Alzheimer's DiseasePhase 1NCT00688207
Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR)
A Phase 1 study testing Rosiglitazone (Extended Release) in people with Alzheimer's Disease, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Rosiglitazone (Extended Release)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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%
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Rosiglitazone (Extended Release)
- Keywords
- PPAR agonist,, Rosiglitazone XR,, BRL-049653., Alzheimer's disease,
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosiglitazone (Extended Release)Drug
open-label, single, oral, 4mg dose
| Study group | Role | What they receive |
|---|---|---|
| Rosiglitazone | Experimental | An open-label, single, oral dose of 4mg of rosiglitazone in the morning under fasted conditions Receives: Drug: Rosiglitazone (Extended Release) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (0-inf) and Cmax of RSG XR
Measured: Up to 36 hours
Secondary outcomes (1)
AUC(0-t), t1/2 and tmax for RSG XR
Measured: Up to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688207
- Sponsor's protocol ID
- AVA109941
- Status last verified
- Nov 2016
- First submitted
- 28 May 2008
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00688207
- Acronym / sponsor ID
- AVA109941
- Conditions
- Alzheimer's Disease
- Keywords
- PPAR agonist,, Rosiglitazone XR,, BRL-049653., Alzheimer's disease,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosiglitazone | Experimental | Drug: Rosiglitazone (Extended Release)An open-label, single, oral dose of 4mg of rosiglitazone in the morning under fasted conditions |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosiglitazone (Extended Release)open-label, single, oral, 4mg dose | Drug | Rosiglitazone |
Primary outcome
AUC (0-inf) and Cmax of RSG XR
Time frame: Up to 36 hours
1 secondary outcome
AUC(0-t), t1/2 and tmax for RSG XR
Time frame: Up to 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosiglitazone (Extended Release) in people with Alzheimer's Disease, run by GlaxoSmithKline at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (0-inf) and Cmax of RSG XR (time frame: Up to 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.