Brain Imaging Study Of Rosiglitazone Efficacy And Safety In Alzheimer's Disease
NCT00265148, Phase 2, Completed, GlaxoSmithKline; results first posted 2020-11-18
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Brain Imaging Study Of Rosiglitazone Efficacy And Safety In Alzheimer's Disease | ClinicalTrials.gov |
| NCT number | NCT00265148 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 80 participants, actual | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Conditions | Alzheimer's Disease | ClinicalTrials.gov |
| Interventions | Rosiglitazone, Placebo | ClinicalTrials.gov |
| First posted | 2005-12-14 | ClinicalTrials.gov |
| Last updated | 2020-11-18 | ClinicalTrials.gov |
| Other registries' IDs | eudract:2005-005089-34 | ClinicalTrials.gov |
| Results first posted | 2020-11-18 | ClinicalTrials.gov |
Registered outcomes 27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Baseline (Day 1) and Month 12 | Global CMRGlu index was related to grey matter of brain. Regional CMRGlu index was related to assessment of different regions of brain namely posterior cingulate gyrus, frontal lobe, parietal lobe, posterior temporal lobe, cerebellum, and medial temporal lobe. Evaluation of medial temporal lobe CMRGlu included assessment of medial anterior temporal lobe, paraHippocampal Ambiens gyrus, amygdala, and hippocampus. The regional CMRGlu index is directly proportional to the true metabolic rate of glucose. Baseline was defined as Day 1 of the 12 months treatment period. Change from Baseline is the value at indicated time point minus the Baseline value. Data has been presented for arithmetic mean; however, statistical analysis has been presented for adjusted or least square (LS) mean. | ClinicalTrials.gov |
| Secondary | Change From Baseline (Day 1) in CMRGlu Indices at Months 1 and 6 | Baseline (Day 1), Months 1, and 6 | Global CMRGlu index was related to grey matter of brain. Baseline measurement was performed on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. | ClinicalTrials.gov |
| Secondary | Change From Baseline (Day 1) in Delayed Free Recall Words at Months 1, 6, and 12 by Buschke Selective Reminding (BSR) Test | Baseline (Day 1), and Months 1, 6, and 12 | The BSR test included evaluating short-term memory of a participant to remember a list of unrelated words, to learn the words over 8 trials and to remember these words over 8 trials, and to remember these words during a 20 minute delay. The number of words recalled in delayed free recalls were analyzed. Other parameters analyzed included number recalled Trial 1 immediate, number recalled Trial 8 immediate, total number for all 8 immediate trials, and total number of uncued words recalled. Higher number of words recalled indicated better short term memory and positive treatment differences in these number of words recalled were indicative of superiority of drug over placebo. Baseline measurement was performed on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Statistical analysis is presented for difference of means. | ClinicalTrials.gov |
| Secondary | Change From Baseline (Day 1) in Delayed Free Recall Items Over Period by Stroop Colour Word Interference (SCWI) at Months 1, 6 and 12 | Baseline (Day 1), Months1, 6, and 12 | It is a measure of change from Baseline (Day 1) in clinical scale of AD status. A 3-card version test includes all card containing 50 items each. Participants were asked to complete all items and time in seconds was recorded. Participants first read color words printed in black, then named the printed color of the colored patches, and finally named the printed color of the colored words. The word condition was used to verify that participants were able to read colored words and time to perform color condition was considered as ' control'. The dependent variable was the time to complete the interference condition and the test could have presented in pencil and paper or on screen, both the ways. Change from Baseline is the value at indicated time point minus the Baseline value. Statistical analysis is presented for difference of means. | ClinicalTrials.gov |
| Secondary | Change From Baseline (Day 1) in Simplified Spatial Paired Associate Learning (SSPAL) Response Over Period | Baseline (Day 1), Months 1, 6, and 12 | Change from Baseline = value at the indicated time point minus the Baseline(Day1) value. SSPAL is a cognitive test that involves object-location memory and learning. It is used to examine cognitive deficits in AD. Participants were asked to sit 50 cm away from screen and different pictures (target and distracter) were shown on a monitor. Responses were acquired from response box. Participants were informed by visual feedback whether the response was correct or incorrect and the accuracy was collected automatically. SSPAL responses were captured as new accuracy and global accuracy. New accuracy was defined as proportion of accurate responses per participant for recall of any new item (picture). Global accuracy was defined as proportion of accurate responses per participant for recall of all new items and their displayed locations (i.e. right or left position on the screen). The possible range for new and global accuracy is 0(worst) to 1(best). Higher values indicate better performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline (Day 1) in Accuracy by Choice Reaction Time (CRT) Test Over Period | Baseline (Day 1) and up to 12 months | A motor reaction task was presented 4 runs of 50 trials each. In each trial, presentation of a central crosshair for 200 milliseconds (ms) was followed by display of a grey square for 800 ms. The square appeared in two of five possible positions relative to the crosshair (leftmost or rightmost). When the grey square became white, the participant was trained to press the a button. In each trial of the Simple Reaction Time Task, presentation of a central crosshair for 200 ms was followed by display of one square for 800 ms. For both simple and choice versions of the task, trial duration was 4000 ms maximum. The participant was immediately informed (by color changes of the white square) whether the response to each trial was correct or incorrect, and accuracy and reaction time (RT) are automatically calculated. Change from Baseline is the value at indicated time point minus the Baseline value. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Cognitive Test by Simple Reaction Time (SRT) Method Over Period | Baseline (Day 1) and up to 12 months | A motor reaction task was presented 4 runs of 50 trials each. In each trial, presentation of a central crosshair for 200 milliseconds (ms) was followed by display of a grey square for 800 ms. The square appeared in two of five possible positions relative to the crosshair (leftmost or rightmost). When the grey square became white, the participant was trained to press the a button. In each trial of the Simple Reaction Time Task, presentation of a central crosshair for 200 ms was followed by display of one square for 800 ms. For both simple and choice versions of the task, trial duration was 4000 ms maximum. The participant was immediately informed (by color changes of the white square) whether the response to each trial was correct or incorrect, and accuracy and reaction time (RT) are automatically calculated. Baseline measurement was performed on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-COG) Total Score Over Period | Baseline (Day 1), and Months 1, 6, and 12 | Change from Baseline is the value at indicated time point minus the Baseline value. ADAS-COG is a 13 item, 11 questionnaire assessment of range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The scale ranges from 0 to 70, with negative changes from Baseline indicating the improvement and positive changes indicating worsening of condition. Arithmetic means are presented as raw data; however, statistical analysis is based on LS means. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinician Based Impression of Change-plus (CBIC +) Score Over Period | Baseline (Day 1) and Months 1, 6, and 12 | The CBIC+ assessment for global functioning consists of a 7 point rating scale of severity and change with 1 indicating marked improvement and 7 indicating marked worsening. This scale was used to analyze clinically relevant effect. This was supposed to be performed by an independent investigator who is not a part of the ongoing study. Change from Baseline is the value at indicated time point minus the Baseline value. This scale was used to decide clinical status of AD. Arithmetic means are presented as raw data; however, statistical analysis has been presented for LS means. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Neuropsychiatric Inventory Score Over Period | Baseline (Day 1), Months 1, 6 and 12 | The NPI assesses the frequency and severity of behavioral disturbances in dementia across 10 domains. The total NPI score was calculated by adding all individual domains cores. The scale ranges from 0 to 120 , 0 indicating no / least burden and 120 indicating maximum burden. A negative change from Baseline indicated improvement. Baseline measurement was performed on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Mini-mental State Examination (MMSE) Score Over Period | Baseline (Day 1), and up to Month 12 | The MMSE consists of 11 categories of orientation, memory (recent and immediate), concentration, language, and praxis. The scale ranges from 0 to 30 with lower scores indicating greater cognitive impairment. Negative changes from Baseline indicate improvement and positive changes indicate increasing symptoms. Change from Baseline is the value at indicated time point minus the Baseline value. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Normalized Brain Volume Over Period | Baseline (Day 1), Month 6 and Month 12 | Normalized brain volume is a function of global changes in brain structure. Reduction in brain volume is indicative of reduction in Grey matter and thus the AD stage. The method used was structural magnetic resonance imaging (MRI). Change from Baseline is the value at indicated time point minus the Baseline value. Arithmetic means have been presented; however, statistical analysis is based upon the least square (LS) means. | ClinicalTrials.gov |
| Secondary | Percent Change From Baseline in Brain Volume Over Period | Baseline (Day 1), Month 6, and Month 12 | Percent volume change of brain is a function of global changes in brain structure. Reduction in brain volume is indicative of reduction in Grey matter and thus the AD stage. The method used was structural magnetic resonance imaging (MRI). Baseline value was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Arithmetic means have been presented; however, statistical analysis is based upon the LS means. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Fasting Plasma Glucose at Month 12 | Baseline (Day 1) and Month 12 | Fasting plasma glucose are indicative of Glucose metabolism. Baseline measurement was performed on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Glycosylated Hemoglobin [HbA1C] at Month 12 | Baseline (Day 1) and Month 12 | HbA1c levels are measure of glucose metabolism in body. Baseline value measurement was performed on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Lipid (Cholesterol) and Apo-lipoprotein Levels at Month 12 | Baseline (Day 1) and Month 12 | Lipid (cholesterol) and apo-lipoprotein (A and B) are biomarkers of glucose metabolism in blood. The method used for analyzes was positron emission tomography (PET) using radiolabelled \[18F\] -fluoro-deoxy-glucose (FDG). Baseline measurement was performed on Day 1. Change from baseline is the value at indicated time point minus the Baseline value. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Inflammatory Biomarkers (CD40, C-reactive Protein [CRP] , Interleukin [ IL ]-6, and Tumor Necrosing Factor [TNF]-Alpha) | Baseline (Day 1) and Month 12 | The inflammatory biomarkers namely CD40, C-reactive protein (CRP) , interleukin (IL)-6, and tumor necrosing factor (TNF)-alpha) were analyzed. Baseline measurement was performed on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Insulin Sensitivity Measured by Homeostasis Model Assessment of Insulin Resistance (HOMA IR) | Baseline (Day 1) and Month 12 | This is a measure of assessing insulin sensitivity. HOMA IR was calculated by multiplying fasting insulin by fasting plasma glucose and dividing the multiplied digit by 22.5. All samples were collected under fasting condition. Baseline measurement was performed on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. | ClinicalTrials.gov |
| Secondary | Number of Participants by Apo-lipoprotein -e (APOE Epsilon)-4 Allele Subtype | Up to 12 months | Participants were categorized into two major types namely those with APOE4 genotype and without APOE4 genotype. Further, 6 subtypes/ alleles of APOE4 gene (as mentioned in the categories below) were analyzed. Participants were also classified as having 0 or 1 or 2 copies of this gene. | ClinicalTrials.gov |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 12 months | Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. | ClinicalTrials.gov |
Outcomes 27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Baseline (Day 1) and Month 12 | Intent-to-treat (ITT) population included all participants from all subjects population who had at least one or more than one post-baseline pharmacodynamic (PD) or biomarker, efficacy, or pharmacogenetic (PGx) assessment. Only those participants available at the time of assessment were analyzed. | Milligrams per cubic centimeter(mg/cm^3) | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline (Day 1) in CMRGlu Indices at Months 1 and 6 | Baseline (Day 1), Months 1, and 6 | ITT population. Only those participants available at the time of assessment were analyzed | mg/cm^3 | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline (Day 1) in Delayed Free Recall Words at Months 1, 6, and 12 by Buschke Selective Reminding (BSR) Test | Baseline (Day 1), and Months 1, 6, and 12 | ITT population. Only the participants available at the time of assessment were analyzed. | Number of words recalled | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline (Day 1) in Delayed Free Recall Items Over Period by Stroop Colour Word Interference (SCWI) at Months 1, 6 and 12 | Baseline (Day 1), Months1, 6, and 12 | ITT population. Only the participants available at the time of assessment were analyzed. | Milliseconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline (Day 1) in Simplified Spatial Paired Associate Learning (SSPAL) Response Over Period | Baseline (Day 1), Months 1, 6, and 12 | ITT population. Only those participants available at the time of assessment were analyzed. | Proportion of accurate responses | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline (Day 1) in Accuracy by Choice Reaction Time (CRT) Test Over Period | Baseline (Day 1) and up to 12 months | ITT population. Only those participants available at the time of assessment were analyzed. | Percent accuracy | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Cognitive Test by Simple Reaction Time (SRT) Method Over Period | Baseline (Day 1) and up to 12 months | ITT population. Only those participants available at the time of assessment were analyzed. | Milliseconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-COG) Total Score Over Period | Baseline (Day 1), and Months 1, 6, and 12 | ITT population. Only the participants available at the time of assessment were analyzed. | Scores on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Clinician Based Impression of Change-plus (CBIC +) Score Over Period | Baseline (Day 1) and Months 1, 6, and 12 | ITT population. Only the participants available at the time of assessment were analyzed. | Scores on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Neuropsychiatric Inventory Score Over Period | Baseline (Day 1), Months 1, 6 and 12 | ITT population. Only the participants available at the time of assessment were analyzed. | Scores on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Mini-mental State Examination (MMSE) Score Over Period | Baseline (Day 1), and up to Month 12 | ITT population. Only those participants available at the time of assessment were analyzed. | Scores on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Normalized Brain Volume Over Period | Baseline (Day 1), Month 6 and Month 12 | ITT population. Only those participants available at the time of assessment were analyzed. | Cubic millimeter | MEAN | ClinicalTrials.gov |
| SECONDARY | Percent Change From Baseline in Brain Volume Over Period | Baseline (Day 1), Month 6, and Month 12 | ITT population. Only those participants available at the time of assessment were analyzed. | Percent change | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose at Month 12 | Baseline (Day 1) and Month 12 | ITT population. Only the participants available at the time of assessment were analyzed. | Millimoles per Liter | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin [HbA1C] at Month 12 | Baseline (Day 1) and Month 12 | ITT population. Only those participants available at the time of assessment were analyzed. | Percentage of HbA1c | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Lipid (Cholesterol) and Apo-lipoprotein Levels at Month 12 | Baseline (Day 1) and Month 12 | ITT population. Only those participants available at the time of assessment were analyzed. | Grams per Liter | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Inflammatory Biomarkers (CD40, C-reactive Protein [CRP] , Interleukin [ IL ]-6, and Tumor Necrosing Factor [TNF]-Alpha) | Baseline (Day 1) and Month 12 | ITT population. Only those participants available at the time of assessment were analyzed. | Nanograms per Liter | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Insulin Sensitivity Measured by Homeostasis Model Assessment of Insulin Resistance (HOMA IR) | Baseline (Day 1) and Month 12 | ITT population. Only those participants available at the time of assessment were analyzed. | HOMA IR score | MEAN | ClinicalTrials.gov |
| SECONDARY | Number of Participants by Apo-lipoprotein -e (APOE Epsilon)-4 Allele Subtype | Up to 12 months | PGx population included all ITT participants with evaluable PGx data (had consented to genotyping, provided and identified blood sample for genotyping and were successfully genotyped for at least one of the genetic markers under study). Only those participants available at time of assessment were analyzed. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 12 months | All subjects population included all randomized subjects who receive at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
Results by group 230
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Placebo | Grey matter | -0.2793 | Standard Deviation 0.48541 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Rosiglitazone | Grey matter | -0.0887 | Standard Deviation 0.34985 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Placebo | Posterior cingulate gyrus | -0.3143 | Standard Deviation 0.57567 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Rosiglitazone | Posterior cingulate gyrus | -0.0786 | Standard Deviation 0.36019 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Placebo | Frontal lobe | -0.3087 | Standard Deviation 0.55631 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Rosiglitazone | Frontal lobe | -0.1131 | Standard Deviation 0.36876 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Placebo | Parietal lobe | -0.3081 | Standard Deviation 0.50596 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Rosiglitazone | Parietal lobe | -0.1175 | Standard Deviation 0.33335 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Placebo | Posterior temporal lobe | -0.2771 | Standard Deviation 0.40458 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Rosiglitazone | Posterior temporal lobe | -0.1122 | Standard Deviation 0.32346 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Placebo | Cerebellum | -0.2523 | Standard Deviation 0.46730 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Rosiglitazone | Cerebellum | -0.0248 | Standard Deviation 0.38874 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Placebo | Medial temporal lobe | -0.1950 | Standard Deviation 0.33360 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Global and Regional Indices of Cerebral Metabolic Rate of Glucose (CMRglu) at Month 12 | Rosiglitazone | Medial temporal lobe | -0.0349 | Standard Deviation 0.32429 | Milligrams per cubic centimeter(mg/cm^3) | ClinicalTrials.gov |
| Change From Baseline (Day 1) in CMRGlu Indices at Months 1 and 6 | Placebo | Month 1 | -0.1049 | Standard Deviation 0.39301 | mg/cm^3 | ClinicalTrials.gov |
| Change From Baseline (Day 1) in CMRGlu Indices at Months 1 and 6 | Rosiglitazone | Month 1 | 0.0475 | Standard Deviation 0.46904 | mg/cm^3 | ClinicalTrials.gov |
| Change From Baseline (Day 1) in CMRGlu Indices at Months 1 and 6 | Placebo | Month 6 | -0.1556 | Standard Deviation 0.36397 | mg/cm^3 | ClinicalTrials.gov |
| Change From Baseline (Day 1) in CMRGlu Indices at Months 1 and 6 | Rosiglitazone | Month 6 | -0.0269 | Standard Deviation 0.35311 | mg/cm^3 | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Delayed Free Recall Words at Months 1, 6, and 12 by Buschke Selective Reminding (BSR) Test | Placebo | Delayed free recall, Month 1 | 0.1 | Standard Deviation 1.72 | Number of words recalled | ClinicalTrials.gov |
| Change From Baseline (Day 1) in Delayed Free Recall Words at Months 1, 6, and 12 by Buschke Selective Reminding (BSR) Test | Rosiglitazone | Delayed free recall, Month 1 | 0.2 | Standard Deviation 1.23 | Number of words recalled | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 40 | ClinicalTrials.gov | |
| Overall Study | STARTED | Rosiglitazone | 40 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo | 31 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Rosiglitazone | 31 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo | 9 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Rosiglitazone | 9 | ClinicalTrials.gov |
Adverse events 78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 3 | 40 | ClinicalTrials.gov | |
| other | Upper respiratory tract infection | Infections and infestations | Rosiglitazone | 4 | 40 | ClinicalTrials.gov | |
| other | Dizziness | Nervous system disorders | Placebo | 3 | 40 | ClinicalTrials.gov | |
| other | Dizziness | Nervous system disorders | Rosiglitazone | 3 | 40 | ClinicalTrials.gov | |
| other | Edema peripheral | General disorders | Placebo | 0 | 40 | ClinicalTrials.gov | |
| other | Edema peripheral | General disorders | Rosiglitazone | 3 | 40 | ClinicalTrials.gov | |
| other | Herpes zoster | Infections and infestations | Placebo | 1 | 40 | ClinicalTrials.gov | |
| other | Herpes zoster | Infections and infestations | Rosiglitazone | 3 | 40 | ClinicalTrials.gov | |
| other | Urinary tract infection | Infections and infestations | Placebo | 2 | 40 | ClinicalTrials.gov | |
| other | Urinary tract infection | Infections and infestations | Rosiglitazone | 3 | 40 | ClinicalTrials.gov | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 1 | 40 | ClinicalTrials.gov | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Rosiglitazone | 2 | 40 | ClinicalTrials.gov | |
| other | Dementia Alzheimer's type | Nervous system disorders | Placebo | 0 | 40 | ClinicalTrials.gov | |
| other | Dementia Alzheimer's type | Nervous system disorders | Rosiglitazone | 2 | 40 | ClinicalTrials.gov | |
| other | Depression | Psychiatric disorders | Placebo | 1 | 40 | ClinicalTrials.gov | |
| other | Depression | Psychiatric disorders | Rosiglitazone | 2 | 40 | ClinicalTrials.gov | |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 5 | 40 | ClinicalTrials.gov | |
| other | Fall | Injury, poisoning and procedural complications | Rosiglitazone | 2 | 40 | ClinicalTrials.gov | |
| other | Fatigue | General disorders | Placebo | 1 | 40 | ClinicalTrials.gov | |
| other | Fatigue | General disorders | Rosiglitazone | 2 | 40 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 40 | ClinicalTrials.gov |
| Total, all-cause mortality | Rosiglitazone | 0 | 40 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 32 | 40 | ClinicalTrials.gov |
| Total, other adverse events | Rosiglitazone | 33 | 40 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 6 | 40 | ClinicalTrials.gov |
| Total, serious adverse events | Rosiglitazone | 4 | 40 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 20930300 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rosiglitazone vs Placebo: deaths from any cause | Trial comparisons |
| Rosiglitazone vs Placebo: serious adverse events | Trial comparisons |
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Choice Reaction Time | Secondary outcome | ConductCognition |
| Delayed Recall Module | Secondary outcome | ConductCognition |
| Object Location Memory Task | Secondary outcome | ConductCognition |
| Paired Associate Learning | Secondary outcome | ConductCognition |
| Simple Reaction Time | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)