A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
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
1 other identifier
interventional
60
5 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2006
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 18, 2007
CompletedFirst Posted
Study publicly available on registry
September 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedNovember 2, 2016
November 1, 2016
3.8 years
September 18, 2007
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
AEs, laboratory parameters, vital signs.
Throughout study
Pharmacokinetic parameters of R1450 in plasma
Throughout study
Secondary Outcomes (1)
CSF biomarkers, clinical efficacy parameters.
Throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Copenhagen, 2100, Denmark
Unknown Facility
Ramat Gan, 52621, Israel
Unknown Facility
Amsterdam, 1081 GM, Netherlands
Unknown Facility
Malmo, 20502, Sweden
Unknown Facility
Stockholm, 14186, Sweden
Unknown Facility
Blackpool, FY20JH, United Kingdom
Unknown Facility
Glasgow, G20 0XA, United Kingdom
Unknown Facility
Southampton, SO30 3JB, United Kingdom
Unknown Facility
Swindon, SN3 6BW, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
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
September 18, 2007
First Posted
September 19, 2007
Study Start
December 1, 2006
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
November 2, 2016
Record last verified: 2016-11