Trial Information

Summary: A Single Dose Study of R1450 in Patients With Alzheimer Disease.

Status: No longer recruiting

Protocol Number: BN18726

Sponsor: F. Hoffmann-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous infusion of R1450 in patients with 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. Groups of patients will be randomized to receive R1450 or placebo, by intravenous infusion. The starting dose will be escalated 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 months, and the target sample size is <100 individuals. Target sample size is 30.

Study Phase: I

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety

Study Type:

Condition: Alzheimer Disease

Intervention Type: Drug

Intervention Name: R1450

Primary Outcome: 1. Adverse events, laboratory safety, vital signs.

Key Secondary Outcomes: 1. PK: Pk parameters of R1450 in plasma. PD: Neuropsychological test battery, mini mental state exam, neuropsychiatric inventory.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 55 Years Max: 85 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: April, 2006

Trial Registration Date: 08/16/2006

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: June 30, 2008 at 3:04:14 PM