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

ClinicalTrials.gov ID: NCT00100282

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00100282
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: PRAECIS Pharmaceuticals Inc.; Industry
Enrollment: 125 participants

Conditions and interventions

Conditions

Alzheimer's Disease

Interventions

PPI-1019 (APAN) Drug

Drug

Eligibility (public fields only)

Age range: 50 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 2003 (Type not available)
Primary completion: Not listed
Completion: Jun 2005 (Type not available)
Last update posted: Sep 19, 2006

2003 – 2005

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Department of Psychiatry & Human Behavior at the University California, Irvine	Orange	California	92868	—
Global Medical Institutes LLC	Princeton	New Jersey	08540	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00100282, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 19, 2006 · Synced Nov 15, 2026