Alzheimer's DiseasePhase 1/2NCT00100334
Safety Study of PPI-1019 in Subjects With Mild-Moderate Alzheimer's Disease
A Phase 1/2 study testing PPI-1019 (APAN) in people with Alzheimer's Disease, run by PRAECIS Pharmaceuticals Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- PPI-1019 (APAN)
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Aug 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Silverado Senior Living
San Juan Capistrano, California, 92675
About this study
Official title: Multiple Dose Safety and Preliminary Pharmacodynamic Study of PPI-1019 in Subjects With Mild-Moderate Alzheimer's Disease
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.
- Conditions
- Alzheimer's Disease
- Being tested
- PPI-1019 (APAN)
- Keywords
- Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI-1019 (APAN)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be assessed through the occurrence of clinical adverse events and the occurrence of clinically significant changes from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2004 (estimated)
- Study startDec 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- PRAECIS Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100334
- Sponsor's protocol ID
- 1019-04-01
- Status last verified
- Sep 2006
- First submitted
- 29 Dec 2004
- Last updated
- 19 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Dose Safety and Preliminary Pharmacodynamic Study of PPI-1019 in Subjects With Mild-Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00100334
- Acronym / sponsor ID
- 1019-04-01
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- PRAECIS Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Aug 2005
- First posted
- 30 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI-1019 (APAN) | Drug | – |
Primary outcome
Safety will be assessed through the occurrence of clinical adverse events and the occurrence of clinically significant changes from baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PPI-1019 (APAN) in people with Alzheimer's Disease, run by PRAECIS Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be assessed through the occurrence of clinical adverse events and the occurrence of clinically significant changes from baseline.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2006.