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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531804
• Other study ID #: NN19866
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2007
• Last updated: November 1, 2016
• Start date: December 2006
• Est. completion date: September 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• gantenerumab
Administered iv at escalating doses (7 cohorts)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Denmark,  Israel,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs, laboratory parameters, vital signs.		Throughout study	No
Primary	Pharmacokinetic parameters of R1450 in plasma		Throughout study	No
Secondary	CSF biomarkers, clinical efficacy parameters.		Throughout study	No