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A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease. | Clinical Trials | Clareo Health

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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

NCT00531804•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 90 years

Sex

ALL

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.

Locations (9)

Copenhagen, Denmark

Ramat Gan, Israel

Amsterdam, Netherlands

Malmo, Sweden

Stockholm, Sweden

Blackpool, United Kingdom

Glasgow, United Kingdom

Southampton, United Kingdom

Swindon, United Kingdom

Key Dates

Start Date

December 1, 2006

Primary Completion Date

September 1, 2010

Completion Date

September 1, 2010

Last Updated

November 2, 2016

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

gantenerumab

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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