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TerminatedPhase 2
Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease
A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) on Cerebral Glucose Utilisation and Cognition in Subjects With Mild to Moderate Alzheimers Disease (AD)
Study population
Alzheimer’s disease
Key I/E criteria
•MMSE 16-26•Study partner/caregiver required
Primary endpoint
•Global and regional cerebral glucose metabolism/Cerebral Metabolic Rate
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Org study IDAVA100930
NCT IDNCT00334568
Study start2004-12 (month precision)
Study first posted2006-06-08estimated
Primary completion2007-07actual (month precision)
Study completion2007-07actual (month precision)
Last update posted2013-01-14estimated
Study populations
Who this study enrolls
Alzheimer’s disease
Eligibility
Who can enroll
Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Meets the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) criteria for Alzheimers disease, regardless of date of diagnosis relative to study entry date.
•Has an Alzheimers disease status of mild to moderate, as classified by a Mini Mental State Examination (MMSE) score of 16 - 26 inclusive at screening.
•Post-menopausal females defined as menopause is defined as >6 months without menstrual period with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However if indicated this should be confirmed by oestradiol and FSH levels consistent with menopause (according to local laboratory ranges).
•Women who are on HRT (hormone replacement therapy) treatment, and have not been confirmed as post-menopausal should be advised to use contraception.
•Has a permanent caregiver who is willing to attend all visits, oversee the subjects compliance with protocol-specified procedures and study medication, and report on subjects status. (Subjects living alone or in a nursing home are not eligible)
Exclusion criteria
•Has a history of or suffers from claustrophobia.
•Is unable to lie comfortably on a bed inside a PET camera with their head in the field of view for at least 60 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis).
•Has a history or presence of other neurological or other medical conditions that may influence the outcome or analysis of the PET scan results. Examples of such conditions include, but are not limited to stroke, traumatic brain injury, epilepsy or space occupying lesions.
•History of Type I or Type II diabetes mellitus.
•Fasting plasma glucose level >126 mg/dL (>7.0 mmol/L) or HbA1c >6.2%.
•History or clinical/laboratory evidence of moderate congestive heart failure defined by the New York Heart Association criteria (class II-IV.
Endpoints (3)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Neuroimaging
1 endpointSecondary/protocol endpoint
Global changes in brain structure from baseline as measured by structural MRI from baseline.Vital signs and ECGs.
Time frame:throughout study
Other (unclassified)
2 endpointsPrimary/protocol endpoint/low confidence
Change in global and regional cerebral glucose metabolism/Cerebral Metabolic Rate for glucose (CMRglu) as measured by the ratio of Ki to K1
Time frame:at baseline and 12 months.
change from baseline, improvement
Secondary/protocol endpoint/low confidence
Changes in global and regional CMRglu as measured by [18F]FDG uptake.
Time frame:between baseline and 12 month point
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.
