Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01931566) enrolled 3,494 participants across three groups: a "low risk" placebo group (433 people), a "high risk" placebo group (1,516 people), and a "high risk" pioglitazone (a diabetes medication being studied here) group (1,545 people). The trial was measuring how long it took for people — particularly those identified as being at higher genetic risk — to be diagnosed with mild cognitive impairment thought to be caused by Alzheimer's disease (a stage where memory and thinking show early decline). It also looked at changes in thinking and memory test scores and in participants' ability to carry out everyday tasks. The reported data shows that, for the primary outcome, the average time before a diagnosis of mild cognitive impairment was recorded was approximately 905 days in the low-risk placebo group and approximately 1,239 days in the high-risk placebo group. When comparing the two high-risk groups, the reported figure was approximately 1,239 days for those on placebo and approximately 1,261 days for those taking pioglitazone. For the secondary outcomes, the reported change in the combined thinking and memory test score was 0.18 for the high-risk placebo group and 0.17 for the high-risk pioglitazone group (on a scale where higher numbers indicate better cognition). For the everyday tasks measure, the reported change was 0.1 for the placebo group and 0.3 for the pioglitazone group (on a scale of 0–45, where lower scores indicate greater difficulty). It is worth noting that the number of participants recorded as completing the study was very small — only 4, 40, and 39 across the three groups respectively — and the data for some measures was not broken down further in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 37874111) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Alzheimer's Disease Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- The study doctor believes you can understand and follow the study requirements
- You have signed a written consent form before any study activities begin
- You are physically able to complete memory and thinking tests, and you speak the language in which the tests are given
- Your memory and thinking are considered normal at the start of the study, based on specific test scores
- You score 25 or higher on a standard memory screening test (adjusted for your age and education level)
- You are a man or a woman who has gone through menopause, and you are between 65 and 83 years old at the time of screening
- The study doctor believes you are able and willing to attend regular study visits
- You have a "study partner" (such as a family member or close friend) who is willing to provide information about your memory and daily functioning, and help track your study medication if needed
Who may not be able to join:
- You have been diagnosed with, or have a history of, any form of memory loss, dementia, or any brain or mental health condition that significantly affects thinking
- You currently have a significant mental health condition (such as major depression or anxiety) that is in an active phase, or you have a history of schizophrenia or bipolar disorder
- Your blood sugar control is poor (HbA1c above 8%), or you take insulin, three or more diabetes medicines, or a specific type of diabetes drug called a PPAR-γ agonist (confirm with trial site)
- You have a serious ongoing health condition affecting the liver, kidneys, heart, lungs, or other major body systems, or you have a history of HIV infection
- You have a history of drug misuse or alcohol dependence within the past 2 years
- You are an immediate family member of, or in a dependent relationship with, someone working on this study, or you may feel pressured to join
- You have had an allergic reaction to pioglitazone or similar medications
- You are required to take any medications that are not allowed in this study
- Certain blood test results at your baseline visit are outside acceptable ranges, including liver-related values or unexplained blood in the urine
- You test positive for Hepatitis B or Hepatitis C at your baseline visit
- You have a health condition or take a medication that the study doctor believes could interfere with the study or your ability to participate safely
- You have taken part in another clinical study or received an experimental treatment within the past 30 days (or within a specific timeframe before screening)
- You have had cancer that has been in remission for less than 2 years — though some early-stage skin cancers may still be eligible; a history of bladder cancer disqualifies you regardless of remission status
- You have a history of or currently have macular edema or macular degeneration (certain eye conditions)
- If you are a woman, you have a history of broken bones after menopause from little or no physical force (such as a wrist, hip, or spine fracture)
- You have been diagnosed with moderate to severe heart failure
- You have completed the specific memory and thinking tests used in this study within the past 6 months (except for the basic MMSE screening test)
- You already know, or the study staff know, your results for certain genetic tests related to Alzheimer's risk (TOMM40 or APOE) (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Medical Director, Takeda
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to Diagnosis of Mild Cognitive Impairment Due to Alzheimer's Disease (MCI-AD) for Placebo-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, Low-risk, Non-Hispanic/Latino Caucasian Participants; Time to Diagnosis of MCI Due to AD for Pioglitazone-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, High-risk, Non-Hispanic/Latino, Caucasian Participants
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.