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Slow recruitment
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Clinical features in patients with the familial early onset forms and the sporadic forms of Alzheimers disease are similar, although the course of deterioration may be different. It would be very informative to examine the drug response of patients with Alzheimers disease by a certain genotype to find evidence favouring genotype-specific drug responses that may indicate genetically defined phenotypic differences in alzheimers disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosi XR | Experimental | Rosi XR |
|
| Placebo | Placebo Comparator | Placebo (matched) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone XR (extended release) oral tablets | Drug | Rosi XR tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in global and regional cerebral glucose metabolism/Cerebral Metabolic Rate for glucose (CMRglu) as measured by the ratio of Ki to K1 | at baseline and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in global and regional CMRglu as measured by [18F]FDG uptake. | between baseline and 12 month point | |
| Global changes in brain structure from baseline as measured by structural MRI from baseline.Vital signs and ECGs. | throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | Cambridgeshire | CB2 2EF | United Kingdom |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo |
| Drug |
Placebo |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |