Oxidative StressPhase 1NCT01731093
Safety and Tolerability of Antioxidant (AT-001)for Reducing Brain Oxidative Stress
A Phase 1 study testing AT-001 in people with Oxidative Stress, run by Alltech Life Sciences Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, bioavailability, and effectiveness of an organic yeast-selenium compound in reducing brain oxidative stress. Oxidative stress in the brain has been linked to a variety oif disorders including Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- AT-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2013
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women age > 64 years.
- Not demented by Hachinski Ischemic Index (≤ 4)
- English-speaking, to ensure compliance with study visit procedures.
- Female participants must not be pregnant or of childbearing potential, i.e. either surgically sterile or postmenopausal for > 1 year.
- Stable medical condition for three months prior to screening visit, with no clinically significant abnormalities of hepatic, renal, and hematologic function defined as follows: WBC within normal limits, platelets > 100,000, hemoglobin ≥11 mg/dL, srum creatinine ≤ 1.8 mg/dL, AST or ALT ≤ 1.5 ULN, no clinically significant abnormalities of other laboratory studies (CBC, chemistry panel, urinalysis).
- Non-diabetic confirmed by fasting serum glucose <126 mg/dL and on no oral hypoglycemic agents or insulin treatment.
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- Stable medications for 12 weeks prior to screening visit.
- Able to ingest oral medications.
- No contraindication to baseline MRI (metallic implants, pacemakers, shrapnel…etc.).
- Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.
Who cannot join
- Significant neurologic disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis or seizure disorder.
- Major depression in past 12 months (DSM-IV criteria) major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse.
- History of invasive cancer within the past two years (excluding non-melanoma skin cancer).
- Contra-indications to lumbar puncture (bleeding disorder, platelet count < 100,000, anticoagulant treatment, major structural abnormality or sepsis in the area of the lumbosacral spine, previous lower back surgery that would make LP technically difficult, hypersensitivity to lidocaine).
- Other conditions that will contribute to oxidative stress including but not limited to current smokers of cigarettes or cigars (within past month), history of alcohol or drug abuse as determined by medical history review.
- Known sensitivity, intolerance, or allergies to yeast or selenium-based compounds.
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- Daily intake of more than 75 µg selenium/day (US RDA) in the 90 days prior to enrollment.
- Use of any investigational agents within 90 days prior to screening.
- Major surgery within eight weeks prior to the Baseline Visit.
- Severe unstable medical illnesses, including uncontrolled cardiac conditions or heart failure (New York Heart Association Class III or IV).
- Extremes of body weight (<100 or >240 lbs) to exclude upper and lower 5th percentiles for age that may influence PK and safety data.
- Residence in a skilled nursing facility.
- Blindness, deafness, language difficulties or any other disability that may prevent the subject from participating or cooperating in the protocol.
- Safety laboratory values deemed clinically significant by investigator.
- Excluded Medications:
- Experimental drugs.
- Coumadin or heparin.
- Insulin or other hypoglycemic agents.
- Supplements containing more than 75 µg selenium/day (US RDA) in the 12 weeks prior to enrollment.
- The maximum dose of vitamin E (α-tocopherol) permitted in supplements will be 400 IU/day, vitamin C 1000 mg/day.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Alzheimer's Disease Research Center
Lexington, Kentucky, 40536
About this study
Official title: Multiple-ascending Dose Clinical Trial of the Safety and Tolerability of Antioxidant (AT-001) Treatment for Reducing Brain Oxidative Stress
The purpose of this study is to determine the safety, bioavailability, and effectiveness of an organic yeast-selenium compound in reducing brain oxidative stress. Oxidative stress in the brain has been linked to a variety oif disorders including Alzheimer's disease. Selenium is a very powerful antioxidant that could prove useful in reducing the harmful effects of oxidative stress in the brain and may help prevent diseases such as Alzheimer's. Our recent work has demonstrated that the specific type of selenium compound greatly influences it's ability to enhance brain health and prevent Alzheimer changes in mouse models of this disease.
This study will enroll 24 participants and will allow us to test the hypotheses that yeast-selenium supplementation is safe in the elderly, and that our specific formulation reduces brain oxidative stress.
Read the detailed description
Placebo-controlled, single-center, multiple ascending dose study. Approximately 8 healthy volunteers will be enrolled into 3 sequential cohorts, for a total of 24 enrolled subjects.
All subjects will be treated with study drug or placebo for 12 weeks. Subjects will be seen in the clinic for the following visits: Screening, Baseline (Day 1), Day 2, Day 4, Day 7 (Week 1), Week 2, Week 4, Week 6, Week 8,and Week 12 while on study drug. An additional safety visit at Week 14 (two weeks after study drug discontinuation) will be required of study participants.
Subjects will undergo blood draws, urine collection, assessment of vital signs, and review of Serious Adverse Events (SAEs) and Adverse Events (AEs) as well as changes in concomitant medical conditions and medications at every visit.
Routine medical examinations will be performed at study screening and enrollment, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 14 visits.
MRI will be performed on all subjects at Screening to ensure safety of lumbar puncture. Research procedures will also include lumbar puncture at the Screening and Week 12 visits.
A designated Data Safety Monitoring Board (DSMB) will evaluate safety in the subjects who have been enrolled and completed a cohort before escalating to the next cohort. The DSMB will review safety data (i.e. any AE or SAE) through Week 14. The committee may also request to review additional data.
The DSMB will also be convened in the event of a dose limiting toxicity (DLT) to determine whether stopping rules for accrual have been met.
- Conditions
- Oxidative Stress
- Being tested
- AT-001, Placebo
- Keywords
- aged, health, brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-001Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AT-001 | Experimental | AT-001 Receives: Drug: AT-001 |
| Placebo | Placebo comparator | Matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Safety and tolerability will be assessed by analysis of adverse events, including symptoms and abnormal findings on physical examinations and standard laboratory tests (serum chemistry, hematology, and urinalysis).
Measured: Baseline to week 14
Secondary outcomes (3)
Change in serum selenium levels
Measured: Baseline to week 12
Change in cerebrospinal fluid selenium levels
Measured: Baseline to week 12
Change in serum, urine, and cerebrospinal fluid isoprostanes
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- Alltech Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory A Jicha, MD, PhD, Principal investigator, University of KentuckyRonan Power, PhD, Study director, Alltech Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731093
- Sponsor's protocol ID
- 11-0967-F2L
- Status last verified
- Jan 2014
- First submitted
- 14 Nov 2012
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-ascending Dose Clinical Trial of the Safety and Tolerability of Antioxidant (AT-001) Treatment for Reducing Brain Oxidative Stress
- ClinicalTrials.gov ID
- NCT01731093
- Acronym / sponsor ID
- 11-0967-F2L
- Conditions
- Oxidative Stress
- Keywords
- aged, health, brain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alltech Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Nov 2012 (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.
The purpose of this study is to determine the safety, bioavailability, and effectiveness of an organic yeast-selenium compound in reducing brain oxidative stress. Oxidative stress in the brain has been linked to a variety oif disorders including Alzheimer's disease. Selenium is a very powerful antioxidant that could prove useful in reducing the harmful effects of oxidative stress in the brain and may help prevent diseases such as Alzheimer's. Our recent work has demonstrated that the specific type of selenium compound greatly influences it's ability to enhance brain health and prevent Alzheimer changes in mouse models of this disease.
This study will enroll 24 participants and will allow us to test the hypotheses that yeast-selenium supplementation is safe in the elderly, and that our specific formulation reduces brain oxidative stress.
Detailed description
Placebo-controlled, single-center, multiple ascending dose study. Approximately 8 healthy volunteers will be enrolled into 3 sequential cohorts, for a total of 24 enrolled subjects.
All subjects will be treated with study drug or placebo for 12 weeks. Subjects will be seen in the clinic for the following visits: Screening, Baseline (Day 1), Day 2, Day 4, Day 7 (Week 1), Week 2, Week 4, Week 6, Week 8,and Week 12 while on study drug. An additional safety visit at Week 14 (two weeks after study drug discontinuation) will be required of study participants.
Subjects will undergo blood draws, urine collection, assessment of vital signs, and review of Serious Adverse Events (SAEs) and Adverse Events (AEs) as well as changes in concomitant medical conditions and medications at every visit.
Routine medical examinations will be performed at study screening and enrollment, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 14 visits.
MRI will be performed on all subjects at Screening to ensure safety of lumbar puncture. Research procedures will also include lumbar puncture at the Screening and Week 12 visits.
A designated Data Safety Monitoring Board (DSMB) will evaluate safety in the subjects who have been enrolled and completed a cohort before escalating to the next cohort. The DSMB will review safety data (i.e. any AE or SAE) through Week 14. The committee may also request to review additional data.
The DSMB will also be convened in the event of a dose limiting toxicity (DLT) to determine whether stopping rules for accrual have been met.
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 |
|---|---|---|
| AT-001 | Experimental | Drug: AT-001AT-001 |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Men and women age > 64 years.
- Not demented by Hachinski Ischemic Index (≤ 4)
- English-speaking, to ensure compliance with study visit procedures.
- Female participants must not be pregnant or of childbearing potential, i.e. either surgically sterile or postmenopausal for > 1 year.
- Stable medical condition for three months prior to screening visit, with no clinically significant abnormalities of hepatic, renal, and hematologic function defined as follows: WBC within normal limits, platelets > 100,000, hemoglobin ≥11 mg/dL, srum creatinine ≤ 1.8 mg/dL, AST or ALT ≤ 1.5 ULN, no clinically significant abnormalities of other laboratory studies (CBC, chemistry panel, urinalysis).
Key exclusion criteria (20 listed)
- Significant neurologic disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis or seizure disorder.
- Major depression in past 12 months (DSM-IV criteria) major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse.
- History of invasive cancer within the past two years (excluding non-melanoma skin cancer).
- Contra-indications to lumbar puncture (bleeding disorder, platelet count < 100,000, anticoagulant treatment, major structural abnormality or sepsis in the area of the lumbosacral spine, previous lower back surgery that would make LP technically difficult, hypersensitivity to lidocaine).
- Other conditions that will contribute to oxidative stress including but not limited to current smokers of cigarettes or cigars (within past month), history of alcohol or drug abuse as determined by medical history review.
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 |
|---|---|---|
| AT-001 | Drug | AT-001 |
| Placebo | Drug | Placebo |
Primary outcome
Frequency of adverse events
Time frame: Baseline to week 14
Safety and tolerability will be assessed by analysis of adverse events, including symptoms and abnormal findings on physical examinations and standard laboratory tests (serum chemistry, hematology, and urinalysis).
3 secondary outcomes
Change in serum selenium levels
Time frame: Baseline to week 12
Change in cerebrospinal fluid selenium levels
Time frame: Baseline to week 12
Change in serum, urine, and cerebrospinal fluid isoprostanes
Time frame: Baseline to week 12
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 23 Jan 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.
Gregory A Jicha, MD, PhD principal investigator
University of Kentucky
Ronan Power, PhD study director
Alltech Inc.
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 AT-001 in people with Oxidative Stress, run by Alltech Life Sciences 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 10 inclusion and 20 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 23 Jan 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. 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?
Frequency of adverse events (time frame: Baseline to week 14). 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 23 Jan 2014.