Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456117
- Sponsor's protocol ID
- AD-4833/TOMM40_102
- Other IDs
- U1111-1125-0985
- Status last verified
- Aug 2012
- First submitted
- 18 Oct 2011
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01456117
- Acronym / sponsor ID
- AD-4833/TOMM40_102
- Conditions
- Healthy
- Keywords
- Drug Therapy, pharmacodynamics, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of pioglitazone, once daily (QD), on brain hemodynamics in healthy elderly participants.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone (Dose 1) QD | Experimental | Drug: Pioglitazone |
| Pioglitazone (Dose 2) QD | Experimental | Drug: Pioglitazone |
| Pioglitazone (Dose 3) QD | Experimental | Drug: Pioglitazone |
| Placebo QD | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- The participant is a healthy adult male or female participant between the ages of 55 and 83 years, inclusive, at the time of informed consent and first dose of study medication dose.
- Female participants of childbearing potential will not be included in the study. Female participants must be post-menopausal (defined as >2 years without menses).
- The participant is considered to have normal cognitive abilities, as assessed by standard cognitive tests administered at the Screening visit. All participants will undergo a brief neuropsychological assessment which includes the Montreal Cognitive Assessment (MoCA) and Alzheimer Disease Cooperative Study Cognitive Function Screening Instrument to verify general cognitive status. Memory will be assessed with the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List Memory Test and Trail Making Part B. Normal performance will be defined as scores within 1 standard deviation (SD) of age and education normative mean.
Key exclusion criteria (17 listed)
- The participant has received pioglitazone or any thiazolidinedione (TZD) in a previous clinical study or as a therapeutic agent within 1 year of Screening.
- The participant is an immediate family member, study site employee (defined as study personnel and employees directly supervised by study personnel), or in a dependant relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
- The participant has uncontrolled, clinically significant neurologic (e.g., migraines not well controlled, narcolepsy, previous head injury with loss of consciousness, or seizures), osteoporosis, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
- Participant has a known hypersensitivity or allergies to any component of the formulation of pioglitazone or related compounds.
- The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. Participant is unwilling to agree to abstain from alcohol 24 hours prior to MRI or unwilling to abstain from drugs throughout the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PioglitazoneAlso: AD-4833, ACTOSPioglitazone once daily for up to 14 days. | Drug | Pioglitazone (Dose 1) QD |
| PioglitazoneAlso: AD-4833, ACTOSPioglitazone once daily for up to 14 days. | Drug | Pioglitazone (Dose 2) QD |
| PioglitazoneAlso: AD-4833, ACTOSPioglitazone once daily for up to 14 days. | Drug | Pioglitazone (Dose 3) QD |
| PlaceboPioglitazone matching placebo once daily for up to 14 days. | Drug | Placebo QD |
Primary outcome
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.
Regions of the brain related to cognition include the hippocampus and the dorsolateral prefrontal cortex.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vice President Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pioglitazone in people with Healthy, run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2012.