Trial information
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 type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety study
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:
- adult patients, 55-85 years of age;
- diagnosis of probable Alzheimer Disease, with symptoms >=1 year prior to screening;
- meets DSM-IV criteria for Alzheimer-type dementia.
Exclusion criteria:
- active major depressive disorder, or a history of bipolar disorder;
- history of schizophrenia;
- concurrent participation in a non-pharmacological trial with the key objective of improving cognition;
- patients who have previously participated in this study.
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: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Denmark
Sweden
United Kingdom
