Last updated: 11/04/2018 05:10:43
Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease
GSK study ID
AVA100930
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change in global and regional cerebral glucose metabolism/Cerebral Metabolic Rate for glucose (CMRglu) as measured by the ratio of Ki to K1
Timeframe: at baseline and 12 months.
Secondary outcomes:
Changes in global and regional CMRglu as measured by [18F]FDG uptake.
Timeframe: between baseline and 12 month point
Global changes in brain structure from baseline as measured by structural MRI from baseline.Vital signs and ECGs.
Timeframe: throughout study
Interventions:
Drug: Rosiglitazone XR (extended release) oral tablets
Drug: Placebo
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Alzheimer's Disease
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
December 2004 to July 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
50 - 85 years
Accepts healthy volunteers
No
- 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 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).
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2EF
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2007-13-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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