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

Alzheimer's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656525
• Other study ID #: JP22431
• Secondary ID: JapicCTI-121849
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2012
• Last updated: September 17, 2014
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ministry of Health, Labor and Welfare Board Affiliation:JAPAN
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Gantenerumab
75 mg subcutaneous doses every 4 weeks for 24 weeks
• Gantenerumab
105 mg subcutaneous doses every 4 weeks for 24 weeks
• Gantenerumab
225 mg subcutaneous doses every 4 weeks for 24 weeks
• Placebo
subcutaneous doses every 4 weeks for 24 weeks

Locations

Country	Name	City	State
Japan	Kansai region	Kansai
Japan	Kanto region,	Kanto
Japan	Kyushu region	Kyushu
Japan	Tokai region	Toakai
Japan	Tohoku region	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events		36 weeks	Yes
Primary	Pharmacokinetic parameters of Gantenerumab in plasma		36 weeks	Yes
Primary	CSF/plasma ratios of Gantenerumab.		Baseline, Day183	Yes
Secondary	Change from baseline in plasma Abeta		Baseline,Day183	No
Secondary	Change from baseline in plasma and CSF tau		Baseline,Day183	No
Secondary	Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog).		Baseline,Day85, 197, 253	No