Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00688207 |
The present pharmacokinetic study is designed to assess the pharmacokinetics of RSG XR as monotherapy in patients with mild Alzheimer's disease (AD) as such information will not be obtained from the current phase III trials . The study aims to enroll fourteen patients (seven of each APOE genotype). Each patient will receive a single oral dose of 4mg of RSG XR in the morning under fasted conditions and PK samples will be taken up to 36h.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: Rosiglitazone (Extended Release) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open Label, Single Oral Dose Study in Patients With Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) in This Population |
Estimated Enrollment: | 14 |
Study Start Date: | April 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 50 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | AVA109941, BRL-049653 |
Study First Received: | May 28, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00688207 |
Health Authority: | Germamy: State Office of Health & Social Affairs; Germany: Ethics Commission |
Rosiglitazone XR, Alzheimer's disease, PPAR agonist, BRL-049653. |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Rosiglitazone Cognition Disorders Delirium |
Hypoglycemic Agents Physiological Effects of Drugs Nervous System Diseases Tauopathies Pharmacologic Actions |