NCT00100282

CompletedPhase 1

Safety Study of PPI-1019 in Patients With Mild-Moderate Alzh...

PRAECIS Pharmaceuticals Inc.Source

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Other study identifiers

Sponsor study identifier

1019-03-01

Study Type

interventional

Reported enrollment (type unavailable)

125

Locations

1 country

Sites

2

Timeline

Study Start

May 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

June 2005

Date type not reported

This date has not been verified as actual or estimated.

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 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 125 participants
Study completion date: June 2005
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 27, 2004
Actual (reported)
First Posted
December 28, 2004
Actual (reported)
Study Completion
June 2005
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: September 19, 2006
Status Verified: September 2006
Last Update Submitted: September 18, 2006

Conditions

Alzheimer's Disease

Keywords

Mild-moderate Alzheimer's disease

Outcome Measures

Primary Outcomes (2)

Clinical (adverse events, vital signs, ECG) and laboratory (chemistry, hematology) parameters
Single dose pharmacokinetic parameters

Interventions

PPI-1019 (APAN)Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient has the ability to understand the requirements of the study, provide written informed consent, and abide by the requirements of the study.
Patient has a caregiver willing to assist the patient's involvement in the study.

Sponsors & Collaborators

PRAECIS Pharmaceuticals Inc.
Industrylead

Study Sites (2)

Department of Psychiatry & Human Behavior at the University California, Irvine

Orange, California, 92868, United States

Global Medical Institutes LLC

Princeton, New Jersey, 08540, United States

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 27, 2004

First Posted

December 28, 2004

Study Start

May 2003

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

June 2005

Date type not reported

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Patient is a male or female between the ages of 50 and 80 with a body mass index (BMI) below 31. Females must be post-menopausal at least

year or surgically sterilized.

Patient must have a cognitive deficit present for at least one year and meet DSM IV criteria for Alzheimer's Disease and meet National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for the presence of probable Alzheimer's Disease.

Patient's severity of Alzheimer's disease must be mild-moderate, documented with a Mini Mental State Exam (MMSE) score of 12-26.

Patient has a computerized tomography (CT) scan or magnetic resonance imaging (MRI) within the prior 12 months which is compatible with a diagnosis of probable AD.

If a patient is being treated for Alzheimer's disease, it must be with a single agent (donepezil, rivastigmine, galantamine, or memantine) and with a dose which has been stable for at least 3 months.

Patient is otherwise in good general health. Treatment of hypertension with no more than 2 medications and for hyperlipidemia with one agent is acceptable provided drugs and dosages have been stable for at least 30 days.

Patient agrees to abstain from alcohol and not take any other drugs, dietary supplements, or herbal therapies other than Mylanta®, ibuprofen, or a multivitamin for the length of the study (screening to follow-up visit Day 22).

Patient agrees not to donate blood or blood products while participating in this study and for at least 60 days after discontinuing from the study.

You may not qualify if:

Patient has participated in a clinical trial of another investigational drug or device, or has taken any experimental drug within 30 days prior to screening.
Patient has a history compatible with vascular dementia as evidenced by a score of 5 or greater on the modified Hachinski Ischemia Scale.
Patient has evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, or metabolic disease within the past 6 months (as determined by medical history, ECG results, chest x-ray, or physical examination). Findings of potential significance must be discussed with an appropriate sponsor clinician (or PRAECIS' designee) prior to patient entry.
Patient has a systolic blood pressure (sitting) of greater than 150 mmHg, a diastolic (sitting) greater than 95 mmHg, a decrease in systolic blood pressure of more than 30 mmHg upon standing for 2 minutes from a sitting or supine position, or a pulse (sitting or supine) less than 55 or greater than 85.
Patient has any visual, hearing, or communication disabilities impairing his or her ability to participate in the study.
Patient has taken any concomitant medication without the approval of the investigator within 7 days prior to Day 1.
Patient has tested positive for drugs of abuse (benzodiazepines, narcotics, amphetamines, barbiturates, sedatives, hypnotics, cocaine, phencyclidine, alcohol, or cannabinoids) on drug screening or Day -1.
Patient has any elevations (\> 1.2 x ULN) on screening or Day -1 for ALT, AST, bilirubin, creatinine, blood urea nitrogen, or alkaline phosphatase.
Patient has any other screening or Day -1 laboratory values outside the normal ranges that are deemed clinically significant by the investigator.

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

September 19, 2006

Record last verified: 2006-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00100282
Data provider: ClinicalTrials.gov
Source updated: 2006-09-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:14 UTC

Locations

US(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations