Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100282
Status:
COMPLETED
Last Update Posted:
2006-09-19
First Post:
2004-12-27
Brief Title:
Safety Study of PPI-1019 in Patients With Mild-Moderate Alzheimers Disease
Sponsor:
PRAECIS Pharmaceuticals Inc
Organization:
PRAECIS Pharmaceuticals Inc
Study Overview
Official Title:
Single Dose Escalation Safety Study of PPI-1019 in Patients With Mild-Moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Alzheimers 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None