Treated HypertensionPhase 1/2NCT01780974
Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention
A Phase 1/2 study testing Lipoic Acid plus Omega-3 Fatty Acids in people with Treated Hypertension, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
The primary aim of the pilot study is to provide data that can be used to better determine sample size for the design of a larger clinical trial. The pilot will evaluate the effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing Alzheimer's Disease (AD). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Treated Hypertension
- What is being tested?
- Lipoic Acid plus Omega-3 Fatty Acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Oct 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years or older
- Non-demented: Montreal Cognitive Assessment > 26 and Clinical Dementia Rating = 0
- Diagnosis of Essential Hypertension with systolic 90-160 mm Hg and diastolic 60-90 mm Hg
- Stable dose of antihypertensive medication 4 month prior to study enrollment
- Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment
- Low Omega-3 fatty acid Status: Omega-3 index, < 4% of total fatty acid of combined docosahexaenoic acid and eicosapentanoic acid
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- Geriatric Depression Scale < 5
- General health status that will not interfere with the participant's ability to complete the study.
- Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator
- Sufficient English language skills to complete all testing
Who cannot join
- Alzheimer's, Dementia or other neurodegenerative disease.
- Health conditions such as cancer diagnosed < 5 years prior to enrollment (prostate cancer gleason grade < 3 and non metastatic skin cancers are acceptable), liver disease, history of ventricular fibrillation or ventricular tachycardia, major psychiatric disorder, central nervous system diseases (e.g. brain tumor, seizure disorder)
- Insulin dependent diabetes or uncontrolled diabetes (diabetes controlled on medications other than insulin are acceptable)
- Fish intake of one 6 ounce serving > once a week less than 4 months prior to enrollment
- Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 4 months prior to enrollment
- Lipoic Acid supplementation less than 1 month prior to enrollment
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- Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
- Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study.
- Enrollment in another treatment study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lynne Shinto, ND, MPH
Portland, Oregon, 97239
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Pilot Study: Lipoic Acid and Omega-3 Fatty Acid for Alzheimer's Disease Prevention
The primary aim of the pilot study is to provide data that can be used to better determine sample size for the design of a larger clinical trial. The pilot will evaluate the effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing Alzheimer's Disease (AD). The investigators will also collect data to evaluate recruitment rate, safety, and compliance over the 12 month study period.
Read the detailed description
The primary aim is to collect data so that we can determine effect size between lipoic acid plus omega-3 fatty acids and placebo on the primary outcome measure Trails B (executive function). This is designed as a pilot randomized, double-blind, placebo-controlled study with a 12 month intervention period. Thirty participants diagnosed with hypertension that is treated (systolic blood pressure 90-160 mm Hg, diastolic blood pressure 60-90 mm Hg) that have low omega-3 fatty acid levels, and normal cognitive function will be randomized to receive study drug or placebo.
- Conditions
- Treated Hypertension
- Being tested
- Lipoic Acid plus Omega-3 Fatty Acids, Placebo
- Keywords
- Hypertension, Vascular Risk, Alzheimer's Risk, fish oil, Lipoic acid
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipoic Acid plus Omega-3 Fatty AcidsDrug
Also called alpha lipoic acid, thioctic acid, fish oil concentrate, fish oil
alpha lipoic acid (racemic) and fish oil concentrate
PlaceboDrug
placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo LA capsules per day. Capsules will be taken with food or a meal. Receives: Drug: Placebo |
| Lipoic acid plus omega-3 fatty acids | Experimental | Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg docosahexaenoic acid (DHA) and 975 mg eicosapentaenoic acid (EPA) plus 2 LA capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal. Receives: Drug: Lipoic Acid plus Omega-3 Fatty Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trails Making Test Part B (Executive Function)
The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (1)
White Matter Hyperintensity Volume (Brain MRI)
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Treated HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynne Shinto, Oregon Health and Science University
- Investigators
- Lynne Shinto, ND, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780974
- Sponsor's protocol ID
- SFF01
- Status last verified
- Feb 2017
- First submitted
- 29 Jan 2013
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Lipoic Acid and Omega-3 Fatty Acid for Alzheimer's Disease Prevention
- ClinicalTrials.gov ID
- NCT01780974
- Acronym / sponsor ID
- SFF01
- Conditions
- Treated Hypertension
- Keywords
- Hypertension, Vascular Risk, Alzheimer's Risk, fish oil, Lipoic acid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Posted 7 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the pilot study is to provide data that can be used to better determine sample size for the design of a larger clinical trial. The pilot will evaluate the effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing Alzheimer's Disease (AD). The investigators will also collect data to evaluate recruitment rate, safety, and compliance over the 12 month study period.
Detailed description
The primary aim is to collect data so that we can determine effect size between lipoic acid plus omega-3 fatty acids and placebo on the primary outcome measure Trails B (executive function). This is designed as a pilot randomized, double-blind, placebo-controlled study with a 12 month intervention period. Thirty participants diagnosed with hypertension that is treated (systolic blood pressure 90-160 mm Hg, diastolic blood pressure 60-90 mm Hg) that have low omega-3 fatty acid levels, and normal cognitive function will be randomized to receive study drug or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThree placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo LA capsules per day. Capsules will be taken with food or a meal. |
| Lipoic acid plus omega-3 fatty acids | Experimental | Drug: Lipoic Acid plus Omega-3 Fatty AcidsThree 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg docosahexaenoic acid (DHA) and 975 mg eicosapentaenoic acid (EPA) plus 2 LA capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 55 years or older
- Non-demented: Montreal Cognitive Assessment > 26 and Clinical Dementia Rating = 0
- Diagnosis of Essential Hypertension with systolic 90-160 mm Hg and diastolic 60-90 mm Hg
- Stable dose of antihypertensive medication 4 month prior to study enrollment
- Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment
Key exclusion criteria (9 listed)
- Alzheimer's, Dementia or other neurodegenerative disease.
- Health conditions such as cancer diagnosed < 5 years prior to enrollment (prostate cancer gleason grade < 3 and non metastatic skin cancers are acceptable), liver disease, history of ventricular fibrillation or ventricular tachycardia, major psychiatric disorder, central nervous system diseases (e.g. brain tumor, seizure disorder)
- Insulin dependent diabetes or uncontrolled diabetes (diabetes controlled on medications other than insulin are acceptable)
- Fish intake of one 6 ounce serving > once a week less than 4 months prior to enrollment
- Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 4 months prior to enrollment
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 |
|---|---|---|
| Lipoic Acid plus Omega-3 Fatty AcidsAlso: alpha lipoic acid, thioctic acid, fish oil concentrate, fish oilalpha lipoic acid (racemic) and fish oil concentrate | Drug | Lipoic acid plus omega-3 fatty acids |
| Placeboplacebo capsules | Drug | Placebo |
Primary outcome
Trails Making Test Part B (Executive Function)
Time frame: Baseline, 6 months, and 12 months
The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
1 secondary outcome
White Matter Hyperintensity Volume (Brain MRI)
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Lynne Shinto, ND, MPH principal investigator
Oregon Health and Science University
2 sites 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 Lipoic Acid plus Omega-3 Fatty Acids in people with Treated Hypertension, run by Oregon Health and Science University at 2 sites 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 9 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Trails Making Test Part B (Executive Function) (time frame: Baseline, 6 months, and 12 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 7 Apr 2017.