Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease

NCT00381238 | Completed Phase 2 Results

• 1 other identifier: AVA104617
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 7

Brief Summary

This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Rosiglitazone

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AE's)

  An AE was defined as any untoward medical occurrence or clinical investigation in a participant, temporally associated with the use of a medicinal product, whether or not, considered related to the medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The number of participants with all AEs, drug related AEs, serious adverse events (SAEs), AE leading to permanent (prm) discontinuation (disc) of study drug or withdrawal were reported.

  From start of study medication (Wk 0) to Wk 50

Secondary Outcomes (10)

• Mean Change From Baseline in Mini Mental State Examination (MMSE) Total Score

  From baseline to Wk 48

• Number of Participants With SAEs

  From start of study medication (Wk 0) to Wk 50

• Number of Participants With AE of Peripheral Edema by Grade

  Up to Wk 50

• Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure

  Baseline (Wk 0) to Wk 50

• Mean Change From Baseline in Vital Signs-heart Rate (HR)

  Baseline (Wk 0) to Wk 50

Study Arms (1)

rosiglitazone

EXPERIMENTAL

Extended Release Tablets

Drug: rosiglitazone

Interventions

rosiglitazone DRUG

Extended Release Tablets

rosiglitazone

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject who has successfully completed the 12 Month Visit of 49653/461 (12 months of treatment) without tolerability issues, where in the opinion of the subject and of the investigator, it will be beneficial to continue treatment with RSG XR.
• Female subjects must be post-menopausal (i.e. \>6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD) a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures throughout the study and for 30 days after discontinuing study medication. The subject and their caregiver must ensure that the subject will continuously use contraceptive measures throughout the duration of the study.
• Subject is willing to participate in the extension study and has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative\[1\].\[1\] Where this is in accordance with local laws, regulations and ethics committee policy.
• Caregiver has provided full written informed consent on his or her own behalf prior to the performance of any protocol-specified procedure.

You may not qualify if:

• Subject had a serious adverse experience (SAE) or clinically significant laboratory abnormality during 49653/461, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at the end of 49653/461.
• The subject experienced a significant cardiovascular event during 49653/461 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome \[non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina\] or significant arrhythmia), unless a thorough cardiovascular evaluation has been performed which confirms that the subject does not have congestive heart failure, and is clinically stable.
• Treatment with a cholinesterase inhibitor, selegiline, memantine or any other treatment for cognitive symptoms/AD is initiated at the end of 49653/461.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Litchfield Park, Arizona, 85340, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85006, United States

Location

GSK Investigational Site

Sun City, Arizona, 85351, United States

Location

GSK Investigational Site

Belmont, Massachusetts, 02478, United States

Location

GSK Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

GSK Investigational Site

Durham, North Carolina, 27705, United States

Location

GSK Investigational Site

Montreal, Quebec, H4H 1R3, Canada

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 27, 2006
• Study Start: June 20, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 3, 2009
• Last Updated: May 23, 2017
• Results First Posted: May 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

US (6); CA (1)