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Completed

NCT Number: NCT00945672

A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sahlgrenska Sjukhuset, CTC, Gothenburg, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females of non childbearing potential, age > or = 50.
  • Diagnosis of probable Alzheimer's disease, consistent with criteria from both:
  • National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
  • Diagnostic and Statistical Manual of Mental Disorders (DSM IV).
  • Mini-mental status exam score of 16-26 inclusive.
  • Rosen-Modified Hachinski Ischemia Score of < or = 4.

Exclusion criteria

  • Diagnosis or history of other demential or neurodegenerative disorders.
  • Diagnosis or history of clinically significant cerebrovascular disease.
  • Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities.
  • History of autoimmune disorders.
  • History of allergic or anaphylactic reactions.

Treatment and study plan

PF-04360365 10 mg/kg

Biological

10 mg/kg every 90 days (5 total doses)

PF-04360365 7.5 mg/kg

Biological

10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses)

Placebo

Drug

placebo administered every 90 days or monthly to match experimental treatment arms.

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Time frame: Day 1 up to 6 months after last dose of study medication (up to 18 months)

    An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 6 months after last dose (up to 18 months) that were absent before treatment or worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

  2. Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities

    Time frame: Baseline up to Month 18

    Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral edema, cerebral/meningeal enhancement, micro hemorrhage, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyper intensities) were assessed from structural magnetic resonance imaging (MRI). Participants with brain abnormality other than those listed above assessed using MRI scan were reported under 'other' category. Only those MRI findings in which at least 1 participant had event, were reported.

  3. Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)

    Time frame: Baseline up to Month 18

    Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI.

  4. Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M

    Time frame: Baseline, Month 13

    Quantitative amyloid imaging was performed using PET technique using [11C] Pittsburgh Compound B (PIB) for following brain areas: frontal, temporal, parietal and occipital cortices, anterior and posterior cingular cortex, cerebellum, pons, and subcortical white matter. For target regions of interest, beta-amyloid plaque imaging radiotracer (PIB) retention data was expressed as standard uptake value ratio (SUVR) which was defined as a ratio of radioactivity uptake of the target region relative to the cerebellum reference region. This outcome measure was planned to be analyzed only for cohort M.

  5. Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0

    Time frame: 0 hour on Day 0 (Day prior to dosing)

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  6. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1

    Time frame: 0 hour (pre-dose) on Day 1

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  7. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 1

    Time frame: 0.25 hours post-infusion start on Day 1

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  8. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 10: Cohort M

    Time frame: 216 hours post dose on Day 1 (samples taken on Day 10)

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  9. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 20: Cohort M

    Time frame: 456 hours post dose on Day 1 (samples taken on Day 20)

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  10. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 30: Cohort M

    Time frame: 0 hour (pre-dose) on Day 30

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  11. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 30: Cohort M

    Time frame: 0.25 hours post-infusion start on Day 30

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  12. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 40: Cohort Q

    Time frame: 936 hours post dose on Day 1 (samples taken on Day 40)

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  13. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 50: Cohort Q

    Time frame: 1176 hours post dose on Day 1 (samples taken on Day 50)

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  14. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 60: Cohort Q

    Time frame: 1416 hours post-dose on Day 1 (samples taken on Day 60)

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  15. Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 60: Cohort M

    Time frame: 0 hour (pre-dose) on Day 60

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  16. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 60: Cohort M

    Time frame: 0.25 hours post-infusion start on Day 60

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  17. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 90

    Time frame: 0 hour (pre-dose) on Day 90

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  18. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 90

    Time frame: 0.25 hours post-infusion start on Day 90

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  19. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120: Cohort M

    Time frame: 0 hour (pre-dose) on Day 120

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  20. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 120: Cohort M

    Time frame: 0.25 hours post-infusion start on Day 120

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  21. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 150: Cohort M

    Time frame: 0 hour (pre-dose) on Day 150

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  22. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 150: Cohort M

    Time frame: 0.25 hours post-infusion start on Day 150

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  23. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 180

    Time frame: 0 hour (pre-dose) on Day 180

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  24. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 180

    Time frame: 0.25 hours post-infusion start on Day 180

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  25. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 210: Cohort M

    Time frame: 0 hour (pre-dose) on Day 210

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  26. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 210: Cohort M

    Time frame: 0.25 hours post-infusion start on Day 210

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  27. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240: Cohort M

    Time frame: 0 hour (pre-dose) on Day 240

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  28. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 240: Cohort M

    Time frame: 0.25 hours post-infusion start on Day 240

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  29. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 270

    Time frame: 0 hour (pre-dose) on Day 270

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  30. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 270

    Time frame: 0.25 hours post-infusion start on Day 270

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  31. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300: Cohort M

    Time frame: 0 hour (pre-dose) on Day 300

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  32. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 300: Cohort M

    Time frame: 0.25 hours post-infusion start on Day 300

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  33. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 330: Cohort M

    Time frame: 0 hour (pre-dose) on Day 330

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  34. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 330: Cohort M

    Time frame: 0.25 hours post-infusion start on Day 330

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  35. Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 360

    Time frame: 0 hour (pre-dose) on Day 360

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  36. Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 360

    Time frame: 0.25 hours post-infusion start on Day 360

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  37. Mean Plasma Concentration of PF-04360365 at 720 Hours Post-dose on Day 360: Cohort Q

    Time frame: 720 hours post-dose on Day 360 (samples taken on Day 390)

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  38. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 390: Cohort M

    Time frame: 0 hour (pre-dose) on Day 390

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  39. Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 540: Cohort Q

    Time frame: 0 hours (pre-dose) on Day 540

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  40. Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540: Cohort M

    Time frame: 0 hour (pre-dose) on Day 540

    Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

  41. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0

    Time frame: 0 hour on Day 0 (Day prior to dosing)

    A-beta is a peptide fragment of the amyloid precursor protein (found in the brain of participants suffering from of Alzheimer's disease (AD). In this outcome, CSF concentration of 3 variants of A-beta were reported: A-beta (1-X), A-beta (1-40) and A-beta (1-42).

  42. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M

    Time frame: 216 hours post-dose on Day 1

  43. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M

    Time frame: 456 hours post-dose on Day 1

  44. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M

    Time frame: 0 hour (pre-dose) on Day 30

  45. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q

    Time frame: 936 hours post-dose on Day 1 (Samples taken on Day 40)

  46. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q

    Time frame: 1176 hours post-dose on Day 1 (Samples taken on Day 50)

  47. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q

    Time frame: 1416 hours post-dose on Day 1 (Samples taken on Day 60)

  48. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q

    Time frame: 0 hour (pre-dose) on Day 90

  49. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180

    Time frame: 0 hour (pre-dose) on Day 180

  50. Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360

    Time frame: 0 hour (pre-dose) on Day 360

Secondary outcomes

  1. Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18

    Time frame: Baseline, Month 3, 6, 9, 13, 18

    ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). The total score was calculated as the sum of the scores for the 11 items. ADAS-cog total score ranges from 0 (no impairment) to 70 (maximum impairment). Higher total and individual item scores indicate greater cognitive impairment.

  2. Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18

    Time frame: Baseline, Month 6, 13, 18

    DAD is a functional assessment based on interview with the caregiver of participants. It consists of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item scored as yes = 1, no = 0 and not applicable= N/A. A total score is obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A are not considered for the total score. DAD total score range from 0 (more dysfunction) to 100 (better function), with higher scores indicating better functioning.

  3. Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Month 13

    Time frame: Baseline, Month 13

    Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total MMSE score ranged from 0 (worst cognitive state) to 30 (best cognitive state), where higher score indicates better cognitive state.

  4. Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)

    Time frame: Cohort M&Q: 0 hour(hr) & 0.25 hrs post dose (pd) on Day (D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936,1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D 60, 0 hr & 0.25 hrs pd on D 30,120,150,210,240,300,330

  5. Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)

    Time frame: Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390,540; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330

  6. Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)

    Time frame: Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330

Other outcomes

  1. Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins

    Time frame: Cohort M&Q: Pre dose (0 hr) on Day 0, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30

  2. Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360

    Time frame: Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30

  3. Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360

    Time frame: Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30

  4. Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360

    Time frame: Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30

  5. Number of Participants With Measurable Serum Anti-Drug Antibody (ADA) Concentration

    Time frame: Day 1 up to Month 18

    A measurable ADA is defined as a serum anti-drug anti body response (total binding assay) greater than the lower limit of quantification (4.32).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 2 DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS/ PHARMACODYNAMICS OF PF-04360365 IN MILD TO MODERATE ALZHEIMER'S DISEASE PATIENTS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 24, 2009
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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