A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00531804

Purpose

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.

Condition	Intervention	Phase
Alzheimer Disease	Drug: R1450	Phase I

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Official Title:	A Randomized, Double-Blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of R1450 Following Intravenous Infusion in Alzheimer Disease

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Pharmacokinetic parameters of R1450 in plasma [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CSF biomarkers, clinical efficacy parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental	Drug: R1450 Administered iv at escalating doses (7 cohorts)

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531804

Locations

Denmark

COPENHAGEN, Denmark, 2100
Israel

RAMAT GAN, Israel, 52621
Netherlands

AMSTERDAM, Netherlands, 1007 MB
Sweden

STOCKHOLM, Sweden, 14186

MALMOE, Sweden, 20502
United Kingdom

BLACKPOOL, United Kingdom, FY2 0JW

SWINDON, United Kingdom, SN1 4HZ

SOUTHAMPTON, United Kingdom, SO30 3JB

GLASGOW, United Kingdom, G20 0XA

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NN19866
Study First Received:	September 18, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00531804
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009