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

Alzheimer's Disease Clinical Trial

Official title:

Multiple Dose Safety and Preliminary Pharmacodynamic Study of PPI-1019 in Subjects With Mild-Moderate Alzheimer’s Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00100334
• Other study ID #: 1019-04-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 29, 2004
• Last updated: September 18, 2006
• Start date: December 2004
• Est. completion date: August 2005

Study information

• Verified date: September 2006
• Source: PRAECIS Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a single-center, double-blind, inpatient study followed by an outpatient, placebo-controlled, multiple-IV injection evaluation of the safety and tolerability of PPI-1019 in subjects with mild-moderate Alzheimer’s disease (AD). The primary objective of the study is to assess the safety of multiple IV injections of PPI-1019 in subjects with mild-moderate Alzheimer’s disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject has the ability to understand the requirements of the study, provide written informed consent, and abide by the requirements of the study. In addition, a member of the subject’s family or a legally authorized representative must consent to the subject’s participation in the study.

• Subject has a caregiver willing to assist the subject’s involvement in the study.

• Subject 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.

• Subject must have a cognitive deficit present for at least 1 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.

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

• Subject 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 subject is being treated for Alzheimer’s disease, it must be with a single cholinesterase inhibitor (donepezil, rivastigmine, or galantamine), with or without memantine, and with a dose which has been stable for at least 3 months prior to dosing.

• Subject performance status is = 3 on items 1 through 5 and = 2 on item 6 from the Degree of Disability Section of the “Rapid Disability Scale-2”

• Subject 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:

• Subject has participated in a clinical trial of another investigational drug or device, or has taken any experimental drug within 30 days prior to admission to the Phase 1 unit. (Subjects previously enrolled in 1019-03-01 may be enrolled in 1019-04-01, only after a wash-out period of 45 days.)

• Subject has a history compatible with vascular dementia as evidenced by a score of 5 or greater on the modified Hachinski Ischemia Scale.

• Subject has evidence of clinically significant unstable 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).

• Subject performance status is > 3 on items 1 through 5 and > 2 on item 6 from the Degree of Disability Section of the “Rapid Disability Scale-2.”

• Subject has diabetes that requires oral antidiabetic therapy or insulin.

• Subject has a systolic blood pressure (sitting) of greater than 160 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, a pulse (sitting or supine) less than 50 or greater than 85.

• Subject has any visual, hearing, or communication disabilities impairing his/her ability to participate in the study.

• Subject is being treated with anticholinergics and/or clinically relevant cytochrome P450 3A4 inducers/inhibitors. The use of other concomitant medications for stable medical conditions is acceptable provided drug and dosage are stable for at least 4 weeks prior to dosing.

• Subject is currently taking herbal supplements which interfere with drug metabolism, e.g. St. John’s wort, ginkgo biloba.

• Subject has tested positive for drugs of abuse (amphetamines, barbiturates, cocaine, phencyclidine, or cannabinoids) on screening or Day -1

• Subject has a current or past medical history of alcohol abuse.

• Subject has any elevations (> 1.2 x ULN) on screening or Day -1 for ALT, AST, bilirubin, creatinine, blood urea nitrogen, or alkaline phosphatase.

• Subject has any other screening or Day -1 laboratory values outside the normal ranges that are deemed clinically significant by the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• PPI-1019 (APAN)

Locations

Country	Name	City	State
United States	Silverado Senior Living	San Juan Capistrano	California

Sponsors (1)

Lead Sponsor	Collaborator
PRAECIS Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety will be assessed through the occurrence of clinical adverse events and the occurrence of clinically significant changes from baseline.