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

• Sponsor: Chugai Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01656525
• Collaborator: (none)
• Enrollment: 28
• Locations: 5
• Arms: 4
• Duration (Months): 24
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: Gantenerumab; Drug: Gantenerumab; Drug: Gantenerumab; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Gantenerumab; 75 mg subcutaneous doses every 4 weeks for 24 weeks
Experimental: 2	Drug: Gantenerumab; 105 mg subcutaneous doses every 4 weeks for 24 weeks
Experimental: 3	Drug: Gantenerumab; 225 mg subcutaneous doses every 4 weeks for 24 weeks
Experimental: 4	Drug: Placebo; subcutaneous doses every 4 weeks for 24 weeks

Outcome Measures

Primary Outcome Measures

1. Number of participants with Adverse Events [36 weeks]

2. Pharmacokinetic parameters of Gantenerumab in plasma [36 weeks]

3. CSF/plasma ratios of Gantenerumab. [Baseline, Day183]

Secondary Outcome Measures

1. Change from baseline in plasma Abeta [Baseline,Day183]

2. Change from baseline in plasma and CSF tau [Baseline,Day183]

3. Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog). [Baseline,Day85, 197, 253]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kansai region	Kansai		Japan
2	Kanto region,	Kanto		Japan
3	Kyushu region	Kyushu		Japan
4	Tokai region	Toakai		Japan
5	Tohoku region	Tohoku		Japan

Sponsors and Collaborators

• Chugai Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chugai Pharmaceutical
• ClinicalTrials.gov Identifier: NCT01656525
• Other Study ID Numbers: JP22431; JapicCTI-121849
• First Posted: Aug 3, 2012
• Last Update Posted: Sep 19, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Alzheimer Disease; Antibodies, Monoclonal

Study Results

No Results Posted as of Sep 19, 2014