Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688207
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : November 7, 2016
Information provided by (Responsible Party):

May 28, 2008
June 2, 2008
November 7, 2016
April 2008
September 2008   (Final data collection date for primary outcome measure)
AUC (0-inf) and Cmax of RSG XR [ Time Frame: Up to 36 hours ]
AUC (0-inf) and Cmax of RSG XR
Complete list of historical versions of study NCT00688207 on Archive Site
AUC(0-t), t1/2 and tmax for RSG XR [ Time Frame: Up to 36 hours ]
AUC(0-t), t1/2 and tmax for RSG XR
Not Provided
Not Provided
Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR)
An Open Label Single Oral Dose Study in Patients With Mild Alzheimer's Disease to Assess the Pharmacokinetics of Extended Release Formulation of Rosiglitazone (RSG XR) in This Population
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.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Rosiglitazone (Extended Release)
open-label, single, oral, 4mg dose
Experimental: Rosiglitazone
An open-label, single, oral dose of 4mg of rosiglitazone in the morning under fasted conditions
Intervention: Drug: Rosiglitazone (Extended Release)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2008
September 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects with a clinical diagnosis of probable Alzheimer's disease in
  • accordance with NINCDS-ADRDA3 criteria for at least 3 months
  • Subject has mild Alzheimer's disease as defined by a MMSE score 18 to 26 inclusive
  • at Screening
  • Hachinski Ischemia Score ≤ 4 at Screening
  • Subjects aged ≥50 and ≤90 years.
  • Subject has not taken an approved Alzheimer's therapy in the last 30 days.
  • Current use of medication is in accordance with the criteria listed in Section 9.1).
  • Female subjects must be post-menopausal (i.e. >1 year without menstrual period),
  • surgically sterile, or agree to use adequate method of contraception for the duration of the study.
  • Female subjects who are pre-menopausal or who have been postmenopausal for <1 year must undertake pregnancy testing at screening, which must
  • be negative. More than one pregnancy test may be required (i.e., when the time period between enrolment and study treatment is > 7 days).
  • Pregnancy testing will be performed at screening, pre-dose (Day 1) and follow-up visit for all women of child-bearing potential and those who have been postmenopausal for less than 1 year. If clinically indicated, a urine or serum pregnancy test may be performed at anytime during the study.
  • Brain CT or MRI scan performed within the past 12 months or at Screening, showing no evidence of any other potential cause of dementia other than Alzheimer's disease.
  • Neurological exam without focal changes (excluding changes attributable to AD or peripheral trauma).
  • Subjects who live with or who have a regular caregiver who is willing to attend all visits, oversee the subject's compliance with the protocol specified procedures and study medication, and who is willing to report on subject's status.
  • Subject has provided full written informed consent prior to the performance of any protocol-specified procedure.
  • Subjects considered for enrolment must have a QTc (either QTc B (Bazett's
  • correction) or QTc F (Fridericia's correction)) <450msec at the Screening Visit, with the exception of subjects with bundle branch block (for whom either QTc B or QTc F must be <480msec).

Exclusion Criteria:

  • Diagnosis of possible, probable, or definite vascular dementia in accordance with NINDS-AIREN6 criteria
  • History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease.
  • Evidence of the following disorders: current vitamin B12 deficiency, positive syphilis serology or active thyroid dysfunction (particularly that suggestive of hypothyroidism), including abnormally high or low serum levels of thyroid stimulating hormone (TSH) that is clinically significant in the opinion of the investigator.
  • History of Type 1 diabetes mellitus or secondary diabetes mellitus.
  • Type 2 diabetes mellitus where the subject is being treated with insulin, a PPARγ agonist, or an insulin secretagogue (e.g. a sulfonylurea or glitinide).
  • Any patient with an HbA1c ≥8.5%
  • History or clinical/laboratory evidence congestive heart failure defined by the New York Heart Association criteria (Class I to IV cardiac status) (Appendix 4).
  • History of cardiovascular event within the last 6 months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia; or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled).
  • History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, major depressive disorder (according to DSM-IV) in the past year, or current active depression requiring initiation of treatment.
  • History or presence of gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
  • Clinically significant peripheral oedema at the time of screening.
  • Current or recent drug or alcohol abuse or dependence (defined by DSM-IV criteria for substance-related disorders), or recent or remote history of the same if that could be a contributing factor to the dementia.
  • Systolic blood pressure >165 or <90 mmHg or diastolic blood pressure >95 or <60 mmHg at the time of screening.
  • Clinically significant anaemia (i.e. haemoglobin <11 g/dL for males or <10 g/dL for females)
  • Patients with GFR ≤50ml/min (assessed by Cockcroft-Gault method ) .
  • ALT, AST, or alkaline phosphatase values >2.5 times the upper limit of normal, total bilirubin values >1.5 times the upper limit of normal, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis, Child-Pugh Class B/C).
  • History of a bone marrow transplant.
  • Positive hepatitis B virus, hepatitis C virus or HIV test at screening.
  • Subject is unable (with assistance, if appropriate) to take study medication or is at risk of non-compliance with study procedures.
Sexes Eligible for Study: All
50 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through following the timelines and process described on this site.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
November 2016

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