Trials / Completed
CompletedNCT00100282
Safety Study of PPI-1019 in Patients With Mild-Moderate Alzheimer's Disease
Single Dose Escalation Safety Study of PPI-1019 in Patients With Mild-Moderate Alzheimer's Disease
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 125 (planned)
- Sponsor
- PRAECIS Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PPI-1019 (APAN) |
Timeline
- Start date
- 2003-05-01
- Completion
- 2005-06-01
- First posted
- 2004-12-28
- Last updated
- 2006-09-19
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00100282. Inclusion in this directory is not an endorsement.