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. Identifier: NCT00531804
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

September 18, 2007
September 19, 2007
November 2, 2016
December 2006
September 2010   (Final data collection date for primary outcome measure)
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ]
  • Pharmacokinetic parameters of R1450 in plasma [ Time Frame: Throughout study ]
Safety: Adverse events, laboratory safety, vital signs. PK: PK parameters of R1450 in plasma.
Complete list of historical versions of study NCT00531804 on Archive Site
CSF biomarkers, clinical efficacy parameters. [ Time Frame: Throughout study ]
PD: CSF biomarkers, clinical efficacy parameters.
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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 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.
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Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
Drug: gantenerumab
Administered iv at escalating doses (7 cohorts)
Experimental: 1
Intervention: Drug: gantenerumab
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.
Sexes Eligible for Study: All
50 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Denmark,   Israel,   Netherlands,   Sweden,   United Kingdom
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Hoffmann-La Roche
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016