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A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00531804
First received: September 18, 2007
Last updated: November 3, 2014
Last verified: November 2014

September 18, 2007
November 3, 2014
December 2006
September 2010   (final data collection date for primary outcome measure)
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of R1450 in plasma [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Safety: Adverse events, laboratory safety, vital signs. PK: PK parameters of R1450 in plasma.
Complete list of historical versions of study NCT00531804 on ClinicalTrials.gov Archive Site
CSF biomarkers, clinical efficacy parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
PD: CSF biomarkers, clinical efficacy parameters.
Not Provided
Not Provided
 
A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4909832 Following Intravenous Infusion in AD Patients

This study will evaluate the safety, tolerability, pharmacokinetics and pharmaco dynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion fo r a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, to lerability and pharmacokinetics of the previous dose. The anticipated time on st udy treatment is 3-12 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
Drug: gantenerumab
Administered iv at escalating doses (7 cohorts)
Experimental: 1
Intervention: Drug: gantenerumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 50-90 years of age;
  • diagnosis of probable Alzheimer Disease, with symptoms >=1 year prior to screening;
  • meets DSM-IV criteria for Alzheimer-type dementia;
  • stabilised on approved medications for treatment of Alzheimer Disease for >=4 months prior to baseline.

Exclusion Criteria:

  • active major depressive disorder, or a history of bipolar disorder;
  • history of schizophrenia;
  • concurrent participation in a non-pharmacological trial with a key objective of improving cognition;
  • prior randomisation in any R1450 trial.
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Israel,   Netherlands,   Sweden,   United Kingdom
 
NCT00531804
NN19866
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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