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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00531804

Enrollment

Registered

2007-09-19

Start date

2006-12-31

Completion date

2010-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

DRUGgantenerumab

Administered iv at escalating doses (7 cohorts)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
AEs, laboratory parameters, vital signs.	Throughout study
Pharmacokinetic parameters of R1450 in plasma	Throughout study

Secondary

Measure	Time frame
CSF biomarkers, clinical efficacy parameters.	Throughout study

Countries

Denmark, Israel, Netherlands, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026