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

This study has been completed.
Sponsor:
Information provided by:
PRAECIS Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00100282
First received: December 27, 2004
Last updated: September 18, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: PPI-1019 (APAN)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Single Dose Escalation Safety Study of PPI-1019 in Patients With Mild-Moderate Alzheimer’s Disease

Resource links provided by NLM:


Further study details as provided by PRAECIS Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Clinical (adverse events, vital signs, ECG) and laboratory (chemistry, hematology) parameters
  • Single dose pharmacokinetic parameters

Estimated Enrollment: 125
Study Start Date: May 2003
Estimated Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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

    1 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.

Exclusion Criteria:

  • 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 intends to use any concomitant medications during the study other than those described in Inclusion Criteria.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100282

Locations
United States, California
Department of Psychiatry & Human Behavior at the University California, Irvine
Orange, California, United States, 92868
United States, New Jersey
Global Medical Institutes LLC
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
PRAECIS Pharmaceuticals Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00100282     History of Changes
Other Study ID Numbers: 1019-03-01
Study First Received: December 27, 2004
Last Updated: September 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by PRAECIS Pharmaceuticals Inc.:
Mild-moderate Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014