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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00531804
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 18, 2007
First Posted Date  ICMJE September 19, 2007
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE December 2006
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ]
  • Pharmacokinetic parameters of R1450 in plasma [ Time Frame: Throughout study ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2007)
Safety: Adverse events, laboratory safety, vital signs. PK: PK parameters of R1450 in plasma.
Change History Complete list of historical versions of study NCT00531804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
CSF biomarkers, clinical efficacy parameters. [ Time Frame: Throughout study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2007)
PD: CSF biomarkers, clinical efficacy parameters.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
Official Title  ICMJE 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
Brief Summary This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for 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, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: gantenerumab
Administered iv at escalating doses (7 cohorts)
Study Arms  ICMJE Experimental: 1
Intervention: Drug: gantenerumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2008)
60
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Israel,   Netherlands,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00531804
Other Study ID Numbers  ICMJE NN19866
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

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