drugset / Trial / NCT00100282

Safety Study of PPI-1019 in Patients With Mild-Moderate Alzheimer's Disease

NCT00100282 ↗

Phase 1 Completed 125 enrolled PRAECIS Pharmaceuticals Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multi-center, double-blind, inpatient study followed by outpatient, placebo-controlled, single-dose, dose-escalation evaluation of the safety and tolerability of PPI-1019 in patients with mild-moderate Alzheimer's disease (AD). Up to 12 sequential cohorts of 8 patients (6 active and 2 placebo) will be given a single PPI-1019 dose intravenously (IV) over 1 minute in order to determine a maximum tolerated dose (MTD). The MTD will be the dose immediately below the not-tolerated dose.

Timeline

Start
2003-05
Primary completion
—
Completion
2005-06

Drugs

EvaluationDrugModalityDoseRoute
Subject PPI-1019 Unknown — Intravenous

Indications