Alzheimer DiseasePhase 1NCT00795730
Multiple Dose Study Evaluating the Safety and Tolerability of NSA-789
A Phase 1 study testing NSA-789 in people with Alzheimer Disease and Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with Alzheimer's Disease Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Healthy Subjects
- What is being tested?
- NSA-789
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2009
- Phase
- Phase 1
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with Alzheimer's Disease)
- Women must be surgically sterile or postmenopausal
- Subjects with Alzheimer's Disease must be generally healthy, but may have a stable, chronic illness if well controlled.
Who cannot join
- Healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study.
- Subjects with Alzheimer's Disease may not be on any cholinesterase inhibitors such as donepezil (Aricept®) or rivastigmine (Exelon®) within 4 weeks of the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects and Subjects With Alzheimer's Disease
This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with Alzheimer's Disease
- Conditions
- Alzheimer Disease, Healthy Subjects
- Being tested
- NSA-789, placebo
- Keywords
- Alzheimer's Disease, schizophrenia
- Medical subject headings
- Alzheimer Disease, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSA-789Drug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Other: placebo |
| NSA-789 | Experimental | Not described Receives: Drug: NSA-789 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability
Measured: 6 months
Secondary outcomes (1)
Pharmacokinetic and pharmcodynamic parameters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795730
- Sponsor's protocol ID
- 3230A1-1002
- Status last verified
- Aug 2021
- First submitted
- 20 Nov 2008
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects and Subjects With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00795730
- Acronym / sponsor ID
- 3230A1-1002
- Conditions
- Alzheimer Disease, Healthy Subjects
- Keywords
- Alzheimer's Disease, schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009 (actual)
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Nov 2008 (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 multiple dose study of NSA-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with Alzheimer's Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: placebo |
| NSA-789 | Experimental | Drug: NSA-789 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with Alzheimer's Disease)
- Women must be surgically sterile or postmenopausal
- Subjects with Alzheimer's Disease must be generally healthy, but may have a stable, chronic illness if well controlled.
Key exclusion criteria (2 listed)
- Healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study.
- Subjects with Alzheimer's Disease may not be on any cholinesterase inhibitors such as donepezil (Aricept®) or rivastigmine (Exelon®) within 4 weeks of the start of the study.
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 |
|---|---|---|
| NSA-789 | Drug | NSA-789 |
| placebo | Other | placebo |
Primary outcome
Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability
Time frame: 6 months
1 secondary outcome
Pharmacokinetic and pharmcodynamic parameters
Time frame: 6 months
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 20 Aug 2021.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NSA-789 in people with Alzheimer Disease and Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer 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 3 inclusion and 2 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 20 Aug 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability (time frame: 6 months). 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 20 Aug 2021.