- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00531804
A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
November 1, 2016 updated by: Hoffmann-La Roche
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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København, Denmark, 2100
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Ramat Gan, Israel, 52621
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Amsterdam, Netherlands, 1081 GM
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Malmoe, Sweden, 20502
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Stockholm, Sweden, 14186
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Blackpool, United Kingdom, FY20JH
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Glasgow, United Kingdom, G20 0XA
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Southampton, United Kingdom, SO30 3JB
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Swindon, United Kingdom, SN3 6BW
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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Administered iv at escalating doses (7 cohorts)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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AEs, laboratory parameters, vital signs.
Time Frame: Throughout study
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Throughout study
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Pharmacokinetic parameters of R1450 in plasma
Time Frame: Throughout study
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Throughout study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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CSF biomarkers, clinical efficacy parameters.
Time Frame: Throughout study
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Throughout study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
September 18, 2007
First Submitted That Met QC Criteria
September 18, 2007
First Posted (Estimate)
September 19, 2007
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN19866
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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