Skip to main content
Delfa

← Trials/Trial dossier/NCT00100282

CompletedPhase 1

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

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

Asset

PPI-1019 (APAN)

Listed sites

2

Recruiting sites

-

Enrollment

125

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-26•Study partner/caregiver required

Primary endpoints

•Clinical and laboratory parameters•Single dose pharmacokinetic parameters

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID1019-03-01
NCT IDNCT00100282

Timeline

Milestones

Study start2003-05 (month precision)
Study first posted2004-12-28estimated
Study completion2005-06 (month precision)
Last update posted2006-09-19estimated

Assets

Drug assets

PPI-1019 (APAN)

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

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

event count, event

Primary/protocol endpoint

Single dose pharmacokinetic parameters

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.