Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease
This study has been terminated.
(Slow recruitment)
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00334568
First received: June 6, 2006
Last updated: August 6, 2010
Last verified: August 2010
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: Rosiglitazone XR (extended release) oral tablets Drug: Placebo |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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. ]
Secondary Outcome Measures:
- Changes in global and regional CMRglu as measured by [18F]FDG uptake. [ Time Frame: between baseline and 12 month point ]
- Global changes in brain structure from baseline as measured by structural MRI from baseline.Vital signs and ECGs. [ Time Frame: throughout study ]
Study Start Date: | December 2004 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Rosi XR
Rosi XR
|
Drug: Rosiglitazone XR (extended release) oral tablets
Rosi XR tablets
Other Name: Rosiglitazone XR (extended release) oral tablets
|
Placebo Comparator: Placebo
Placebo (matched)
|
Drug: Placebo
Placebo
|
Eligibility
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
More Information
No publications provided
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
ClinicalTrials.gov Identifier: | NCT00334568 History of Changes |
Other Study ID Numbers: | AVA100930 |
Study First Received: | June 6, 2006 |
Last Updated: | August 6, 2010 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by GlaxoSmithKline:
AVANDIA Alzheimers Disease |
Additional relevant MeSH terms:
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012