Trial Information

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

Status: Recruiting

Protocol Number: NN19866

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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

Brief 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. Target sample size is 80.

Study Phase: I

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Alzheimer Disease

Intervention Type: Drug

Intervention Name: R1450

Primary Outcome: 1. AEs, laboratory parameters, vital signs. Time frame: Throughout study 2. Pharmacokinetic parameters of R1450 in plasma Time frame: Throughout study

Key Secondary Outcomes: 1. CSF biomarkers, clinical efficacy parameters. Time frame: Throughout study

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.

Gender: Males or Females

Age Limits: Min: 50 Years Max: 90 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: December, 2006

Trial Registration Date: 10/17/2006

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
København, Denmark, 2100
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: May 13, 2008 at 2:49:42 PM


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