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Completed

NCT Number: NCT00531804

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

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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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–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

gantenerumab

Drug

Administered iv at escalating doses (7 cohorts)

Primary outcomes

  1. AEs, laboratory parameters, vital signs.

    Time frame: Throughout study

  2. Pharmacokinetic parameters of R1450 in plasma

    Time frame: Throughout study

Secondary outcomes

  1. CSF biomarkers, clinical efficacy parameters.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 19, 2007
Registry last updated
Nov 2, 2016

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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