Alzheimer's DiseasePhase 1SEADNCT02142777
S-Equol in Alzheimer's Disease (SEAD) Trial
A Phase 1 study testing S -Equol in people with Alzheimer's Disease, run by Russell Swerdlow, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's Disease (AD). Read more about this study
- Who is it for?
- Ages 60 to 90 years, women only
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- S -Equol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Apr 2016
- 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 60 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Very mild (CDR 0.5) or mild (CDR 1) AD at time of last KU ADC assessment
- Have a study partner
- Speak English as primary language
Who cannot join
- No viable 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.)
- Use any type of estrogen replacement therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's Disease (AD).
Read the detailed description
Alzheimer's disease (AD) is a progressive brain disorder which causes memory and thinking problems. The exact cause of AD is unknown. Researchers believe mitochondria (the part of your cells that produces energy) might be linked to symptoms of AD. Some studies have shown that patients with Alzheimer's disease have reduced mitochondrial activity or have fewer mitochondria present in neurons. In this study, it is believed that by targeting mitochondria, we might learn more about its influence on AD symptoms.
Mitochondria have a receptor site for estrogen (a hormone) called estrogen receptor β (ERβ). When estrogen attaches to this site, it promotes mitochondrial function. Studies have also suggested ERβ stimulation can cause cells to create new mitochondria. More mitochondria, or increased activity of existing mitochondria, in the cell might have an impact on patients with Alzheimer's disease. One way to measure this increase in function is to look for the presence of an enzyme called COX in your blood. If a drug increases mitochondrial function, there will be an increase in COX concentration in the bloodstream.
By doing this study we hope to learn if S-equol, a compound that acts like estrogen in the body, causes such an increase in mitochondrial activity. We also hope to determine the tolerability of a therapeutic dose of S-equol. It is our goal to advance the understanding of AD, particularly in women.
- Conditions
- Alzheimer's Disease
- Being tested
- S -Equol, Placebo
- Keywords
- S-equol, COX activity
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S -EquolDrug
Also called AUS-131
We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.
PlaceboDrug
The placebo has no active ingredients but is made to look like the study drug.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | All study subjects will take a 10mg pill by mouth twice daily over a 6 week period. Subjects will receive either placebo or S -Equol. They will not know which they are receiving. Receives: Drug: S -Equol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet mitochondria cytochrome oxidase (COX) activity
Activity will be identified by the percentage of subjects who show an increase in COX activity while on the active treatment as compared to the COX activity while on placebo.
Measured: Change from Baseline to 6 Weeks
Secondary outcomes (1)
safety of S-equol
Determine if 10mg twice daily is a safe and well tolerated dose for persons with AD. Safety will be ascertained through the use of a questionnaire that queries a list of standard drug side effects.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionApr 2016
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russell Swerdlow, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ausio Pharmaceuticals, LLC
- Responsible party
- Sponsor-investigator, Russell Swerdlow, MD, University of Kansas Medical Center
- Investigators
- Russell H Swerdlow, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142777
- Sponsor's protocol ID
- STUDY00001228
- Acronym
- SEAD
- Status last verified
- Aug 2016
- First submitted
- 8 May 2014
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S-Equol in Alzheimer's Disease (SEAD) Trial
- ClinicalTrials.gov ID
- NCT02142777
- Acronym / sponsor ID
- SEAD / STUDY00001228
- Conditions
- Alzheimer's Disease
- Keywords
- S-equol, COX activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Russell Swerdlow, MDUniversity, hospital or other
- Collaborators
- Ausio Pharmaceuticals, LLC
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 May 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.
The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's Disease (AD).
Detailed description
Alzheimer's disease (AD) is a progressive brain disorder which causes memory and thinking problems. The exact cause of AD is unknown. Researchers believe mitochondria (the part of your cells that produces energy) might be linked to symptoms of AD. Some studies have shown that patients with Alzheimer's disease have reduced mitochondrial activity or have fewer mitochondria present in neurons. In this study, it is believed that by targeting mitochondria, we might learn more about its influence on AD symptoms.
Mitochondria have a receptor site for estrogen (a hormone) called estrogen receptor β (ERβ). When estrogen attaches to this site, it promotes mitochondrial function. Studies have also suggested ERβ stimulation can cause cells to create new mitochondria. More mitochondria, or increased activity of existing mitochondria, in the cell might have an impact on patients with Alzheimer's disease. One way to measure this increase in function is to look for the presence of an enzyme called COX in your blood. If a drug increases mitochondrial function, there will be an increase in COX concentration in the bloodstream.
By doing this study we hope to learn if S-equol, a compound that acts like estrogen in the body, causes such an increase in mitochondrial activity. We also hope to determine the tolerability of a therapeutic dose of S-equol. It is our goal to advance the understanding of AD, particularly in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Drug: S -Equol, Drug: PlaceboAll study subjects will take a 10mg pill by mouth twice daily over a 6 week period. Subjects will receive either placebo or S -Equol. They will not know which they are receiving. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Very mild (CDR 0.5) or mild (CDR 1) AD at time of last KU ADC assessment
- Have a study partner
- Speak English as primary language
Key exclusion criteria (3 listed)
- No viable 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.)
- Use any type of estrogen replacement therapy
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 |
|---|---|---|
| S -EquolAlso: AUS-131We will determine if the intervention (S-equol) alters platelet mitochondria COX activity. | Drug | Investigational |
| PlaceboThe placebo has no active ingredients but is made to look like the study drug. | Drug | Investigational |
Primary outcome
platelet mitochondria cytochrome oxidase (COX) activity
Time frame: Change from Baseline to 6 Weeks
Activity will be identified by the percentage of subjects who show an increase in COX activity while on the active treatment as compared to the COX activity while on placebo.
1 secondary outcome
safety of S-equol
Time frame: 6 Weeks
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 16 Aug 2016.
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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 H 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 Phase 1 study testing S -Equol 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 3 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 16 Aug 2016. 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 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?
platelet mitochondria cytochrome oxidase (COX) activity (time frame: Change from Baseline to 6 Weeks). 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 16 Aug 2016.