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A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.

NCT ID: NCT00531804

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

gantenerumab

Intervention Type DRUG

Administered iv at escalating doses (7 cohorts)

Interventions

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gantenerumab

Administered iv at escalating doses (7 cohorts)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Copenhagen, , Denmark

Site Status

Ramat Gan, , Israel

Site Status

Amsterdam, , Netherlands

Site Status

Malmo, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Blackpool, , United Kingdom

Site Status

Glasgow, , United Kingdom

Site Status

Southampton, , United Kingdom

Site Status

Swindon, , United Kingdom

Site Status

Countries

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Denmark Israel Netherlands Sweden United Kingdom

Other Identifiers

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NN19866

Identifier Type: -

Identifier Source: org_study_id