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 enrolled 331 people, all of whom received a once-daily extended-release tablet of rosiglitazone (RSG XR) at 8 mg. Only 26 participants completed the study, while 305 did not finish. The trial was designed to track and record any unwanted medical events (called adverse events) that participants experienced while taking the medication, as well as changes in their blood pressure and heart rate over time. The reported data shows that out of 331 participants, 125 experienced at least one adverse event of special interest — meaning a medical occurrence that researchers had pre-identified as worth watching closely based on the nature of the drug. Of those, 46 were described as mild, 31 as moderate, and 13 as severe, with 2 recorded at the highest severity level. Eight participants experienced a serious adverse event (a medical event serious enough to require hospitalisation or be life-threatening, for example), and 3 deaths were recorded during or after the study period. Thirteen per cent of participants were reported to have experienced fluid retention or swelling (oedema). The reported data shows small average changes in blood pressure across different time points — generally in the range of a few millimetres of mercury up or down — and similarly small average changes in heart rate of roughly 1 to 3 beats per minute across different visits. These numbers are the averages across the group; individual experiences are not detailed in the submitted data. 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 20733306) ↗
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
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- You must have completed a previous related study (called AVA105640) without serious safety or tolerability problems, and both you and your doctor agree that the study drug (RSG XR) could be beneficial for you.
- If you are a woman who could become pregnant, you must agree to use an effective form of birth control for the whole study, and you must have a negative pregnancy test (urine test) within 7 days before your first visit.
- You must be willing to take part in this extension study and sign a written consent form before any study procedures begin; if you are unable to sign due to your cognitive condition, a legally authorised representative may sign on your behalf (where local rules allow this).
- You must live with, or have regular and substantial contact with, a caregiver who is willing to attend all study visits, help make sure you take your medication correctly, and report on how you are doing.
- You must be able to take part in memory and other thinking-related tests during the study.
- Your caregiver must also sign their own written consent form before any study procedures begin.
- Your heart rhythm measurement (called QTc) must be below a certain level at your first visit — below 450 milliseconds, or below 480 milliseconds if you have a specific heart conduction condition called bundle branch block (confirm with trial site).
- If you are in France, you must be affiliated with or covered by a social security scheme.
- If you are a woman on hormone replacement therapy (HRT) and it is unclear whether you have gone through menopause, you may need to use highly effective contraception during the study, or temporarily stop HRT to confirm your menopausal status before joining.
- If your caregiver does not live with you, they must typically spend at least 10 hours per week with you, spread across several days, so they can reliably report on your health and wellbeing (confirm with trial site).
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You had a serious bad reaction or a significant abnormal lab result during the previous study (AVA105640) that may have been caused by the study drug, and this problem is still ongoing.
- Your doctor feels you are not suitable for the study for any reason, including health concerns, difficulty following study rules, or caregiver availability.
- You had a significant heart event during the previous study (such as a heart attack, unstable chest pain, or serious irregular heartbeat), unless a full heart evaluation has confirmed you do not have heart failure and your condition is stable.
- You have heart failure (as defined by standard medical guidelines) at the time of your first visit.
- You have noticeable swelling in your limbs (such as swollen ankles or legs) at the time of your first visit.
- Your liver-related blood test results are significantly above the normal range, or you have a history of serious liver disease (such as hepatitis B or C, or cirrhosis).
- You are a close family member or employee of the doctor running the study, any staff at the study site, or the company sponsoring the study (GSK).
- If you are in France, you are not affiliated with or covered by a social security scheme.
- If you are in France, you have taken part in another study using an experimental drug within the past 30 days (other than the previous related study, AVA105640).
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Number of Participants With Any Adverse Events (AEs) and Severity of AEs
Other options
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.