A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01397578
First received: July 18, 2011
Last updated: January 21, 2014
Last verified: January 2014

July 18, 2011
January 21, 2014
August 2011
January 2014   (final data collection date for primary outcome measure)
Change in brain amyloid load as assessed by amyloid PET imaging [ Time Frame: Baseline to Week 69 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01397578 on ClinicalTrials.gov Archive Site
  • Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease [ Time Frame: Baseline to Week 69 ] [ Designated as safety issue: No ]
  • Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging [ Time Frame: Baseline to Week 69 ] [ Designated as safety issue: No ]
  • Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score [ Time Frame: Baseline to Week 73 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: MABT5102A
    Repeating subcutaneous injection
  • Drug: MABT5102A
    Repeating intravenous infusion
  • Drug: placebo
    Repeating subcutaneous injection
  • Drug: placebo
    Repeating intravenous infusion
  • Experimental: A
    Interventions:
    • Drug: MABT5102A
    • Drug: placebo
  • Experimental: B
    Interventions:
    • Drug: MABT5102A
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
91
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of probable AD according to the NINCDS-ADRDA criteria
  • MMSE score of 18-26 points at screening
  • GDS-15 score of < 6
  • Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)
  • For patients currently receiving treatment with approved AD treatments (AChE inhibitors or memantine): Treatment initiated and continued for at least the last 3 months prior to randomization, at a stable dose for at least the last 2 months prior to randomization

Exclusion Criteria:

  • Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care
  • History or presence of clinically evident vascular disease potentially affecting the brain (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation)
  • History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (e.g., cerebral contusion)
  • Hospitalization within 4 weeks prior to screening
  • Previous treatment with MABT5102A or any other therapeutic that targets Abeta
  • Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Spain
 
NCT01397578
ABE4955g, GN00762
Not Provided
Genentech
Genentech
Not Provided
Study Director: Robert Paul, M.D., Ph.D. Genentech
Genentech
January 2014

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