Alzheimer's DiseaseNCT02063308
Oxaloacetate Pharmacokinetics and Safety
A study testing Oxaloacetate (OAA) in people with Alzheimer's Disease, run by Russell Swerdlow, MD at 1 site in United States.
Trial summary
By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's disease who take OAA for one month have any side-effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Oxaloacetate (OAA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jun 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet criteria for Mild or Moderate AD
- Have a study partner
- Speak English as primary language.
Who cannot join
- Absence of a study partner
- Report a potentially confounding, serious medical risk such as type 1 diabetes, cancer, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's disease who take OAA for one month have any side-effects.
- Conditions
- Alzheimer's Disease
- Being tested
- Oxaloacetate (OAA)
- Keywords
- Oxaloacetate, OAA, AD, 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.
Oxaloacetate (OAA)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Oxaloacetate (OAA) | Experimental | 100 mg OAA to be taken twice daily over the course of a month Receives: Dietary Supplement: Oxaloacetate (OAA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between oral OAA intake and plasma levels
Baseline blood sample will be obtained before 100 mg OAA is administered. Blood samples to be drawn every 15 minutes starting 30 minutes after OAA administration.
Measured: Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing
Secondary outcomes (1)
safety of OAA in study participants
We will evaluate weights, blood counts, electrolytes, liver function tests, insulin levels, and plasma amino acid levels in subjects exposed to OAA for 1 month. These multiple measures will be used to generate a composite safety outcome measure.
Measured: Change from Baseline to Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russell Swerdlow, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Russell Swerdlow, MD, University of Kansas Medical Center
- Investigators
- Russell Swerdlow, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063308
- Sponsor's protocol ID
- STUDY00000581
- Status last verified
- Jul 2014
- First submitted
- 12 Feb 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxaloacetate Pharmacokinetics and Safety
- ClinicalTrials.gov ID
- NCT02063308
- Acronym / sponsor ID
- STUDY00000581
- Conditions
- Alzheimer's Disease
- Keywords
- Oxaloacetate, OAA, AD, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Russell Swerdlow, MDUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Feb 2014 (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.
By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's disease who take OAA for one month have any side-effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaloacetate (OAA) | Experimental | Dietary Supplement: Oxaloacetate (OAA)100 mg OAA to be taken twice daily over the course of a month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet criteria for Mild or Moderate AD
- Have a study partner
- Speak English as primary language.
Key exclusion criteria (2 listed)
- Absence of a study partner
- Report a potentially confounding, serious medical risk such as type 1 diabetes, cancer, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
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 |
|---|---|---|
| Oxaloacetate (OAA) | Dietary supplement | Oxaloacetate (OAA) |
Primary outcome
Correlation between oral OAA intake and plasma levels
Time frame: Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing
Baseline blood sample will be obtained before 100 mg OAA is administered. Blood samples to be drawn every 15 minutes starting 30 minutes after OAA administration.
1 secondary outcome
safety of OAA in study participants
Time frame: Change from Baseline to Month 1
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 24 Jul 2014.
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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.
Russell Swerdlow, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxaloacetate (OAA) in people with Alzheimer's Disease, run by Russell Swerdlow, MD 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 24 Jul 2014. 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.
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?
Correlation between oral OAA intake and plasma levels (time frame: Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing). 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 24 Jul 2014.