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

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ClinicalTrials.gov Identifier: NCT00334568
Recruitment Status : Terminated (Slow recruitment)
First Posted : June 8, 2006
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Rosiglitazone XR (extended release) oral tablets Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : December 2004
Primary Completion Date : July 2007
Study Completion Date : July 2007


Arm Intervention/treatment
Experimental: Rosi XR
Rosi XR
Drug: Rosiglitazone XR (extended release) oral tablets
Rosi XR tablets
Placebo Comparator: Placebo
Placebo (matched)
Drug: Placebo
Placebo



Primary Outcome Measures :
  1. 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 :
  1. Changes in global and regional CMRglu as measured by [18F]FDG uptake. [ Time Frame: between baseline and 12 month point ]
  2. Global changes in brain structure from baseline as measured by structural MRI from baseline.Vital signs and ECGs. [ Time Frame: throughout study ]


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334568


Locations
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2EF
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00334568     History of Changes
Other Study ID Numbers: AVA100930
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by GlaxoSmithKline:
AVANDIA
Alzheimers Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Rosiglitazone
Dementia
Tauopathies
Hypoglycemic Agents
Physiological Effects of Drugs