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

NCT ID: NCT00334568

Last Updated: 2013-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-07-31

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rosi XR

Rosi XR

Group Type: EXPERIMENTAL

Rosiglitazone XR (extended release) oral tablets

Intervention Type: DRUG

Rosi XR tablets

Placebo

Placebo (matched)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Rosiglitazone XR (extended release) oral tablets

Rosi XR tablets

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

Other Identifiers

AVA100930

Identifier Type: -

Identifier Source: org_study_id