Back to resultsA Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
gantenerumab
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
AEs, laboratory parameters, vital signs.
Pharmacokinetic parameters of R1450 in plasma
Secondary Outcome Measures
CSF biomarkers, clinical efficacy parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00531804
Brief Title
A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gantenerumab
Intervention Description
Administered iv at escalating doses (7 cohorts)
Primary Outcome Measure Information:
Title
AEs, laboratory parameters, vital signs.
Time Frame
Throughout study
Title
Pharmacokinetic parameters of R1450 in plasma
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
CSF biomarkers, clinical efficacy parameters.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
København
ZIP/Postal Code
2100
Country
Denmark
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
City
Amsterdam
ZIP/Postal Code
1081 GM
Country
Netherlands
City
Malmoe
ZIP/Postal Code
20502
Country
Sweden
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
City
Blackpool
ZIP/Postal Code
FY20JH
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO30 3JB
Country
United Kingdom
City
Swindon
ZIP/Postal Code
SN3 6BW
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
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