NCT01656525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2012

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

1.7 years

First QC Date

June 5, 2012

Last Update Submit

September 17, 2014

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

  • Number of participants with Adverse Events

    36 weeks

  • Pharmacokinetic parameters of Gantenerumab in plasma

    36 weeks

  • CSF/plasma ratios of Gantenerumab.

    Baseline, Day183

Secondary Outcomes (3)

  • Change from baseline in plasma Abeta

    Baseline,Day183

  • Change from baseline in plasma and CSF tau

    Baseline,Day183

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

    Baseline,Day85, 197, 253

Study Arms (4)

1

EXPERIMENTAL
Drug: Gantenerumab

2

EXPERIMENTAL
Drug: Gantenerumab

3

EXPERIMENTAL
Drug: Gantenerumab

4

EXPERIMENTAL
Drug: Placebo

Interventions

GantenerumabDRUG

75 mg subcutaneous doses every 4 weeks for 24 weeks

1
PlaceboDRUG

subcutaneous doses every 4 weeks for 24 weeks

4

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.
  • etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kansai region

Kansai, Japan

Location

Kanto region,

Kanto, Japan

Location

Kyushu region

Kyushu, Japan

Location

Tokai region

Toakai, Japan

Location

Tohoku region

Tōhoku, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

gantenerumab

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2012

First Posted

August 3, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

JP(5)