Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00334568
First received: June 6, 2006
Last updated: January 10, 2013
Last verified: January 2013

June 6, 2006
January 10, 2013
December 2004
July 2007   (final data collection date for primary outcome measure)
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 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.
Complete list of historical versions of study NCT00334568 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in global and regional CMRglu between baseline and 12 month point as measured by [18F]FDG uptake.
  • Global changes in brain structure from baseline as measured by structural MRI from baseline.
  • Vital signs and ECGs.
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Rosiglitazone XR (extended release) oral tablets
    Rosi XR tablets
    Other Name: Rosiglitazone XR (extended release) oral tablets
  • Drug: Placebo
    Placebo
  • Experimental: Rosi XR
    Rosi XR
    Intervention: Drug: Rosiglitazone XR (extended release) oral tablets
  • Placebo Comparator: Placebo
    Placebo (matched)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
July 2007
July 2007   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00334568
AVA100930
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP