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NCT Number: NCT01656525

A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients

Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD.

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kansai region, Kansai, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a diagnosis of probable AD dementia, based on NINCDS/ADRDA criteria
  • Meet DSM-IV criteria for Dementia of the Alzheimer type
  • MMSE score : 16 to 26 etc.

Exclusion criteria

  • Meet the exclusion criteria of MRI at screening.
  • A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.

etc.

Treatment and study plan

gantenerumab

Drug

75 mg subcutaneous doses every 4 weeks for 24 weeks

Placebo

Drug

subcutaneous doses every 4 weeks for 24 weeks

Primary outcomes

  1. Number of participants with Adverse Events

    Time frame: 36 weeks

  2. Pharmacokinetic parameters of Gantenerumab in plasma

    Time frame: 36 weeks

  3. CSF/plasma ratios of Gantenerumab.

    Time frame: Baseline, Day183

Secondary outcomes

  1. Change from baseline in plasma Abeta

    Time frame: Baseline,Day183

  2. Change from baseline in plasma and CSF tau

    Time frame: Baseline,Day183

  3. Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog).

    Time frame: Baseline,Day85, 197, 253

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

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 and Pharmacokinetics of Gantenerumab Following Subcutaneous Injection in Japanese AD Patients

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 3, 2012
Registry last updated
Sep 19, 2014

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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